#Head And Neck Cancer – Pipeline Review

[sandlerresearch]

Immuno-Oncology - Market Analysis, Trends, Opportunities and Unmet Needs - Thematic Research published on

https://www.sandlerresearch.org/immuno-oncology-market-analysis-trends-opportunities-and-unmet-needs-thematic-research.html

Immuno-Oncology - Market Analysis, Trends, Opportunities and Unmet Needs - Thematic Research

Immuno-Oncology – Market Analysis, Trends, Opportunities and Unmet Needs – Thematic Research

Summary

Immuno-oncology (IO) describes the treatment of various cancers with the use of bispecific-antibodies, cancer vaccines, cell therapies, checkpoint modulators and oncolytic viruses. These classes of IO therapies achieved sales of ~$30B in 2019, which is projected to reach ~$95B by 2026. Of these, checkpoint modulators is the most valuable segment, forecast to achieve $66B in sales by 2026.

The field of (IO) is consolidating its presence in most major types of cancer, as there are now 22 marketed agents in the 7MM (United States, France, Germany, Italy, Spain, United Kingdom, and Japan), the majority being cancer vaccines, followed by 8 checkpoint modulators and 4 cell therapies.

IO agents are part of the standard of care in major cancer types, such as Melanoma, Lung, and Head & Neck Cancer. The clinical activity in the field is among the highest in oncology, with 4,822 clinical trials in the 7MM as of December 2020 and 422 drugs in clinical development.

The report “Immuno-Oncology – Market Analysis, Trends, Opportunities and Unmet Needs” assesses physician perceptions on use of immuno-oncology drugs in clinical practice in the US, 5EU (France, Germany, Italy, Spain, and the UK), and Japan. It also provides the landscape of marketed and pipeline immuno-oncology drugs across the five major classes (bispecific antibodies, cancer vaccines, cell therapies, checkpoint modulators and oncolytic viruses), opportunities, challenges, and unmet needs.

There is also a market analysis section with forecasts, as well as information on regulation and market access. The report combines information obtained from secondary sources and primary research with specialists and physicians from different disease areas within oncology who utilize immuno-oncology drug approaches during treatment.

Components of the report include primary and secondary research –

– Quotes from key opinion leaders and payers – Summary of immuno-oncology definitions and classifications – Overview of key marketed and pipeline immuno-oncology drugs, including bispecific antibodies, cancer vaccines, cell therapies, checkpoint modulators and oncolytic viruses – Trends in the immuno-oncology drug market – Call-outs of key information and details – Insight from GlobalData’s specialist healthcare analysts

Key Questions Answered –

– What impact will late-stage pipeline agents have on the market? Which class of IO drugs will have the highest peak sales, and why? – What are the current unmet needs in IO, which pipeline agents or strategies are positioned to counter these unmet needs? What are the opportunities for R&D? – How is the field of checkpoint modulation going to move forward? Which technologies are the most promising for combinations? – What is the regulatory landscape for IO agents in the US, the 5EU and Japan? – What is the current and future outlook of IO according to high prescribers?

Key findings from the report include –

– The field of immuno-oncology (IO) is consolidating its presence in most major types of cancer: There are currently 22 marketed IO products in the 7MM. Prophylactic and therapeutic cancer vaccines lead the category with 9 products, followed by checkpoint modulators with 8 approved drugs and cell therapies with 4 approved drugs. As of December 2020, there are 4,822 clinical trials investigating IO across the 7MM with 422 drugs in development. – Checkpoint modulation is the most valuable IO sector: The checkpoint modulation market was valued at $24B in 2019 globally and is forecast to reach $66.5B by 2026, with Merck’s Keytruda (pembrolizumab) leading the market. Key patent expiries for checkpoint modulators in the decade 2020-2030 will start eroding market value away from branded agents and into biosimilars. – Existing programs facilitate the approval and development of IO: Special new designations for certain components of IO can be assigned such as RMAT in the US and ATMP in the EU. Countries in the 7MM have set programs to expedite IO therapy approvals, especially when they address an unmet need or are targeting orphan indications. – High cost of therapy and need for personalized treatment using biomarkers remain as unmet needs: Despite new competitors entering the market, IO agents have retained or increased their very high prices, causing concern for their future use in most markets The need for better biomarkers to guide treatment decisions is well-documented and new efforts in the industry may move the needle in the next five years.

Scope

– Overview of immuno-oncology including classification of therapy and technologies, regulatory and market access details, product & company profiles. – Quotes from US- and 5EU-based key opinion leaders and payers. – Key topics covered for IO in the 7MM include trends, value chain, market analysis, opportunities, challenges and unmet needs and high-value deals. – Pipeline analysis: Comprehensive data split across different phases and indications, emerging novel trends under development, and analysis of the most promising late-stage pipeline drugs for each class of IO (Phase II – III). – Analysis of the key dynamics of the IO market. Insightful review of the key industry drivers and challenges. Deals and R&D strategies covered in detail to highlight business opportunities. – Robust analysis of high-prescriber survey conducted with 80 oncologists.

Reasons to Buy

The report will enable you to – – Develop and design your in-licensing and out-licensing strategies, using a detailed overview of current deals and technologies to identify companies with the highest potential. – Develop business strategies by understanding the trends shaping and driving the global immuno-oncology therapeutics market. – Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global immuno-oncology market in the future. – Design your development strategy through a review of potential novel targets or combinations across indications. – Understand the challenges and strategies impacting the development of immuno-oncology agents in preclinical studies and clinical trials. – Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage. – Organize your sales and marketing efforts by identifying the classes of IO and indications that present maximum opportunities for consolidations, investments and strategic partnerships.

[pharmaphorumuk]

NEC buys OncoImmunity to boost AI-based cancer research

Japanese multinational NEC has bought the Norway-based bioinformatics firm OncoImmunity, which develops proprietary machine learning software to support cancer R&D.

Following the acquisition for an undisclosed sum, OncoImmunity will become a subsidiary of NEC operating under the name of NEC OncoImmunity AS.

OncoImmunity focuses on research into the emergence of neoantigens – biomarkers that appear on tumour cells after they develop that can be used as a target for drugs.

Founded in 2014 OncoImmunity develops software that aims to select patients for immunotherapy, identifying neoantigen targets for personalised cancer vaccines and cell therapies, quickly enough to be used in the clinic.

The acquisition fits with NEC’s drug development strategy announced in May, which is based around using artificial intelligence (AI) to interrogate genomic data to discover neoantigen targets.

It is already working with France’s Transgene to create vaccine-based therapies targeting neoantigens.

Early stage clinical trials in head and neck cancer and ovarian cancer trials have already been cleared by the FDA and applications in the UK and France are under review.

NEC said that the OncoImmunity acquisition is “integral” to support this programme and develop its immunotherapy pipeline.

Under the new arrangements NEC will focus on drug discovery while NEC OncoImmunity will continue its neoantigen prediction service.

OncoImmunity’s CEO Richard Stratford said: “The OncoImmunity AS team are delighted to be joining the NEC Group and firmly believe that the union will realise great synergies, marrying the mutual strengths of OncoImmunity AS’s and NEC’s neoantigen prediction pipelines with NEC’s expertise in AI, data management and security.

“These synergies will help strengthen NEC’s individualised immunotherapy programmes, whilst simultaneously positioning NEC OncoImmunity AS as the leading neoantigen prediction service provider in the field.”

There are a whole host of companies using AI techniques in drug development: UK-based Exscientia and BenevolentAI have a series of tie-ups with various big pharma companies that hope to use the technology to reduce failure rates and discover new approaches to targeting diseases.

The post NEC buys OncoImmunity to boost AI-based cancer research appeared first on Pharmaphorum.

from Pharmaphorum https://pharmaphorum.com/news/nec-buys-oncoimmunity-to-boost-ai-based-cancer-research/

[htfmarketintelligence-blog]

Head And Neck Cancer – Pharmaceutical & Healthcare disease Pipeline Review, H2 2017

A new research document with title 'Head And Neck Cancer - Pipeline Review, H2 2017'  covering detailed analysis, Competitive landscape, forecast and strategies. The study covers geographic analysis and important players/vendors such as 3SBio, 4SC AG, AbbVie etc. The report will help user gain market insights, future trends and growth prospects for forecast. Request a sample report @ https://www.htfmarketreport.com/sample-report/772441-head-and-neck-cancer-pipeline-review-1 The latest Pharmaceutical and Healthcare disease pipeline guide Head And Neck Cancer - Pipeline Review, H2 2017, provides an overview of the Head And Neck Cancer (Oncology) pipeline landscape. Head and Neck Cancer is a cancer that arises in the head or neck region (in the nasal cavity, sinuses, lips, mouth, salivary glands, throat, or larynx). The common symptoms of cancer of the head and neck include persistent pain in the throat, pain or difficulty with swallowing, persistent hoarseness or a change in voice, pain in the ear and bleeding in the mouth or throat. The disease may be controlled by chemotherapy and radiation therapy. Report Highlights The Pharmaceutical and Healthcare latest pipeline guide Head And Neck Cancer - Pipeline Review, H2 2017, provides comprehensive information on the therapeutics under development for Head And Neck Cancer (Oncology), complete with analysis by stage of development, drug target, mechanism of action (MoA), route of administration (RoA) and molecule type. The guide covers the descriptive pharmacological action of the therapeutics, its complete research and development history and latest news and press releases. The Head And Neck Cancer (Oncology) pipeline guide also reviews of key players involved in therapeutic development for Head And Neck Cancer and features dormant and discontinued projects. The guide covers therapeutics under Development by Companies /Universities /Institutes, the molecules developed by Companies in Pre-Registration, Phase III, Phase II, Phase I, IND/CTA Filed, Preclinical, Discovery and Unknown stages are 1, 18, 96, 115, 5, 85, 18 and 7 respectively. Similarly, the Universities portfolio in Phase II, Phase I, Preclinical and Discovery stages comprises 12, 7, 16 and 3 molecules, respectively. Head And Neck Cancer (Oncology) pipeline guide helps in identifying and tracking emerging players in the market and their portfolios, enhances decision making capabilities and helps to create effective counter strategies to gain competitive advantage. The guide is built using data and information sourced from The proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations and featured press releases from company/university sites and industry-specific third party sources. Additionally, various dynamic tracking processes ensure that the most recent developments are captured on a real time basis. Scope - The pipeline guide provides a snapshot of the global therapeutic landscape of Head And Neck Cancer (Oncology). - The pipeline guide reviews pipeline therapeutics for Head And Neck Cancer (Oncology) by companies and universities/research institutes based on information derived from company and industry-specific sources. - The pipeline guide covers pipeline products based on several stages of development ranging from pre-registration till discovery and undisclosed stages. - The pipeline guide features descriptive drug profiles for the pipeline products which comprise, product description, descriptive licensing and collaboration details, R&D brief, MoA & other developmental activities. - The pipeline guide reviews key companies involved in Head And Neck Cancer (Oncology) therapeutics and enlists all their major and minor projects. - The pipeline guide evaluates Head And Neck Cancer (Oncology) therapeutics based on mechanism of action (MoA), drug target, route of administration (RoA) and molecule type. - The pipeline guide encapsulates all the dormant and discontinued pipeline projects. - The pipeline guide reviews latest news related to pipeline therapeutics for Head And Neck Cancer (Oncology) Buy this report @ https://www.htfmarketreport.com/buy-now?format=1&report=772441 Reasons to buy - Procure strategically important competitor information, analysis, and insights to formulate effective R&D strategies. - Recognize emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage. - Find and recognize significant and varied types of therapeutics under development for Head And Neck Cancer (Oncology). - Classify potential new clients or partners in the target demographic. - Develop tactical initiatives by understanding the focus areas of leading companies. - Plan mergers and acquisitions meritoriously by identifying key players and it’s most promising pipeline therapeutics. - Formulate corrective measures for pipeline projects by understanding Head And Neck Cancer (Oncology) pipeline depth and focus of Indication therapeutics. - Develop and design in-licensing and out-licensing strategies by identifying prospective partners with the most attractive projects to enhance and expand business potential and Scope. - Adjust the therapeutic portfolio by recognizing discontinued projects and understand from the know-how what drove them from pipeline. Companies Mentioned in the Report 3SBio Inc, 4SC AG, AbbVie Inc, Abion Inc, Adaptimmune Therapeutics Plc, Aduro BioTech Inc, Advaxis Inc, Advenchen Laboratories LLC, Affimed GmbH, Altor BioScience Corp, Ambrx Inc, amcure GmbH, Amgen Inc, arGEN-X BV, ArQule Inc, Array BioPharma Inc, Ascentage Pharma Group Corp Ltd, Aspyrian Therapeutics Inc, Astellas Pharma Inc, Astex Pharmaceuticals Inc, AstraZeneca Plc, Atara Biotherapeutics Inc, AVEO Pharmaceuticals Inc, Bayer AG, BeiGene Ltd, Benitec Biopharma Ltd, Bexion Pharmaceuticals LLC, BioDiem Ltd, Biohaven Pharmaceutical Holding Company Ltd, Biomics Biotechnologies Co Ltd, Bionovis SA, BioNTech AG, Biotest AG, Biothera Pharmaceutical Inc, Boehringer Ingelheim GmbH, Boston Biomedical Inc, Bristol-Myers Squibb Co, CBT Pharmaceuticals Inc, CEL-SCI Corp, Celgene Corp, Cell Medica Ltd, Celldex Therapeutics Inc, Cellectar Biosciences Inc, Celprogen Inc, Centrose LLC, Checkpoint Therapeutics Inc, Corvus Pharmaceuticals Inc, Cristal Therapeutics BV, Critical Outcome Technologies Inc, Curevac AG, Cyclacel Pharmaceuticals Inc, CytImmune Sciences Inc, CytomX Therapeutics Inc, Daiichi Sankyo Co Ltd, Denceptor Therapeutics Ltd, DNJ Pharma Inc, Dynavax Technologies Corp, Eisai Co Ltd, Eleven Biotherapeutics Inc, Eli Lilly and Co, Enzene Biosciences Ltd, Etubics Corp, Eureka Therapeutics Inc, F. Hoffmann-La Roche Ltd, Forty Seven Inc, Fujifilm Corp, G&E Herbal Biotechnology Co Ltd, Galectin Therapeutics Inc, Genelux Corp, Genentech Inc, GeneSegues Inc, Genexine Inc, Genmab A/S, GlaxoSmithKline Plc, Glenmark Pharmaceuticals Ltd, Gliknik Inc, Glycotope GmbH, Hanmi Pharmaceuticals Co Ltd, Hookipa Biotech AG, Horizon Pharma Plc, Hutchison MediPharma Ltd, Ignyta Inc, Immatics Biotechnologies GmbH, Immunocore Ltd, Immunomedics Inc, Immunovaccine Inc, Immunovative Therapies Ltd, Incyte Corp, Infinity Pharmaceuticals Inc, Innate Pharma SA, Innovation Pharmaceuticals Inc, Inovio Pharmaceuticals Inc, InteRNA Technologies BV, Iovance Biotherapeutics Inc, IRX Therapeutics Inc, ISA Pharmaceuticals BV, ISU ABXIS Co Ltd, Jiangsu Hengrui Medicine Co Ltd, Jiangsu Kanion Pharmaceutical Co Ltd, Johnson & Johnson, Jounce Therapeutics Inc, Juno Therapeutics Inc, Kite Pharma Inc, Kura Oncology Inc, Laboratoires Pierre Fabre SA, LATITUDE Pharmaceuticals Inc, Loxo Oncology Inc, Lytix Biopharma AS, Mabion SA, MacroGenics Inc, Madrigal Pharmaceuticals Inc., Marsala Biotech Inc, Mateon Therapeutics Inc, MaxiVAX SA, Meabco A/S, MedImmune LLC, Merck & Co Inc, Merck KGaA, Merrimack Pharmaceuticals Inc, Millennium Pharmaceuticals Inc, Mirati Therapeutics Inc, Moderna Therapeutics Inc, Molecular Templates Inc, Moleculin Biotech Inc, NanoCarrier Co Ltd, NantKwest Inc, Natco Pharma Ltd, NeoImmuneTech Inc, Neonc Technologies Inc, Neumedicines Inc, Northwest Biotherapeutics Inc, Novartis AG, Noxopharm Ltd, Oncobiologics Inc, Oncolys BioPharma Inc, Onconova Therapeutics Inc, OncoSec Medical Inc, Oncovir Inc, Ono Pharmaceutical Co Ltd, Oryx GmbH & Co KG, Otsuka Holdings Co Ltd, PDS Biotechnology Corp, Peregrine Pharmaceuticals Inc, Pfizer Inc, Pharma Mar SA, Plexxikon Inc, PNP Therapeutics Inc, Profectus BioSciences Inc, Provectus Biopharmaceuticals Inc, PsiOxus Therapeutics Ltd, R Pharm, Redx Pharma Plc, Regeneron Pharmaceuticals Inc, Reliance Life Sciences Pvt Ltd, Sareum Holdings Plc, Selecta Biosciences Inc, Shionogi & Co Ltd, Sierra Oncology Inc, Sillajen Biotherapeutics, Sinil Pharmaceutical Co Ltd, Sorrento Therapeutics Inc, Sound Pharmaceuticals Inc, Spherium Biomed SL, Sumitomo Dainippon Pharma Co Ltd, SuviCa Inc, SynCore Biotechnology Co Ltd, Systimmune Inc, Taiwan Liposome Company Ltd, Takara Bio Inc, Takis Srl, Tessa Therapeutics Pte Ltd, Theralase Technologies Inc, Theravectys SA, Tolero Pharmaceuticals Inc, Tosk Inc, Transgene SA, UbiVac LLC, Vaccibody AS, VasGene Therapeutics Inc, Vault Pharma Inc, Vaxeal Holding SA, Vectorite Biomedica Inc, Viracta Therapeutics Inc, Vyriad Inc Get customization & check discount for report @ https://www.htfmarketreport.com/request-discount/772441-head-and-neck-cancer-pipeline-review-1 Introduction 9 Head And Neck Cancer - Overview 10 Head And Neck Cancer - Therapeutics Development 11 Head And Neck Cancer - Therapeutics Assessment 54 Head And Neck Cancer - Companies Involved in Therapeutics Development 79 Head And Neck Cancer - Drug Profiles 166 Head And Neck Cancer - Dormant Projects 1402 Head And Neck Cancer - Discontinued Products 1413 Head And Neck Cancer - Product Development Milestones 1415 Appendix 1428List of Tables ....Continued View Detailed Table of Content @ https://www.htfmarketreport.com/reports/772441-head-and-neck-cancer-pipeline-review-1 Thanks for reading this article, you can also get individual chapter wise section or region wise report version like North America, Europe or Asia. Contact Us: CRAIG FRANCIS (PR & Marketing Manager) sales@htfmarketreport.com Ph: +1 (206) 317 1218

[kritikarehani]

Oropharyngeal Cancer (OPC) Market Insights, Epidemiology and Market Forecast 2030

The oropharynx consists of the structures in the oral cavity, back of the throat, including the base of the tongue, palatine tonsils, posterior pharyngeal wall, and soft palate. These are the well-known areas can only be visualized using special endoscopes or mirrors. There are many types of cancer of the oropharynx.

Oropharyngeal cancer is a type of head and neck cancer. Patients with oropharyngeal cancer related to HPV tend to present earlier in life as compared to those with tobacco-associated oropharyngeal cancer. The primary tumor is often difficult to see, hidden within the folds of the throat (tongue-base and tonsil.)

DelveInsight's "Oropharyngeal Cancer - Market Insights, Epidemiology, and Market Forecast-2030" report delivers an in-depth understanding of the Oropharyngeal Cancer, historical and forecasted epidemiology as well as the Oropharyngeal Cancer market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom) and Japan.

The Oropharyngeal Cancer market report provides current treatment practices, emerging drugs, Oropharyngeal Cancer market share of the individual therapies, current and forecasted Oropharyngeal Cancer market Size from 2017 to 2030 segmented by seven major markets. The Report also covers current Oropharyngeal Cancer treatment practice/algorithm, market drivers, market barriers and unmet medical needs to curate best of the opportunities and assesses the underlying potential of the market.

Geography Covered

· The United States

· EU5 (Germany, France, Italy, Spain, and the United Kingdom)

· Japan

Study Period: 2017-2030

View full report: https://www.delveinsight.com/report-store/oropharyngeal-cancer-market

Oropharyngeal Cancer Disease Understanding and Treatment Algorithm

Cancer specific to the oropharynx is called oropharyngeal cancer-a type of head and neck cancer that accounts for around thousands of newly diagnosed cases in the US every year. The leading cause of head and neck cancers is smoking tobacco, and as smoking has become less common in recent years, so has the occurrence for most head and neck cancers. The exception to this is oropharyngeal cancer, which is drastically increasing, especially in the younger population. The earliest stage oral cavity or oropharyngeal cancers are called stage 0 (carcinoma in situ), and then range from stages I through IV. As a rule, the lower the number, the less the cancer has spread. A higher number, such as stage IV, means cancer has spread more.

Early sign of oropharyngeal cancer often include lump in the neck. Besides this, patients often present or complain with lump or mass in the neck and back of the throat, difficulty or pain with swallowing, muffled voice, and pain in ear and throat may also appear.

There are few prognostic factors for oropharyngeal carcinoma such as HPV status, smoking history (pack-year smoking history of ten or more years), and tumor stage and nodal status.

The assessment of the primary tumor is based on inspection and palpation, when possible, and by indirect mirror examination. Beside this, other procedures may be done to evaluate the primary tumor such as Positron emission tomography–computed tomography scan (PET-CT) scan, Magnetic resonance imaging, Endoscopy, Laryngoscopy, Biopsy and p16 testing to assess for HPV status.

The DelveInsight Oropharyngeal Cancer market report gives a thorough understanding of the Oropharyngeal Cancer by including details such as disease definition, symptoms, causes, pathophysiology, diagnosis and treatment. 

Diagnosis 

This segment of the report covers the detailed diagnostic methods or tests for Oropharyngeal Cancer. 

Treatment 

It covers the details of conventional and current medical therapies available in the Oropharyngeal Cancer market for the treatment of the condition. It also provides Oropharyngeal Cancer treatment algorithms and guidelines in the United States, Europe, and Japan. 

Oropharyngeal Cancer Epidemiology  

The Oropharyngeal Cancer epidemiology division provide insights about historical and current Oropharyngeal Cancer patient pool and forecasted trend for every seven major countries. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. This part of the DelveInsight report also provides the diagnosed patient pool and their trends along with assumptions undertaken.  

Key Findings

· As per the Surveillance, Epidemiology, and End Results (SEER), approximately 1.2% of men and women will be diagnosed with oral cavity and pharynx cancer at some point during their lifetime (based on 2015–2017 data).

· According to the Stanford Medicine (US), Oropharyngeal Cancer cases typically are not diagnosed until the tumor metastasizes to the neck.

· As per the CDC (Centers for Disease Control and Prevention), approximately 70% of cancers of the oropharynx may be linked to HPV.

Request for sample pages: https://www.delveinsight.com/sample-request/oropharyngeal-cancer-market

Oropharyngeal Cancer Drug Chapters

The dynamics of the Oropharyngeal Cancer market is anticipated to change in the coming years owing to the rise in numbers of company’s taking interest in development of drugs for Oropharyngeal Cancer. Key players, such as Precigen, and others are involved in developing drugs for Oropharyngeal Cancer.

Emerging therapies includes Validive by Monopar Therapeutics, ISA101b plus Cemiplimab by ISA Pharmaceuticals/ Regeneron Pharmaceuticals

Drug chapter segment of the Oropharyngeal Cancer report encloses the detailed analysis of Oropharyngeal Cancer marketed drugs and late stage (Phase-III and Phase-II) pipeline drugs. It also helps to understand the Oropharyngeal Cancer clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug and the latest news and press releases.

Oropharyngeal Cancer Market Outlook

At present, there are several treatment choices for oropharyngeal cancer: surgery, radiation therapy, chemotherapy and targeted therapy. Treatment of oral cavity cancer is generally surgery followed by radiotherapy, whereas oropharyngeal cancers, which are more likely to be advanced at the time of diagnosis, are managed with radiotherapy or chemo-radiation. Even after the surgery, cancer cell can be seen, therefore, few patients may be given chemotherapy or radiation therapy to kill any cancer cells that are left. Treatment given after the surgery, to lower the risk that the cancer will come back, is called adjuvant therapy.

The use of surgery in HPV-positive oropharyngeal cancer and the application of minimally invasive techniques to avoid or reduce required doses of adjuvant treatment have become important areas of study. Trans-oral laser surgery (TLS) was first popularized by Steiner in Germany. There has been increasing experience with TLS, but its use for oropharyngeal tumors has been limited to a few high-volume centers in the US and European units in the UK, France, and Germany

The Oropharyngeal Cancer market outlook of the report helps to build the detailed comprehension of the historic, current, and forecasted Oropharyngeal Cancer market trends by analyzing the impact of current therapies on the market, unmet needs, drivers and barriers and demand of better technology. 

According to DelveInsight, Oropharyngeal Cancer market in 7MM is expected to change in the study period 2017-2030.

Scope of the Report

· The report covers the descriptive overview of Oropharyngeal Cancer, explaining its causes, signs and symptoms, pathophysiology, diagnosis and currently available therapies

· Comprehensive insight has been provided into the Oropharyngeal Cancer epidemiology and treatment in the 7MM

· Additionally, an all-inclusive account of both the current and emerging therapies for Oropharyngeal Cancer are provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape

· A detailed review of Oropharyngeal Cancer market; historical and forecasted is included in the report, covering drug outreach in the 7MM

· The report provides an edge while developing business strategies, by understanding trends shaping and driving the global Oropharyngeal Cancer market

Download full report: https://www.delveinsight.com/report-store/oropharyngeal-cancer-market

Request for sample pages: https://www.delveinsight.com/sample-request/oropharyngeal-cancer-market

About DelveInsight DelveInsight is a leading Business Consultant, and Market Research Firm focused exclusively on life sciences. It supports pharma companies by providing end to end comprehensive solutions to improve their performance.

[stella01wilson]

The Neoantigen Targeted Therapies Market is estimated to be worth USD 3 Billion in 2030, predicts Roots Analysis

Advances in bioinformatics and genomic data analysis have enabled the identification of cancer antigens that are generally overlooked during immune surveillance; these neoantigens have been shown to possess substantial therapeutic potential

Roots Analysis is pleased to announce the publication of its recent study, titled, “Neoantigen Targeted Therapies Market, 2019-2030.”

The report features an extensive study of the current market landscape, offering an informed opinion on the likely adoption of these therapeutics over the next decade. It features an in-depth analysis, highlighting the capabilities of various stakeholders engaged in this domain. In addition to other elements, the study includes:

·        A detailed assessment of the current market landscape of developers engaged in the development of neoantigen targeted therapies.

·        Detailed profiles of developers of neoantigen targeted therapies (shortlisted on the basis of the number of pipeline products).

·        A detailed publication analysis of close to 300 peer-reviewed, scientific articles published during the period 2015-2019 (till February), highlighting the research focus within the industry.

·        An in-depth analysis of the various patents that have been filed / granted related to neoantigens.

·        An analysis of the various partnerships pertaining to neoantigen targeting therapies.

·        An analysis of the investments made at various stages of development in companies that are focused on developing neoantigen targeted therapies.

A detailed market forecast, featuring analysis of the current and projected future opportunity across key market segments (listed below)

Target Disease Indication

·        Bone and Cartilage Cancer

·        Colorectal Cancer

·        Head and Neck Cancer

·        Renal Carcinoma

·        Hepatocellular Carcinoma

·        Lung Cancer

·        Gynecological Cancer

·        Others

Type of Treatment

·        Personalized

·        Off-the-shelf

Type of Immunotherapy

·        Dendritic Cell Vaccine

·        DNA / RNA-based Vaccine

·        Protein / Peptide-based Vaccine

·        TIL-based Therapy

Route of Administration

·        Intradermal

·        Intravenous

·        Subcutaneous

·        Others

Key Geographical Region

·        North America (US)

·        Europe (UK, Germany, France, Italy, and Spain

·        Rest of the World

Transcripts of interviews held with the following senior level representatives of stakeholder companies:

·        Gabriel Nistor, Chief Scientific Officer, AIVITA Biomedical

·        Ella Sorani, Vice President Research and Development, BioLineRx

·        Heinz Lubenau, Chief Operating Officer and Co-Founder, VAXIMM

Key companies covered in the report

·        Bavarian Nordic

·        Genocea Biosciences

·        Gradalis

·        Immunicum

·        Immunovative Therapies

·        Iovance Biotherapeutics

·        Medigene

·        Neon Therapeutics

·        Precision Biologics

·        Vaxon Biotech

For more information, please click on the following link:

https://www.rootsanalysis.com/reports/view_document/neoantigen-targeted-therapies-market-2019-2030/257.html    

About Roots Analysis

Roots Analysis is one of the fastest growing market research companies, sharing fresh and independent perspectives in the bio-pharmaceutical industry. The in-depth research, analysis and insights are driven by an experienced leadership team which has gained many years of significant experience in this sector. If you’d like help with your growing business needs, get in touch at info@rootsanalysis.com

Contact Information

Roots Analysis Private Limited

Gaurav Chaudhary

+1 (415) 800 3415

Gaurav.Chaudhary@rootsanalysis.com

[chestnutpost]

Bayer Data at ASCO 2019 Highlights Commitment to Evolving the Cancer Treatment Paradigm

WHIPPANY, N.J., May 13, 2019 /PRNewswire/ — Bayer will present research from its expanding oncology portfolio at the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO) 2019, taking place May 31 to June 4 in Chicago. The presentations highlight new findings from assets on the company’s key areas of focus, some of which have the potential to be first-in-class. Bayer already has five marketed compounds across nine indications and is committed to expanding this portfolio by bringing forward valuable additional projects.

For Vitrakvi® (larotrectinib), findings from four analyses across clinical studies in patients with solid tumors harboring NTRK gene fusions will be presented: one oral presentation on the expanded pediatric dataset, one oral presentation focusing on data from Vitravki in patients with brain metastases or primary central nervous system (CNS) tumors, one poster presentation on patient-reported quality of life outcomes, and one poster presentation on the expanded efficacy and safety data in adult patients.

Vitrakvi was approved by the U.S. Food and Drug Administration (FDA) in November 2018 as the first and only TRK inhibitor exclusively designed for the treatment of adult and pediatric cancer patients with solid tumors with an NTRK gene fusion without a known acquired resistance mutation that are either metastatic or where surgical resection will likely result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment. In the U.S., Vitrakvi was approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Following the acquisition of Loxo Oncology by Eli Lilly and Company in February 2019, Bayer has obtained the exclusive licensing rights for the global development and commercialization, including in the U.S., for Vitrakvi and the investigational TRK inhibitor BAY 2731954 (previously LOXO-195) progressing through clinical development.

In another oral presentation, new data evaluating the impact of darolutamide on time to pain progression and quality of life outcomes in non-metastatic castration-resistant prostate cancer (nmCRPC) patients from the Phase III ARAMIS trial will be presented. The U.S. FDA granted Priority Review and accepted the New Drug Application (NDA) for darolutamide for the treatment of nmCRPC in April 2019. Additionally, Bayer has filed for approval in the European Union (EU) as well as Japan and is also in discussions with other health authorities regarding submissions. Darolutamide, an investigational, non-steroidal androgen receptor (AR) antagonist with a distinct chemical structure, is being developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company.

One of Bayer’s promising early pipeline projects, an investigational oral ATR inhibitor BAY 1895344, will be featured in an oral presentation discussing results of the first-in-human trial for the compound in patients with advanced solid tumors carrying certain DNA damage response (DDR) defects. The DDR is thought to protect cells from DNA damage and mediates cellular response to endogenous or exogenous stress, with ATR kinase being a key regulator in the DDR network in response to replication stress.1,2 Many cancers harbor certain DDR defects making them potentially more vulnerable to inhibition of DNA repair pathways such as ATR.3

Additional presentations include data from Bayer’s approved and pipeline therapies, including real world data for Xofigo® (radium Ra 223 dichloride) in patients with metastatic castration-resistant prostate cancer (mCRPC), long-term follow-up data in patients with relapsed or refractory follicular lymphoma (FL) treated with AliqopaTM (copanlisib) and health-related quality of life (HRQoL) data from the REGOMA trial in relapsed glioblastoma patients treated with Stivarga® (regorafenib).

Following is a list of notable oral and poster presentations at ASCO 2019:

Larotrectinib

Larotrectinib efficacy and safety in adult TRK fusion cancer patients

Poster Presentation #3122, Session: Developmental Therapeutics and Tumor Biology (Nonimmuno)

Saturday, June 1, 8:00 AM – 11:00 AM CDT, Room: Hall A

Patient-reported outcomes from two global multicenter clinical trials of children and adults with tropomyosin receptor kinase (TRK) fusion cancer receiving larotrectinib

Poster Presentation #6602, Session: Health Services Research, Clinical Informatics, and Quality of Care

Saturday, June 1, 1:15 PM – 4:15 PM CDT, Room: Hall A

Larotrectinib efficacy and safety in pediatric TRK fusion cancer patients

Oral Presentation #10010, Session: Pediatric Oncology II

Sunday, June 2, 8:12 AM – 8:24 AM CDT, Room: S504

Activity of larotrectinib in TRK fusion cancer patients with brain metastases or primary central nervous system tumors

Oral Presentation #2006, Session: Central Nervous System Tumors

Monday, June 3, 3:15 PM – 3:27 PM CDT, Room: S102

Darolutamide

Impact of darolutamide (DARO) on pain and quality of life (QoL) in patients (Pts) with nonmetastatic castrate-resistant prostate cancer (nmCRPC)

Oral Presentation #5000, Session: Genitourinary (Prostate) Cancer

Friday, May 31, 2:45 PM – 2:57 PM CDT, Room: Arie Crown Theater

Radium-223 Dichloride (radium-223)

Concurrent or layered treatment with radium-223 (Ra-223) and enzalutamide (Enza) or abiraterone plus prednisone/prednisolone (Abi/pred): A retrospective study of real-world clinical outcomes in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC)

Poster Presentation #5026, Session: Genitourinary (Prostate) Cancer

Saturday, June 1, 1:15 PM – 4:15 PM CDT, Room: Hall A

Regorafenib

Regorafenib plus nivolumab in patients with advanced gastric (GC) or colorectal cancer (CRC): An open-label, dose-finding, and dose-expansion phase 1b trial (REGONIVO, EPOC1603)

Poster Discussion #2522, Session: Developmental Immunotherapy and Tumor Immunobiology

Saturday, June 1, 1:15 PM – 2:45 PM CDT, Room: Hall D1

A double-blind placebo-controlled randomized phase II trial assessing the activity and safety of regorafenib (REG) in patients (pts) with nonadipocytic soft tissue sarcoma (STS) previously treated with pazopanib (PAZ)

Poster Discussion #11021, Session: Sarcoma

Saturday, June 1, 3:00 PM – 4:30 PM CDT, Room: S404

ALT-GIST: Randomised phase II trial of imatinib alternating with regorafenib versus imatinib alone for the first-line treatment of metastatic gastrointestinal stromal tumor (GIST)

Poster Discussion #11023, Session: Sarcoma

Saturday, June 1, 3:00 PM – 4:30 PM CDT, Room: S404

Accumulation of active metabolite M-2 predicts overall survival (OS) of chemorefractory metastatic colorectal cancer patients treated with regorafenib (REGO)

Poster Presentation #3121, Session: Developmental Therapeutics and Tumor Biology (Nonimmuno)

Saturday, June 1, 8:00 AM – 11:00 AM CDT, Room: Hall A

Evaluation of the multi-kinase inhibitor regorafenib in the Pediatric Preclinical Testing Consortium osteosarcoma, rhabdomyosarcoma, and Ewing sarcoma in vivo models

Poster Presentation #10038, Session: Pediatric Oncology

Saturday, June 1, 8:00 AM – 11:00 AM CDT, Room: Hall A

Health-related quality of life (HRQoL) evaluation in the REGOMA trial: A randomized, phase II clinical trial analyzing regorafenib activity in relapsed glioblastoma patients

Poster Presentation #2045, Session: Central Nervous System Tumors

Sunday, June 2, 8:00 AM – 11:00 AM CDT, Room: Hall A

Final analysis of phase II trial of regorafenib (REG) in refractory advanced biliary cancers (BC)

Poster Presentation #4083, Session: Gastrointestinal (Noncolorectal) Cancer

Monday, June 3, 8:00 AM – 11:00 AM CDT, Room: Hall A

Preemptive versus reactive topical clobetasol for regorafenib-induced hand-foot reactions: Results from the ReDOS trial

Poster Presentation #11586, Session: Symptoms and Survivorship

Monday, June 3, 1:15 PM – 4:15 PM CDT, Room: Hall A

Sorafenib

Effect of intensification of induction II chemotherapy and liberalization of stem cell donor source on outcome for children with high risk acute myeloid leukemia: A report from the Children’s Oncology Group

Oral Presentation #10002, Session: Pediatric Oncology I

Friday, May 31, 3:33 PM – 3:45 PM CDT, Room: S504

Copanlisib

Long-term follow-up of patients (pts) with relapsed or refractory (r/r) follicular lymphoma (FL) treated with copanlisib

Poster Presentation #7553, Session: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia

Monday, June 3, 8:00 AM – 11:00 AM CDT, Room: Hall A

Preclinical efficacy of copanlisib in cetuximab sensitive and resistant tumors of HNSCC

Poster Presentation #6031, Session: Head and Neck Cancer

Saturday, June 1, 1:15 PM – 4:15 PM CDT, Room: Hall A

BAY 1895344

First-in-human trial of the oral ataxia telangiectasia and Rad3-related (ATR) inhibitor BAY 1895344 in patients (pts) with advanced solid tumors

Oral Presentation #3007, Session: Developmental Therapeutics and Tumor Biology (Nonimmuno)

Monday, June 3, 10:12 AM – 10:24 AM CDT, Room: S406

Medical Education (non-CME)

ASCO Direct GU: A multistakeholder blended-learning project to make global education local

Poster Presentation #10515, Session: Educational Research and Professional Development

Saturday, June 1, 1:15 PM – 4:15 PM CDT, Room: Hall A

About Darolutamide Darolutamide is an investigational, non-steroidal androgen receptor (AR) antagonist with a distinct chemical structure that binds to the receptor and exhibits antagonistic activity, thereby it is thought to inhibit the receptor function and the growth of prostate cancer cells. A Phase III study in metastatic hormone-sensitive prostate cancer (ARASENS) is ongoing. Information about these trials can be found at www.clinicaltrials.gov. 

Darolutamide is not approved by the U.S. FDA, the European Medicines Agency or any other health authority.

About Vitrakvi® (larotrectinib)  Vitrakvi® is indicated for the treatment of adult and pediatric patients with solid tumors that have an NTRK gene fusion without a known acquired resistance mutation that are either metastatic or where surgical resection will likely result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment.4 This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Research suggests that the NTRK gene can become abnormally fused to other genes, producing a TRK fusion protein that can act as an oncogenic driver, promoting cell growth and survival in tumor cell lines.4

Important Safety Information for VITRAKVI® (larotrectinib)

Neurotoxicity: Among the 176 patients who received VITRAKVI, neurologic adverse reactions of any grade occurred in 53% of patients, including Grade 3 and Grade 4 neurologic adverse reactions in 6% and 0.6% of patients, respectively. The majority (65%) of neurological adverse reactions occurred within the first three months of treatment (range 1 day to 2.2 years). Grade 3 neurologic adverse reactions included delirium (2%), dysarthria (1%), dizziness (1%), gait disturbance (1%), and paresthesia (1%). Grade 4 encephalopathy (0.6%) occurred in a single patient. Neurologic adverse reactions leading to dose modification included dizziness (3%), gait disturbance (1%), delirium (1%), memory impairment (1%), and tremor (1%).4

Advise patients and caretakers of these risks with VITRAKVI. Advise patients not to drive or operate hazardous machinery if they are experiencing neurologic adverse reactions. Withhold or permanently discontinue VITRAKVI based on the severity. If withheld, modify the VITRAKVI dose when resumed.4

Hepatotoxicity: Among the 176 patients who received VITRAKVI, increased transaminases of any grade occurred in 45%, including Grade 3 increased AST or ALT in 6% of patients. One patient (0.6%) experienced Grade 4 increased ALT. The median time to onset of increased AST was 2 months (range: 1 month to 2.6 years). The median time to onset of increased ALT was 2 months (range: 1 month to 1.1 years). Increased AST and ALT leading to dose modifications occurred in 4% and 6% of patients, respectively. Increased AST or ALT led to permanent discontinuation in 2% of patients.4

Monitor liver tests, including ALT and AST, every 2 weeks during the first month of treatment, then monthly thereafter, and as clinically indicated. Withhold or permanently discontinue VITRAKVI based on the severity. If withheld, modify the VITRAKVI dosage when resumed.4

Embryo-Fetal Toxicity: VITRAKVI can cause fetal harm when administered to a pregnant woman. Larotrectinib resulted in malformations in rats and rabbits at maternal exposures that were approximately 11- and 0.7-times, respectively, those observed at the clinical dose of 100 mg twice daily.4

Advise women of the potential risk to a fetus. Advise females of reproductive potential to use an effective method of contraception during treatment and for 1 week after the final dose of VITRAKVI.4

Most Common Adverse Reactions (≥20%): The most common adverse reactions (≥20%) were: increased ALT (45%), increased AST (45%), anemia (42%), fatigue (37%), nausea (29%), dizziness (28%), cough (26%), vomiting (26%), constipation (23%), and diarrhea (22%).4 

Drug Interactions: Avoid coadministration of VITRAKVI with strong CYP3A4 inhibitors (including grapefruit or grapefruit juice), strong CYP3A4 inducers (including St. John’s wort), or sensitive CYP3A4 substrates. If coadministration of strong CYP3A4 inhibitors or inducers cannot be avoided, modify the VITRAKVI dose as recommended. If coadministration of sensitive CYP3A4 substrates cannot be avoided, monitor patients for increased adverse reactions of these drugs.4

Lactation: Advise women not to breastfeed during treatment with VITRAKVI and for 1 week after the final dose.4

Please see the full Prescribing Information for VITRAKVI® (larotrectinib).

About Xofigo® (radium Ra 223 dichloride) Injection5 Xofigo is indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease.

Important Safety Information for Xofigo® (radium Ra 223 dichloride) Injection Contraindications: Xofigo® is contraindicated in women who are or may become pregnant. Xofigo can cause fetal harm when administered to a pregnant woman

Warnings and Precautions:

Administration and Radiation Protection: Xofigo should be received, used, and administered only by authorized persons in designated clinical settings. The administration of Xofigo is associated with potential risks to other persons from radiation or contamination from spills of bodily fluids such as urine, feces, or vomit. Therefore, radiation protection precautions must be taken in accordance with national and local regulations

Fluid Status: Dehydration occurred in 3% of patients on Xofigo and 1% of patients on placebo. Xofigo increases adverse reactions such as diarrhea, nausea, and vomiting, which may result in dehydration. Monitor patients’ oral intake and fluid status carefully and promptly treat patients who display signs or symptoms of dehydration or hypovolemia

Injection Site Reactions: Erythema, pain, and edema at the injection site were reported in 1% of patients on Xofigo

Secondary Malignant Neoplasms: Xofigo contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure may be associated with an increased risk of cancer and hereditary defects. Due to its mechanism of action and neoplastic changes, including osteosarcomas, in rats following administration of radium-223 dichloride, Xofigo may increase the risk of osteosarcoma or other secondary malignant neoplasms. However, the overall incidence of new malignancies in the randomized trial was lower on the Xofigo arm compared to placebo (<1% vs 2%; respectively), but the expected latency period for the development of secondary malignancies exceeds the duration of follow-up for patients on the trial

Subsequent Treatment With Cytotoxic Chemotherapy: In the randomized clinical trial, 16% of patients in the Xofigo group and 18% of patients in the placebo group received cytotoxic chemotherapy after completion of study treatments. Adequate safety monitoring and laboratory testing was not performed to assess how patients treated with Xofigo will tolerate subsequent cytotoxic chemotherapy

Adverse Reactions: The most common adverse reactions (��10%) in the Xofigo arm vs the placebo arm, respectively, were nausea (36% vs 35%), diarrhea (25% vs 15%), vomiting (19% vs 14%), and peripheral edema (13% vs 10%). Grade 3 and 4 adverse events were reported in 57% of Xofigo-treated patients and 63% of placebo-treated patients. The most common hematologic laboratory abnormalities in the Xofigo arm (≥10%) vs the placebo arm, respectively, were anemia (93% vs 88%), lymphocytopenia (72% vs 53%), leukopenia (35% vs 10%), thrombocytopenia (31% vs 22%), and neutropenia (18% vs 5%)

Please see the full Prescribing Information for Xofigo (radium Ra 223 dichloride).

About AliqopaTM (copanlisib) Injection6 Aliqopa (copanlisib) is indicated for the treatment of adult patients with relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies.

Accelerated approval was granted for this indication based on overall response rate. Continued approval for this indication may be contigent upon verification and description of clinical benefit in a confirmatory trial.

Aliqopa is an inhibitor of phosphatidylinositol-3-kinase (PI3K) with inhibitory activity predominantly against PI3K-α and PI3K-δ isoforms expressed in malignant B cells. Aliqopa has been shown to induce tumor cell death by apoptosis and inhibition of proliferation of primary malignant B cell lines. Aliqopa inhibits several key cell-signaling pathways, including B-cell receptor signaling, CXCR12 mediated chemotaxis of malignant B cells, and NFκB signaling in lymphoma cell lines.

The broad clinical development program for copanlisib also includes ongoing Phase III studies in indolent NHL (iNHL) patients who have relapsed or are refractory to prior therapies. The CHRONOS-3 Phase III study is evaluating copanlisib in combination with rituximab in relapsed iNHL and the CHRONOS-4 Phase III study is evaluating copanlisib in combination with standard immunochemotherapy in relapsed iNHL. More information about these trials can be found at www.clinicaltrials.gov.

Important Safety Information for Aliqopa (copanlisib) Injection

Infections: Serious, including fatal, infections occurred in 19% of 317 patients treated with ALIQOPA monotherapy. The most common serious infection was pneumonia. Monitor patients for signs and symptoms of infection and withhold ALIQOPA for Grade 3 and higher infection.

Serious pneumocystis jiroveci pneumonia (PJP) infection occurred in 0.6% of 317 patients treated with ALIQOPA monotherapy. Before initiating treatment with ALIQOPA, consider PJP prophylaxis for populations at risk.  Withhold ALIQOPA in patients with suspected PJP infection of any grade. If confirmed, treat infection until resolution, then resume ALIQOPA at previous dose with concomitant PJP prophylaxis.

Hyperglycemia: Grade 3 or 4 hyperglycemia (blood glucose 250 mg/dL or greater) occurred in 41% of 317 patients treated with ALIQOPA monotherapy. Serious hyperglycemic events occurred in 2.8% of patients. Treatment with ALIQOPA may result in infusion-related hyperglycemia. Blood glucose levels typically peaked 5 to 8 hours post-infusion and subsequently declined to baseline levels for a majority of patients; blood glucose levels remained elevated in 17.7% of patients one day after ALIQOPA infusion. Of 155 patients with baseline HbA1c <5.7%, 16 (10%) patients had HbA1c >6.5% at the end of treatment.

Of the twenty patients with diabetes mellitus treated in CHRONOS-1, seven developed Grade 4 hyperglycemia and two discontinued treatment. Patients with diabetes mellitus should only be treated with ALIQOPA following adequate glucose control and should be monitored closely. Withhold, reduce dose, or discontinue ALIQOPA depending on the severity and persistence of hyperglycemia.

Achieve optimal blood glucose control before starting each ALIQOPA infusion. Withhold, reduce dose, or discontinue ALIQOPA depending on the severity and persistence of hyperglycemia.

Hypertension: Grade 3 hypertension (systolic 160 mmHg or greater or diastolic 100 mmHg or greater) occurred in 26% of 317 patients treated with ALIQOPA monotherapy. Serious hypertensive events occurred in 0.9% of 317 patients. Treatment with ALIQOPA may result in infusion-related hypertension. The mean change of systolic and diastolic BP from baseline to 2 hours post-infusion on Cycle 1 Day 1 was 16.8 mmHg and 7.8 mmHg, respectively. The mean BP started decreasing approximately 2 hours post-infusion; BP remained elevated for 6 to 8 hours after the start of the ALIQOPA infusion. Optimal BP control should be achieved before starting each ALIQOPA infusion. Monitor BP pre- and post-infusion. Withhold, reduce dose, or discontinue ALIQOPA depending on the severity and persistence of hypertension.

Non-infectious Pneumonitis: Non-infectious pneumonitis occurred in 5% of 317 patients treated with ALIQOPA monotherapy. Withhold ALIQOPA and conduct a diagnostic examination of a patient who is experiencing pulmonary symptoms such as cough, dyspnea, hypoxia, or interstitial infiltrates on radiologic exam. Patients with pneumonitis thought to be caused by ALIQOPA have been managed by withholding ALIQOPA and administration of systemic corticosteroids. Withhold, reduce dose, or discontinue ALIQOPA depending on the severity and persistence of non-infectious pneumonitis.

Neutropenia: Grade 3 or 4 neutropenia occurred in 24% of 317 patients treated with ALIQOPA monotherapy. Serious neutropenic events occurred in 1.3%. Monitor blood counts at least weekly during treatment with ALIQOPA. Withhold, reduce dose, or discontinue ALIQOPA depending on the severity and persistence of neutropenia.

Severe Cutaneous Reaction: Grade 3 and 4 cutaneous reactions occurred in 2.8% and 0.6% of 317 patients treated with ALIQOPA monotherapy respectively. Serious cutaneous reaction events were reported in 0.9%. The reported events included dermatitis exfoliative, exfoliative rash, pruritus, and rash (including maculo-papular rash). Withhold, reduce dose, or discontinue ALIQOPA depending on the severity and persistence of severe cutaneous reactions.

Embryo-Fetal Toxicity: Based on findings in animals and its mechanism of action, ALIQOPA can cause fetal harm when administered to a pregnant woman. In animal reproduction studies, administration of copanlisib to pregnant rats during organogenesis caused embryo-fetal death and fetal abnormalities in rats at maternal doses as low as 0.75 mg/kg/day (4.5 mg/m2/day body surface area) corresponding to approximately 12% the recommended dose for patients. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception during treatment and for at least one month after the last dose.

Adverse Drug Reactions: Serious adverse reactions were reported in 44 (26%) patients. The most frequent serious adverse reactions that occurred were pneumonia (8%), pneumonitis (5%) and hyperglycemia (5%). Adverse reactions resulted in dose reduction in 36 (21%) and discontinuation in 27 (16%) patients. The most frequently observed adverse drug reactions (≥20%) in ALIQOPA-treated patients were: hyperglycemia (54%), leukopenia (36%), diarrhea (36%), decreased general strength and energy (36%), hypertension (35%), neutropenia (32%), nausea (26%), thrombocytopenia (22%), and lower respiratory tract infections (21%).

Drug Interactions: Avoid concomitant use with strong CYP3A inducers. Reduce the ALIQOPA dose to 45 mg when concomitantly administered with strong CYP3A inhibitors.

Lactation: Advise women not to breastfeed. Advise a lactating woman not to breastfeed during treatment with ALIQOPA and for at least 1 month after the last dose.

Please see the full Prescribing Information of Aliqopa (copanlisib) Injection.

About Stivarga® (regorafenib)7 In April 2017, Stivarga was approved for use in patients with hepatocellular carcinoma who have been previously treated with Nexavar® (sorafenib). In the United States, Stivarga is also indicated for the treatment of patients with metastatic colorectal cancer (CRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type, an anti-EGFR therapy. It is also indicated for the treatment of patients with locally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST) who have been previously treated with imatinib mesylate and sunitinib malate.

Regorafenib is a compound developed by Bayer. In 2011, Bayer entered into an agreement with Onyx, now an Amgen subsidiary, under which Onyx receives a royalty on all global net sales of regorafenib in oncology.

Important Safety Information for Stivarga

WARNING: HEPATOTOXICITY

• Severe and sometimes fatal hepatotoxicity has occurred in clinical trials. • Monitor hepatic function prior to and during treatment. • Interrupt and then reduce or discontinue STIVARGA for hepatotoxicity as manifested by elevated liver function tests or hepatocellular necrosis, depending upon severity and persistence.

Hepatotoxicity: Severe drug-induced liver injury with fatal outcome occurred in STIVARGA-treated patients across all clinical trials. In most cases, liver dysfunction occurred within the first 2 months of therapy and was characterized by a hepatocellular pattern of injury. In metastatic colorectal cancer (mCRC), fatal hepatic failure occurred in 1.6% of patients in the STIVARGA arm and in 0.4% of patients in the placebo arm. In gastrointestinal stromal tumor (GIST), fatal hepatic failure occurred in 0.8% of patients in the STIVARGA arm. In hepatocellular carcinoma (HCC), there was no increase in the incidence of fatal hepatic failure as compared to placebo.

Liver Function Monitoring: Obtain liver function tests (ALT, AST, and bilirubin) before initiation of STIVARGA and monitor at least every 2 weeks during the first 2 months of treatment. Thereafter, monitor monthly or more frequently as clinically indicated. Monitor liver function tests weekly in patients experiencing elevated liver function tests until improvement to less than 3 times the upper limit of normal (ULN) or baseline values. Temporarily hold and then reduce or permanently discontinue STIVARGA, depending on the severity and persistence of hepatotoxicity as manifested by elevated liver function tests or hepatocellular necrosis.

Infections: STIVARGA caused an increased risk of infections. The overall incidence of infection (Grades 1-5) was higher (32% vs 17%) in 1142 STIVARGA-treated patients as compared to the control arm in randomized placebo-controlled trials. The incidence of grade 3 or greater infections in STIVARGA treated patients was 9%. The most common infections were urinary tract infections (5.7%), nasopharyngitis (4.0%), mucocutaneous and systemic fungal infections (3.3%) and pneumonia (2.6%). Fatal outcomes caused by infection occurred more often in patients treated with STIVARGA (1.0%) as compared to patients receiving placebo (0.3%); the most common fatal infections were respiratory (0.6% vs 0.2%). Withhold STIVARGA for Grade 3 or 4 infections, or worsening infection of any grade. Resume STIVARGA at the same dose following resolution of infection.

Hemorrhage: STIVARGA caused an increased incidence of hemorrhage. The overall incidence (Grades 1-5) was 18.2% in 1142 patients treated with STIVARGA vs 9.5% with placebo in randomized, placebo-controlled trials. The incidence of grade 3 or greater hemorrhage in patients treated with STIVARGA was 3.0%. The incidence of fatal hemorrhagic events was 0.7%, involving the central nervous system or the respiratory, gastrointestinal, or genitourinary tracts. Permanently discontinue STIVARGA in patients with severe or life-threatening hemorrhage and monitor INR levels more frequently in patients receiving warfarin.

Gastrointestinal Perforation or Fistula: Gastrointestinal perforation occurred in 0.6% of 4518 patients treated with STIVARGA across all clinical trials of STIVARGA administered as a single agent; this included eight fatal events. Gastrointestinal fistula occurred in 0.8% of patients treated with STIVARGA and in 0.2% of patients in the placebo arm across randomized, placebo-controlled trials. Permanently discontinue STIVARGA in patients who develop gastrointestinal perforation or fistula.

Dermatological Toxicity: In randomized, placebo-controlled trials, adverse skin reactions occurred in 71.9% of patients with STIVARGA arm and 25.5% of patients in the placebo arm including hand-foot skin reaction (HFSR) also known as palmar-plantar erythrodysesthesia syndrome (PPES) and severe rash, requiring dose modification. In the randomized, placebo-controlled trials, the overall incidence of HFSR was higher in 1142 STIVARGA-treated patients (53% vs 8%) than in the placebo-treated patients. Most cases of HFSR in STIVARGA-treated patients appeared during the first cycle of treatment. The incidences of Grade 3 HFSR (16% vs <1%), Grade 3 rash (3% vs <1%), serious adverse reactions of erythema multiforme (<0.1% vs 0%), and Stevens-Johnson syndrome (<0.1% vs 0%) were higher in STIVARGA-treated patients. Across all trials, a higher incidence of HFSR was observed in Asian patients treated with STIVARGA (all grades: 72%; Grade 3:18%). Toxic epidermal necrolysis occurred in 0.02% of 4518 STIVARGA-treated patients across all clinical trials of STIVARGA administered as a single agent. Withhold STIVARGA, reduce the dose, or permanently discontinue depending on the severity and persistence of dermatologic toxicity.

Hypertension: Hypertensive crisis occurred in 0.2% in STIVARGA-treated patients and in none of the patients in placebo arm across all randomized, placebo-controlled trials. STIVARGA caused an increased incidence of hypertension (30% vs 8% in mCRC, 59% vs 27% in GIST, and 31% vs 6% in HCC). The onset of hypertension occurred during the first cycle of treatment in most patients who developed hypertension (67% in randomized, placebo-controlled trials). Do not initiate STIVARGA until blood pressure is adequately controlled. Monitor blood pressure weekly for the first 6 weeks of treatment and then every cycle, or more frequently, as clinically indicated. Temporarily or permanently withhold STIVARGA for severe or uncontrolled hypertension.

Cardiac Ischemia and Infarction: STIVARGA increased the incidence of myocardial ischemia and infarction (0.9% with STIVARGA vs 0.2% with placebo) in randomized placebo-controlled trials. Withhold STIVARGA in patients who develop new or acute cardiac ischemia or infarction, and resume only after resolution of acute cardiac ischemic events if the potential benefits outweigh the risks of further cardiac ischemia.

Reversible Posterior Leukoencephalopathy Syndrome (RPLS): Reversible posterior leukoencephalopathy syndrome (RPLS), a syndrome of subcortial vasogenic edema diagnosed by characteristic finding on MRI occurred in one of 4800 STIVARGA-treated patients across all clinical trials. Perform an evaluation for RPLS in any patient presenting with seizures, severe headache, visual disturbances, confusion, or altered mental function. Discontinue STIVARGA in patients who develop RPLS.

Wound Healing Complications: Treatment with STIVARGA should be stopped at least 2 weeks prior to scheduled surgery. Resuming treatment after surgery should be based on clinical judgment of adequate wound healing. STIVARGA should be discontinued in patients with wound dehiscence.

Embryo-Fetal Toxicity: STIVARGA can cause fetal harm when administered to a pregnant woman. There are no available data on STIVARGA use in pregnant women. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception during treatment with STIVARGA and for 2 months after the final dose.

Nursing Mothers: Because of the potential for serious adverse reactions in breastfed infants from STIVARGA, do not breastfeed during treatment with STIVARGA and for 2 weeks after the final dose.

Most Frequently Observed Adverse Drug Reactions in mCRC (≥30%): The most frequently observed adverse drug reactions (≥30%) in STIVARGA-treated patients vs placebo-treated patients in mCRC, respectively, were: asthenia/fatigue (64% vs 46%), pain (59% vs 48%), decreased appetite and food intake (47% vs 28%), HFSR/PPE (45% vs 7%), diarrhea (43% vs 17%), mucositis (33% vs 5%), weight loss (32% vs 10%), infection (31% vs 17%), hypertension (30% vs 8%), and dysphonia (30% vs 6%).

Most Frequently Observed Adverse Drug Reactions in GIST (≥30%): The most frequently observed adverse drug reactions (≥30%) in STIVARGA-treated patients vs placebo-treated patients in GIST, respectively, were: HFSR/PPE (67% vs 12%), pain (60% vs 55%), hypertension (59% vs 27%), asthenia/fatigue (52% vs 39%), diarrhea (47% vs 9%), mucositis (40% vs 8%), dysphonia (39% vs 9%), infection (32% vs 5%), decreased appetite and food intake (31% vs 21%), and rash (30% vs 3%).

Most Frequently Observed Adverse Drug Reactions in HCC (≥30%): The most frequently observed adverse drug reactions (≥30%) in STIVARGA-treated patients vs placebo-treated patients in HCC, respectively, were: pain (55% vs 44%), HFSR/PPE (51% vs 7%), asthenia/fatigue (42% vs 33%), diarrhea (41% vs 15%), hypertension (31% vs 6%), infection (31% vs 18%), decreased appetite and food intake (31% vs 15%).

Please see full Prescribing Information, including Boxed Warning for Stivarga (regorafenib).

About NEXAVAR® (sorafenib) Tablets8 NEXAVAR is approved in the U.S. for the treatment of patients with unresectable hepatocellular carcinoma, patients with advanced renal cell carcinoma and patients with locally recurrent or metastatic, progressive, differentiated thyroid carcinoma refractory to radioactive iodine treatment.8

Important Safety Information For NEXAVAR® (sorafenib) Tablets

Contraindications: NEXAVAR is contraindicated in patients with known severe hypersensitivity to sorafenib or any other component of NEXAVAR.

NEXAVAR in combination with carboplatin and paclitaxel is contraindicated in patients with squamous cell lung cancer.

Cardiovascular Events: In the SHARP (HCC) study, the incidence of cardiac ischemia/infarction was 2.7% in NEXAVAR-treated patients compared with 1.3% for placebo-treated group.  In the TARGET (RCC) study, the incidence of cardiac ischemia/infarction was higher in the NEXAVAR-treated group (2.9%) compared with the placebo-treated group (0.4%). In the DECISION (DTC) study, the incidence of cardiac ischemia/infarction was 1.9% in the NEXAVAR-treated group compared with 0% in the placebo-treated group. Patients with unstable coronary artery disease or recent myocardial infarction were excluded from this study. Temporary or permanent discontinuation of NEXAVAR should be considered in patients who develop cardiovascular events.

Hemorrhage:  An increased risk of bleeding may occur following NEXAVAR administration. In the SHARP (HCC) study, the following bleeding adverse reactions were reported in the NEXAVAR-treated vs. placebo-treated patients, respectively: bleeding from esophageal varices (2.4% vs. 4%) and bleeding with fatal outcome at any site (2.4% vs. 4%).  In the TARGET (RCC) study, bleeding regardless of causality was reported in 15.3% of patients in the NEXAVAR-treated group and 8.2% of patients in the placebo-treated group. The incidence of CTCAE Grade 3 and 4 bleeding was 2% and 0%, respectively, in NEXAVAR-treated patients, and 1.3% and 0.2%, respectively, in placebo-treated patients. There was one fatal hemorrhage in each treatment group in the TARGET (RCC) study. In the DECISION (DTC) study, bleeding was reported in 17.4% of NEXAVAR-treated patients and 9.6% of placebo-treated patients; however, the incidence of CTCAE Grade 3 bleeding was 1% in NEXAVAR-treated patients and 1.4% in placebo-treated patients. There was no Grade 4 bleeding reported and there was one fatal hemorrhage in a placebo-treated patient.  If any bleeding necessitates medical intervention, permanent discontinuation of NEXAVAR should be considered.

Hypertension:  Monitor blood pressure weekly during the first 6 weeks and periodically thereafter, and treat, if required. In the SHARP (HCC) study, hypertension was reported in 9.4% of NEXAVAR-treated patients and 4.3% of patients in the placebo-treated group. In the TARGET (RCC) study, hypertension was reported in 16.9% of NEXAVAR-treated patients and 1.8% of patients in the placebo-treated group. In the DECISION (DTC) study, hypertension was reported in 40.6% of NEXAVAR-treated patients and 12.4% of placebo-treated patients. Hypertension was usually mild to moderate, occurred early in the course of treatment, and was managed with standard antihypertensive therapy. In cases of severe or persistent hypertension despite institution of antihypertensive therapy, consider temporary or permanent discontinuation of NEXAVAR.

Dermatologic Toxicities:  Hand-foot skin reaction and rash are the most common adverse reactions attributed to NEXAVAR. Management of dermatologic toxicities may include topical therapies for symptomatic relief, temporary treatment interruption and/or dose modification of NEXAVAR, or in severe or persistent cases, permanent discontinuation of NEXAVAR. There have been reports of severe dermatologic toxicities, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). These cases may be life-threatening. Discontinue NEXAVAR if SJS or TEN are suspected.

Gastrointestinal Perforation:  Gastrointestinal perforation was an uncommon adverse reaction and has been reported in less than 1% of patients taking NEXAVAR. Permanently discontinue NEXAVAR in the event of a gastrointestinal perforation.

Warfarin:  Infrequent bleeding or elevations in the International Normalized Ratio (INR) have been reported in some patients taking warfarin while on NEXAVAR. Monitor patients taking concomitant warfarin regularly for changes in prothrombin time (PT), INR, or clinical bleeding episodes.

Wound Healing Complications:  Temporary interruption of NEXAVAR therapy is recommended in patients undergoing major surgical procedures. 

Increased Mortality, Concomitant Administration with Carboplatin/Paclitaxel & Gemcitabine/Cisplatin in Squamous Cell Lung Cancer:  In a subset analysis of two randomized controlled trials in chemo-naïve patients with Stage IIIB-IV non-small cell lung cancer, patients with squamous cell carcinoma experienced higher mortality with the addition of NEXAVAR compared to those treated with carboplatin/paclitaxel alone (HR 1.81, 95% CI 1.19–2.74) and gemcitabine/cisplatin alone (HR 1.22, 95% CI 0.82-1.80). NEXAVAR, in combination with gemcitabine/cisplatin, is not recommended in patients with squamous cell lung cancer. The safety and effectiveness of NEXAVAR has not been established in patients with non-small cell lung cancer.

QT Interval Prolongation: NEXAVAR can prolong the QT/QTc interval.  QT/QTc interval prolongation increases the risk for ventricular arrhythmias. Avoid use in patients with congenital long QT syndrome. Monitor electrolytes and electrocardiograms in patients with congestive heart failure, bradyarrhythmias, drugs known to prolong the QT interval, including Class Ia and III antiarrhythmics. Correct electrolyte abnormalities (magnesium, potassium, calcium). Interrupt NEXAVAR if QTc interval is greater than 500 milliseconds or for an increase from baseline of 60 milliseconds or greater.

Drug-Induced Liver Injury: Sorafenib-induced hepatitis is characterized by a hepatocellular pattern of liver damage with significant increases of transaminases which may result in hepatic failure and death. Increases in bilirubin and INR may also occur. Liver function tests should be monitored regularly and in cases of increased transaminases without alternative explanation NEXAVAR should be discontinued.

Embryo-Fetal Toxicity:  Based on its mechanism of action and findings in animals, NEXAVAR may cause fetal harm when administered to a pregnant woman. Sorafenib caused embryo-fetal toxicities in animals at maternal exposures that were significantly lower than the human exposures at the recommended dose of 400 mg twice daily. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Verify the pregnancy status of females of reproductive potential prior to initiation of NEXAVAR. Advise females of reproductive potential to use effective contraception during treatment and for 6 months following the last dose of NEXAVAR. Advise male patients with female partners of reproductive potential and pregnant partners to use effective contraception during treatment and for 3 months following the last dose of NEXAVAR.

Impairment of Thyroid Stimulating Hormone Suppression in Differentiated Thyroid Carcinoma:  NEXAVAR impairs exogenous thyroid suppression.  In the DECISION (DTC) study, 99% of patients had a baseline thyroid stimulating hormone (TSH) level less than 0.8 mU/L.  Elevation of TSH level above 0.5 mU/L was observed in 41% of NEXAVAR-treated patients as compared with 16% of placebo-treated patients.  For patients with impaired TSH suppression while receiving NEXAVAR, the median maximal TSH was 1.6 mU/L and 25% had TSH levels greater than 4.4mU/L.  Monitor TSH levels monthly and adjust thyroid replacement medication as need in patients with DTC.

Laboratory Abnormalities:  In the HCC study, the most common laboratory abnormalities observed in the NEXAVAR arm versus the placebo arm, respectively, were hypoalbuminemia (59% vs. 47%), lymphopenia (47% vs. 42%), thrombocytopenia (46% vs. 41%), elevation in INR (42% vs. 34%), elevated lipase (40% vs. 37%), hypophosphatemia (35% vs. 11%), elevated amylase (34% vs. 29%), hypocalcemia (27% vs. 15%), and hypokalemia (9.5% vs. 5.9%).

In the RCC study, the most common laboratory abnormalities observed in the NEXAVAR arm versus the placebo arm, respectively, were hypophosphatemia (45% vs. 11%), anemia (44% vs. 49%), elevated lipase (41% vs. 30%), elevated amylase (30% vs. 23%), lymphopenia (23% vs. 13%), neutropenia (18% vs. 10%), thrombocytopenia (12% vs. 5%), hypocalcemia (12% vs. 8%), and hypokalemia (5.4% vs. 0.7%).

In the DTC study, the most common laboratory abnormalities observed in the NEXAVAR arm versus the placebo arm, respectively, were elevated ALT (59% vs. 24%), elevated AST (54% vs. 15%), and hypocalcemia (36% vs. 11%).The relative increase for the following laboratory abnormalities observed in NEXAVAR-treated DTC patients as compared to placebo-treated patients is similar to that observed in the RCC and HCC studies: lipase, amylase, hypokalemia, hypophosphatemia, neutropenia, lymphopenia, anemia, and thrombocytopenia.

Most Frequently Observed Adverse Drug Reactions (≥20%):  The most common adverse reactions reported in ≥20% of patients and at a higher rate in the NEXAVAR arm versus the placebo arm, respectively, in the SHARP (HCC) study included: diarrhea (55% vs. 25%), fatigue (46% vs. 45%), abdominal pain (31% vs. 26%), weight loss (30% vs. 10%), anorexia (29% vs. 18%), nausea (24% vs. 20%), and hand-foot skin reaction (21% vs. 3%). Grade 3/4 adverse reactions were 45% vs. 32%. 

The most common adverse reactions reported in ≥20% of patients and at a higher rate in the NEXAVAR arm versus the placebo arm, respectively, in the TARGET (RCC) study included:  diarrhea (43% vs. 14%), rash/desquamation (40% vs. 16%), fatigue (37% vs. 28%), hand-foot skin reaction (30% vs. 7%), alopecia (27% vs. 3%), and nausea (23% vs. 19%), anorexia (29% vs. 18%), nausea (23% vs. 19%). Grade 3/4 adverse reactions were 38% vs. 28%.

The most common adverse reactions reported in ≥20% of patients and at a higher rate in the NEXAVAR arm versus the placebo arm, respectively, in the DECISION (DTC) study included: palmar-plantar erythrodysesthesia syndrome (PPES) (69% vs. 8%), diarrhea (68% vs. 15%), alopecia (67% vs. 8%), weight loss (49% vs. 14%), fatigue (41% vs. 20%), hypertension (41% vs. 12%), rash (35% vs. 7%), decreased appetite (30% vs. 5%), stomatitis (24% vs. 3%), nausea (21% vs. 12%), pruritus (20% vs. 11%), and abdominal pain (20% vs. 7%). Grade 3/4 adverse reactions were 65% vs 30%.

Drug Interactions:  Avoid concomitant use of strong CYP3A4 inducers, when possible, because inducers can decrease the systemic exposure of sorafenib. NEXAVAR exposure decreases when co-administered with oral neomycin. Effects of other antibiotics on NEXAVAR pharmacokinetics have not been studied.

Lactation: Because of the potential for serious adverse reactions in a breastfed child from NEXAVAR, advise lactating women not to breastfeed during treatment with NEXAVAR and for 2 weeks after the last dose.

For full prescribing information, visit http://labeling.bayerhealthcare.com/html/products/pi/Nexavar_PI.pdf.

About Oncology at Bayer Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The oncology franchise at Bayer includes five marketed products and several other assets in various stages of clinical development. Together, these products reflect the company’s approach to research, which prioritizes targets and pathways with the potential to impact the way that cancer is treated.

About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to benefit people by supporting efforts to overcome the major challenges presented by a growing and aging global population. At the same time, the Group aims to increase its earning power and create value through innovation and growth. Bayer is committed to the principles of sustainable development, and the Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2018, the Group employed around 117,000 people and had sales of 39.6 billion euros. Capital expenditures amounted to 2.6 billion euros, R&D expenses to 5.2 billion euros. For more information, go to www.bayer.us.

###

© 2019 Bayer BAYER, the Bayer Cross, Vitrakvi, Aliqopa, Nexavar, Stivarga and Xofigo are registered trademarks of Bayer.

Media Contact: Rose Talarico, Tel. +1 862.404.5302 E-Mail: rose.talarico@bayer.com

Forward-Looking Statements This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. 

References

Ciccia A, Elledge SJ. The DNA damage response: making it safe to play with knives. Mol Cell 2010;40(2):179-204 doi 10.1016/j.molcel.2010.09.019.

Karnitz LM, Zou L. Molecular Pathways: Targeting ATR in Cancer Therapy. Clin Cancer Res 2015;21(21):4780-5 doi 10.1158/1078-0432.CCR-15-0479.

Jackson, Stephen P, et al. The DNA-damage response in human biology and disease. Nature 2009; 461:1071–1078. doi: 10.1038/nature08467.

Vitrakvi® (larotrectinib) capsules and solution for oral use [Prescribing Information]. Stamford, CT: Loxo Oncology Inc.; November 2018.

XOFIGO® (radium-223 dichloride) Injection [Prescribing Information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, February 2018.

AliqopaTM (copanlisib) for injection [Prescribing Information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, September 2017.

Stivarga® (Regorafenib) tablets [Prescribing Information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, April 2017

NEXAVAR® (sorafenib) [Prescribing Information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, December 2018.

PP-PF-ONC-US-0562-1                                                                                               05/19

Intended for U.S. Media Only

SOURCE Bayer

Related Links

http://www.bayer.us

The post Bayer Data at ASCO 2019 Highlights Commitment to Evolving the Cancer Treatment Paradigm appeared first on The Chestnut Post.

from The Chestnut Post https://www.thechestnutpost.com/news/bayer-data-at-asco-2019-highlights-commitment-to-evolving-the-cancer-treatment-paradigm/

[titheguerrero]

Make Asbestos Great Again? - Trump Once Claimed "Movement Against by Asbestos was Led by the Mob," Now is EPA Wants to Relax Asbestos Regulation

Introduction:  An Old Public Health Menace This is somewhat personal.  In the early 1980s, as a general internal medicine fellow, I gave a series of talks about important medical problems that generalist physicians often missed.  One was asbestos related disease.  Although asbestos had been heavily regulated since 1973, there were stilll large numbers of people exposed to it alive in the 1980s.  One of my primitive slides, seemingly a picture of type writing, stated that around then, 2 to 4 million people who had histories of significant asbestos exposure were likely alive.  Asbestos is known to cause several cancers.  It is likely the nearly exclusive cause of mesothelioma.  It also causes lung cancer, and may act synergistically with smoking, and likely gastrointestinal and head and neck cancer.  It causes asbestosis, which can lead to respiratory failure. In 2018, the evidence that asbestos is a major health hazard is quite clear. (See summaries by The National Cancer Institute, the Agency for Toxic Substances and Disease Registry, the Occupational Safety and Health Adminstration.)  Note that the rates of death from mesothelioma per capita are declining, but still substantial (look here).  The application of asbestos can be very hazardous, but once applied it can still endanger not only those who remove it, but firefighters, other first responders, etc.  People can be exposed indirectly, e.g., from asbestos on the clothes of people who work directly with it.  Unlike other countries, the US never banned asbestos outright.  However, per the NCI report, 

In the late 1970s, the U.S. Consumer Product Safety Commission (CPSC) banned the use of asbestos in wallboard patching compounds and gas fireplaces because the asbestos fibers in these products could be released into the environment during use. In addition, manufacturers of electric hairdryers voluntarily stopped using asbestos in their products in 1979. In 1989, the U.S. Environmental Protection Agency (EPA) banned all new uses of asbestos; however, uses developed before 1989 are still allowed.

Trump Called the Movement Against Asbestos a Plot by Organized Crime As we discussed in 2016, Donald Trump has pooh poohed all that.  Per Mother Jones,

In his 1997 book, The Art of the Comeback, Trump warned America not to buy the crusade against 'the greatest fire-proofing material ever used.' He claimed the movement to remove asbestos—a known carcinogen—was actually the handiwork of the mafia: 'I believe that the movement against asbestos was led by the mob, because it was often mob-related companies that would do the asbestos removal. Great pressure was put on politicians, and as usual, the politicians relented. Millions of truckloads of this incredible fire-proofing material were taken to special 'dump sites' and asbestos was replaced by materials that were supposedly safe but couldn’t hold a candle to asbestos in limiting the ravages of fire.' Trump claimed asbestos is '100 percent safe, once applied,' and that it just 'got a bad rap.'

This year, Rolling Stone revealed,

Trump has also on multiple occasions blamed the collapse of the two World Trade Center towers on the absence of asbestos. In June, All in With Chris Hayes aired a clip of Trump defending the material before Congress in 2005. 'A lot of people say that if the World Trade Center had asbestos is wouldn’t have burned down, it’s wouldn’t have melted. OK?,' he said. 'A lot of people in my industry think asbestos is the greatest fireproofing material ever made.' Trump went on to compare asbestos to a 'heavyweight champion' compared to other building material, which he likened to a 'light-weight from high school.'

The article also stated that

As Hayes notes, Trump’s penchant for asbestos is almost certainly due to the cost of having it removed, which was undoubtedly a nuisance to a man known for stiffing contractors and cutting every regulatory corner imaginable.

Trump's beliefs, not to put too fine a point on it, to be nonsense, albeit somewhat consistent nonsense. In 2016, I wrote,

It is disturbing when one candidate for the most powerful political office in the US repeatedly disregards the best clinical and public health evidence, and offers ill considered opinions about public health that could potentially harm patients.

Now Trump is President, and in a position to act on nonsense. Trump's EPA Appears Ready to Relax Asbestos Regulation This week, the distinguished occupational health journal Rolling Stone reported,

On June 1st, the EPA enacted the Significant New Use Rule, which allows the government to evaluate asbestos use on a case-by-case basis. Around the same time, the EPA released a new framework for how it evaluates chemical risk. Not included in the evaluation process are the potential effects of exposure to chemicals in the air, ground or water. It’s as absurd as it sounds. It is ridiculous,' Wendy Cleland-Hamnett, who recently retired after four decades at the EPA, told the New York Times. 'You can’t determine if there is an unreasonable risk without doing a comprehensive risk evaluation.' The new evaluation framework is a nifty way for the EPA to circumvent an Obama-era law requiring the EPA to evaluate hundreds of potentially dangerous chemicals. Asbestos is among the first batch of 10 chemicals the EPA will examine, and also one of the most blatantly dangerous to public health.

Quartz explained further,

On July 1, the US Environmental Protection Agency issued a 'significant new use rule,' which invites manufacturers to petition the EPA to seek approval of any new asbestos product on a case-by-case basis. The rule says that the EPA will evaluate new asbestos products as 'new use' if they’ve determined they aren’t currently being manufactured. The categories the EPA says it will consider as new uses include 'adhesives, sealants, and roof and non-roof coatings; arc chutes; beater-add gaskets; extruded sealant tape and other tape; filler for acetylene cylinders; high-grade electrical paper; millboard; missile liner; pipeline wrap; reinforced plastics; roofing felt; separators in fuel cells and batteries; vinyl-asbestos floor tile; and any other building material (other than cement).'

Today, the New York Times reported that the EPA's new approach was launched by Trump political appointees over the objections of career, professional staff.

Top officials at the Environmental Protection Agency pushed through a measure to review applications for using asbestos in consumer products, and did so over the objections of E.P.A.’s in-house scientists and attorneys, internal agency emails show.

So it looks like these top officials are trying to operationalize Trump's enthusiasm for asbestos despite the absence of any new evidence that asbestos is less dangerous than previously thought, and despite the suggestion that Trump's enthusiasm may be self-interested. On No, Russians Too Two years ago, it seemed that one could attribute all of Trump's bias against asbestos regulation had to do with his real estate development background.  However, Rolling Stone found another possible influence on him.

As with many of his more insidious actions as president, there’s a Russia connection. As the Washington Post points out, until recently, 95 percent of asbestos used in the United States came from Brazil, while the rest came from Russia. But the South American nation recently banned the mining and sale of the toxic substance, opening the door for Russia to fill the gap, which will be even larger if the U.S. resumes using the carcinogen in building materials. Russian asbestos manufacturers are thrilled. In July, the Russian company Uralasbest posted an image of its asbestos packaging, which features a smirking President Trump.

The NY Times verified that 

the Russian firm Uralasbest posted on Facebook an image of its asbestos packaging that featured President Donald J. Trump’s face along with the words: 'Approved by Donald Trump, 45th president of the United States.' 

So it appears that the push by EPA political appointees to make asbestos regulation lax again would benefit Russia, a country for which Trump seems to feel great affection.  Summary Donald Trump long has had strong opinions on all sorts of topics.  His opinions about the public health hazards of asbestos seemed more informed by his self-interest as a real estate developer than anything resembling clinical or epidemiological evidence.  When he was just a rich real estate developer these seemingly misinformed opinions were of little consequence. Now he is US President and his misinformed decisions could have major consequences, including eventually lethal ones.  Unfortunately, he seems to make such decisions so rapidly that no one can keep up.  And few of the people he has appointed to top leadership positions, particularly in health care and public health, seem inclined to stand up for more logical, evidence-based, and unconflicted and uncorrupted decision making.  Obscure parts of asbestos regulation may not get a lot of attention, and may not be as dangerous as decisions about, say, nuclear weapons, but they still could be quite dangerous.  I hope those who care about medicine, health care, and public health will speak out against any new laxity in asbestos regulation.  In 2016 we had an opportunity to prevent a regime of the conflicted and uninformed.  Now we must challenge its bad decisions more directly.  Musical Interlude The immortal Warren Zevon, Lawyers Guns and Money: "how was I to know she was with the Russians too?" - Live Version

Article source:Health Care Renewal

[reportsandmarkets]

Head And Neck Cancer - Pipeline Review, H1 2018

Head And Neck Cancer – Pipeline Review, H1 2018

  ReportsandMarkets latest Pharmaceutical and Healthcare disease pipeline guide Head And Neck Cancer – Pipeline Review, H1 2018, provides an overview of the Head And Neck Cancer (Oncology) pipeline landscape.

Head and Neck Cancer is a cancer that arises in the head or neck region (in the nasal cavity, sinuses, lips, mouth, salivary glands, throat, or larynx). The common symptoms of cancer of the…

[robertwadia-blog]

HTF Market Intelligence released a new research report of 1247 pages on title ‘Head And Neck Cancer – Pipeline Review, H1 2017’ with detailed analysis, forecast and strategies.

[priya1sharma]

Tumor Necrosis Factor Receptor Superfamily Member 4 (ACT35 Antigen) Industry Research Report - Radiant Insights

Tumor Necrosis Factor Receptor Superfamily Member 4 (ACT35 Antigen or TAX Transcriptionally Activated Glycoprotein 1 Receptor or OX40L Receptor or CD134 or TNFRSF4) - Tumor Necrosis Factor Receptor Superfamily Member 4 or OX40 is a member of the TNF-receptor superfamily. This receptor has been shown to activate NF-kappaB through its interaction with adaptor proteins TRAF2 and TRAF5. OX40L binds to OX40 receptors on T-cells, preventing them from dying and subsequently increasing cytokine production. OX40 has a critical role in the maintenance of an immune response. OX40 also plays a crucial role in both Th1 and Th2 mediated reactions.

Tumor Necrosis Factor Receptor Superfamily Member 4 (ACT35 Antigen or TAX Transcriptionally Activated Glycoprotein 1 Receptor or OX40L Receptor or CD134 or TNFRSF4) pipeline Target constitutes close to 17 molecules. Out of which approximately 17 molecules are developed by Companies. The molecules developed by companies in Phase II, Phase I, Preclinical and Discovery stages are 5, 3, 5 and 4 respectively. Report covers products from therapy areas Oncology, Immunology, Dermatology, Gastrointestinal and Metabolic Disorders which include indications Solid Tumor, Head And Neck Cancer Squamous Cell Carcinoma, Non-Small Cell Lung Cancer, Bladder Cancer, Melanoma, Renal Cell Carcinoma, Atopic Dermatitis, Breast Cancer, Cervical Cancer, Colorectal Cancer, Endometrial Cancer, Gastric Cancer, Graft Versus Host Disease (GVHD), Hematological Tumor, Metastatic Cancer, Metastatic Hepatocellular Carcinoma (HCC), Metastatic Melanoma, Metastatic Ovarian Cancer, Metastatic Renal Cell Carcinoma, Soft Tissue Sarcoma, Systemic Lupus Erythematosus, Transplant Rejection, Type 1 Diabetes (Juvenile Diabetes) and Ulcerative Colitis.

Download Full Research Report @ https://www.radiantinsights.com/research/tumor-necrosis-factor-receptor-superfamily-member-4-act35-antigen

The latest report Tumor Necrosis Factor Receptor Superfamily Member 4 - Pipeline Review, H2 2017, outlays comprehensive information on the Tumor Necrosis Factor Receptor Superfamily Member 4 (ACT35 Antigen or TAX Transcriptionally Activated Glycoprotein 1 Receptor or OX40L Receptor or CD134 or TNFRSF4) targeted therapeutics, complete with analysis by indications, stage of development, mechanism of action (MoA), route of administration (RoA) and molecule type. It also reviews key players involved in Tumor Necrosis Factor Receptor Superfamily Member 4 (ACT35 Antigen or TAX Transcriptionally Activated Glycoprotein 1 Receptor or OX40L Receptor or CD134 or TNFRSF4) targeted therapeutics development with respective active and dormant or discontinued projects.

The report is built using data and information sourced from proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations and featured press releases from company/university sites and industry-specific third party sources.

Scope :

• The report provides a snapshot of the global therapeutic landscape for Tumor Necrosis Factor Receptor Superfamily Member 4 (ACT35 Antigen or TAX Transcriptionally Activated Glycoprotein 1 Receptor or OX40L Receptor or CD134 or TNFRSF4)

• The report reviews Tumor Necrosis Factor Receptor Superfamily Member 4 (ACT35 Antigen or TAX Transcriptionally Activated Glycoprotein 1 Receptor or OX40L Receptor or CD134 or TNFRSF4) targeted therapeutics under development by companies and universities/research institutes based on information derived from company and industry-specific sources

• The report covers pipeline products based on various stages of development ranging from pre-registration till discovery and undisclosed stages

• The report features descriptive drug profiles for the pipeline products which includes, product description, descriptive MoA, R&D brief, licensing and collaboration details & other developmental activities

• The report reviews key players involved in Tumor Necrosis Factor Receptor Superfamily Member 4 (ACT35 Antigen or TAX Transcriptionally Activated Glycoprotein 1 Receptor or OX40L Receptor or CD134 or TNFRSF4) targeted therapeutics and enlists all their major and minor projects

• The report assesses Tumor Necrosis Factor Receptor Superfamily Member 4 (ACT35 Antigen or TAX Transcriptionally Activated Glycoprotein 1 Receptor or OX40L Receptor or CD134 or TNFRSF4) targeted therapeutics based on mechanism of action (MoA), route of administration (RoA) and molecule type

• The report summarizes all the dormant and discontinued pipeline projects

• The report reviews latest news and deals related to Tumor Necrosis Factor Receptor Superfamily Member 4 (ACT35 Antigen or TAX Transcriptionally Activated Glycoprotein 1 Receptor or OX40L Receptor or CD134 or TNFRSF4) targeted therapeutics

Request a Free Sample Copy of this Report @ https://www.radiantinsights.com/research/tumor-necrosis-factor-receptor-superfamily-member-4-act35-antigen/request-sample

Reasons To Buy:

• Gain strategically significant competitor information, analysis, and insights to formulate effective R&D strategies

• Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage

• Identify and understand the targeted therapy areas and indications for Tumor Necrosis Factor Receptor Superfamily Member 4 (ACT35 Antigen or TAX Transcriptionally Activated Glycoprotein 1 Receptor or OX40L Receptor or CD134 or TNFRSF4)

• Identify the use of drugs for target identification and drug repurposing

• Identify potential new clients or partners in the target demographic

• Develop strategic initiatives by understanding the focus areas of leading companies

• Plan mergers and acquisitions effectively by identifying key players and it's most promising pipeline therapeutics

• Devise corrective measures for pipeline projects by understanding Tumor Necrosis Factor Receptor Superfamily Member 4 (ACT35 Antigen or TAX Transcriptionally Activated Glycoprotein 1 Receptor or OX40L Receptor or CD134 or TNFRSF4) development landscape

• Develop and design in-licensing and out-licensing strategies by identifying prospective partners with the most attractive projects to enhance and expand business potential and scope

See More Reports of This Category by Radiant Insights @ https://www.radiantinsights.com/catalog/pharmaceuticals-and-healthcare

About Radiant Insights Radiant Insights is a platform for companies looking to meet their market research and business intelligence requirements. It assist and facilitate organizations and individuals procure market research reports, helping them in the decision making process. The Organization has a comprehensive collection of reports, covering over 40 key industries and a host of micro markets. In addition to over extensive database of reports, experienced research coordinators also offer a host of ancillary services such as, research partnerships/ tie-ups and customized research solutions.

Media Contact: Company Name: Radiant Insights, Inc Contact Person: Michelle Thoras Email: sales@radiantinsights.com visit our website: http://www.radiantinsights.com/ Phone: (415) 349-0054 Toll Free: 1-888-928-9744 Address: 201 Spear Street 1100, Suite 3036, City: San Francisco State: California Country: United States

[hexamarketreports-blog]

Nasopharyngeal Cancer Market Therapeutics Drugs and Companies Pipeline Review, H2 2017

Summary

Pharmaceutical and Healthcare disease pipeline guide Nasopharyngeal Cancer - Pipeline Review, H2 2017, provides an overview of the Nasopharyngeal Cancer (Oncology) pipeline landscape.

Nasopharyngeal cancer is a rare type of head and neck cancer. It starts in the upper part of your throat, behind the nose. This area is called the nasopharynx. The risk factors of nasopharyngeal cancer may include Epstein-Barr virus. Symptoms of nasopharyngeal cancer may include blurry or double vision, difficulty speaking, including hoarseness, ear infections that keep coming back, face pain or numbness, headache, hearing loss, ringing in the ears. Treatment includes surgery, chemotherapy and radiation therapy.

Browse Detail Report With TOC @  https://www.hexareports.com/report/nasopharyngeal-cancer-pipeline-review-h2-2017

Report Highlights

Pharmaceutical and Healthcare latest pipeline guide Nasopharyngeal Cancer - Pipeline Review, H2 2017, provides comprehensive information on the therapeutics under development for Nasopharyngeal Cancer (Oncology), complete with analysis by stage of development, drug target, mechanism of action (MoA), route of administration (RoA) and molecule type. The guide covers the descriptive pharmacological action of the therapeutics, its complete research and development history and latest news and press releases.

The Nasopharyngeal Cancer (Oncology) pipeline guide also reviews of key players involved in therapeutic development for Nasopharyngeal Cancer and features dormant and discontinued projects. The guide covers therapeutics under Development by Companies /Universities /Institutes, the molecules developed by Companies in Phase III, Phase II, Phase I, Preclinical and Discovery stages are 2, 12, 13, 7 and 5 respectively. Similarly, the Universities portfolio in Phase II, Phase I and Preclinical stages comprises 8, 2 and 5 molecules, respectively.

Nasopharyngeal Cancer (Oncology) pipeline guide helps in identifying and tracking emerging players in the market and their portfolios, enhances decision making capabilities and helps to create effective counter strategies to gain competitive advantage. The guide is built using data and information sourced from Global proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations and featured press releases from company/university sites and industry-specific third party sources. Additionally, various dynamic tracking processes ensure that the most recent developments are captured on a real time basis.

Note: Certain content / sections in the pipeline guide may be removed or altered based on the availability and relevance of data.

Request A Sample copy of This Report @  https://www.hexareports.com/report/nasopharyngeal-cancer-pipeline-review-h2-2017/request-sample

Scope

The pipeline guide provides a snapshot of the global therapeutic landscape of Nasopharyngeal Cancer (Oncology).

The pipeline guide reviews pipeline therapeutics for Nasopharyngeal Cancer (Oncology) by companies and universities/research institutes based on information derived from company and industry-specific sources.

The pipeline guide covers pipeline products based on several stages of development ranging from pre-registration till discovery and undisclosed stages.

The pipeline guide features descriptive drug profiles for the pipeline products which comprise, product description, descriptive licensing and collaboration details, R&D brief, MoA & other developmental activities.

The pipeline guide reviews key companies involved in Nasopharyngeal Cancer (Oncology) therapeutics and enlists all their major and minor projects.

The pipeline guide evaluates Nasopharyngeal Cancer (Oncology) therapeutics based on mechanism of action (MoA), drug target, route of administration (RoA) and molecule type.

The pipeline guide encapsulates all the dormant and discontinued pipeline projects.

The pipeline guide reviews latest news related to pipeline therapeutics for Nasopharyngeal Cancer (Oncology)

Reasons To Buy

Procure strategically important competitor information, analysis, and insights to formulate effective R&D strategies.

Recognize emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage.

Find and recognize significant and varied types of therapeutics under development for Nasopharyngeal Cancer (Oncology).

Classify potential new clients or partners in the target demographic.

Develop tactical initiatives by understanding the focus areas of leading companies.

Plan mergers and acquisitions meritoriously by identifying key players and it's most promising pipeline therapeutics.

Formulate corrective measures for pipeline projects by understanding Nasopharyngeal Cancer (Oncology) pipeline depth and focus of Indication therapeutics.

Develop and design in-licensing and out-licensing strategies by identifying prospective partners with the most attractive projects to enhance and expand business potential and scope.

Adjust the therapeutic portfolio by recognizing discontinued projects and understand from the know-how what drove them from pipeline.

For More Details Visits @ Hexa Reports

[markresearch-blog]

Prostaglandin E2 Receptor EP4 Subtype - Pipeline Insight and Therapeutic Assessment, H2 2017

Albany, New York, August 18, 2017: Market Research Hub (MRH) has recently announced the addition of a fresh report, titled “Prostaglandin E2 Receptor EP4 Subtype (Prostanoid EP4 Receptor or PTGER4) - Pipeline Review, H2 2017” to its report offerings. The report reviews key players involved in Prostaglandin E2 Receptor EP4 Subtype (Prostanoid EP4 Receptor or PTGER4) targeted therapeutics development with respective active and dormant or discontinued projects.

Request Free Sample Report: http://www.marketresearchhub.com/enquiry.php?type=S&repid=1297804

According to the recently published report 'Prostaglandin E2 Receptor EP4 Subtype Pipeline Review, H2 2017'; Prostaglandin E2 Receptor EP4 Subtype (Prostanoid EP4 Receptor or PTGER4) pipeline Target constitutes close to 11 molecules. Out of which approximately 10 molecules are developed by companies and remaining by the universities/institutes. Prostaglandin E2 Receptor EP4 Subtype (Prostanoid EP4 Receptor or PTGER4) Prostaglandin E2 receptor 4 (EP4) is a prostaglandin receptor encoded by the PTGER4 gene. The activity of the receptor is mediated by G proteins that stimulate adenylate cyclase. It has a relaxing effect on smooth muscle. It plays an important role in regulating renal hemodynamics, intestinal epithelial transport, adrenal aldosterone secretion, and uterine function. The report 'Prostaglandin E2 Receptor EP4 Subtype Pipeline Review, H2 2017' outlays comprehensive information on the Prostaglandin E2 Receptor EP4 Subtype (Prostanoid EP4 Receptor or PTGER4) targeted therapeutics, complete with analysis by indications, stage of development, mechanism of action (MoA), route of administration (RoA) and molecule type; that are being developed by Companies / Universities. It also reviews key players involved in Prostaglandin E2 Receptor EP4 Subtype (Prostanoid EP4 Receptor or PTGER4) targeted therapeutics development with respective active and dormant or discontinued projects. Currently, The molecules developed by companies in Phase II, Phase I and Preclinical stages are 2, 3 and 5 respectively. Similarly, the universities portfolio in Discovery stages comprises 1 molecules, respectively. Report covers products from therapy areas Oncology, Immunology, Central Nervous System, Gastrointestinal, Dermatology, Metabolic Disorders, Respiratory and Women's Health which include indications Autoimmune Disorders, Breast Cancer, Allergies, Chronic Pain, Contact Dermatitis, Inflammatory Bowel Disease, Non-Small Cell Lung Cancer, Osteoarthritis Pain, Bladder Cancer, Cervical Cancer, Chronic Obstructive Pulmonary Disease (COPD), Colorectal Cancer, Endometriosis, Epithelial Ovarian Cancer, Gastrointestinal Tract Cancer, Head And Neck Cancer Squamous Cell Carcinoma, Hepatocellular Carcinoma, Inflammatory Pain, Lung Cancer, Osteoporosis, Pancreatic Cancer, Prostate Cancer, Rectal Cancer, Renal Cell Carcinoma, Rheumatoid Arthritis, Solid Tumor and Ulcerative Colitis. Scope - The report provides a snapshot of the global therapeutic landscape for Prostaglandin E2 Receptor EP4 Subtype (Prostanoid EP4 Receptor or PTGER4) - The report reviews Prostaglandin E2 Receptor EP4 Subtype (Prostanoid EP4 Receptor or PTGER4) targeted therapeutics under development by companies and universities/research institutes based on information derived from company and industry-specific sources - The report covers pipeline products based on various stages of development ranging from pre-registration till discovery and undisclosed stages - The report features descriptive drug profiles for the pipeline products which includes, product description, descriptive MoA, R&D brief, licensing and collaboration details & other developmental activities - The report reviews key players involved in Prostaglandin E2 Receptor EP4 Subtype (Prostanoid EP4 Receptor or PTGER4) targeted therapeutics and enlists all their major and minor projects - The report assesses Prostaglandin E2 Receptor EP4 Subtype (Prostanoid EP4 Receptor or PTGER4) targeted therapeutics based on mechanism of action (MoA), route of administration (RoA) and molecule type - The report summarizes all the dormant and discontinued pipeline projects - The report reviews latest news and deals related to Prostaglandin E2 Receptor EP4 Subtype (Prostanoid EP4 Receptor or PTGER4) targeted therapeutics Reasons to buy - Gain strategically significant competitor information, analysis, and insights to formulate effective R&D strategies - Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage - Identify and understand the targeted therapy areas and indications for Prostaglandin E2 Receptor EP4 Subtype (Prostanoid EP4 Receptor or PTGER4) - Identify the use of drugs for target identification and drug repurposing - Identify potential new clients or partners in the target demographic - Develop strategic initiatives by understanding the focus areas of leading companies - Plan mergers and acquisitions effectively by identifying key players and its most promising pipeline therapeutics - Devise corrective measures for pipeline projects by understanding Prostaglandin E2 Receptor EP4 Subtype (Prostanoid EP4 Receptor or PTGER4) development landscape - Develop and design in-licensing and out-licensing strategies by identifying prospective partners with the most attractive projects to enhance and expand business potential and scope

Read Full Report with TOC: http://www.marketresearchhub.com/report/prostaglandin-e2-receptor-ep4-subtype-prostanoid-ep4-receptor-or-ptger4-pipeline-review-h2-2017-report.html

Table of Contents:

Table of Contents 2 List of Tables 4 List of Figures 4 Introduction 5 Global Markets Direct Report Coverage 5 Prostaglandin E2 Receptor EP4 Subtype (Prostanoid EP4 Receptor or PTGER4) Overview 6 Prostaglandin E2 Receptor EP4 Subtype (Prostanoid EP4 Receptor or PTGER4) Therapeutics Development 7 Products under Development by Stage of Development 7 Products under Development by Therapy Area 8 Products under Development by Indication 9 Products under Development by Companies 12 Products under Development by Universities/Institutes 16 Prostaglandin E2 Receptor EP4 Subtype (Prostanoid EP4 Receptor or PTGER4) Therapeutics Assessment 18 Assessment by Mechanism of Action 18 Assessment by Route of Administration 20 Assessment by Molecule Type 22

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Market Research Hub (MRH) is a next-generation reseller of research reports and analysis. MRH’s expansive collection of market research reports has been carefully curated to help key personnel and decision makers across industry verticals to clearly visualize their operating environment and take strategic steps.

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[hallsara139]

Pharmaceutical and Healthcare latest pipeline guide Head And Neck Cancer - Pipeline Review, H2 2016, provides comprehensive information on the therapeutics under development for Head And Neck Cancer (Oncology), complete with analysis by stage of development, drug target, mechanism of action (MoA), route of administration (RoA) and molecule type. The guide covers the descriptive pharmacological action of the therapeutics, its complete research and development history and latest news and press releases.

[marketforecastreport-blog]

Analysis Report On Serine/Threonine Protein Kinase ATR (Ataxia Telangiectasia And Rad3 Related Protein) - Pipeline Review, H1 2017- Radiant Insights, Inc

According to the recently published report 'SerineThreonine Protein Kinase ATR Pipeline Review, H1 2017'; Serine/Threonine Protein Kinase ATR (Ataxia Telangiectasia And Rad3 Related Protein or FRAP Related Protein 1 or ATR or EC 2.7.11.1) pipeline Target constitutes close to 12 molecules. Out of which approximately 11 molecules are developed by companies and remaining by the universities/institutes. Serine/Threonine Protein Kinase ATR (Ataxia Telangiectasia And Rad3 Related Protein or FRAP Related Protein 1 or ATR or EC 2.7.11.1) Serine/threonine-protein kinase ATR is an enzyme encoded by the ATR gene. It is required for cell cycle arrest and DNA damage repair in response to DNA damage. It has shown to phosphorylate checkpoint kinase CHK1, checkpoint proteins RAD17, and RAD9, as well as tumor suppressor protein BRCA1. Browse Full Research Report With TOC:   http://www.radiantinsights.com/research/serine-threonine-protein-kinase-atr-ataxia-telangiectasia The report 'SerineThreonine Protein Kinase ATR Pipeline Review, H1 2017' outlays comprehensive information on the Serine/Threonine Protein Kinase ATR (Ataxia Telangiectasia And Rad3 Related Protein or FRAP Related Protein 1 or ATR or EC 2.7.11.1) targeted therapeutics, complete with analysis by indications, stage of development, mechanism of action (MoA), route of administration (RoA) and molecule type; that are being developed by Companies / Universities. It also reviews key players involved in Serine/Threonine Protein Kinase ATR (Ataxia Telangiectasia And Rad3 Related Protein or FRAP Related Protein 1 or ATR or EC 2.7.11.1) targeted therapeutics development with respective active and dormant or discontinued projects. Currently, The molecules developed by companies in Phase II, Phase I, Preclinical and Discovery stages are 2, 2, 5 and 2 respectively. Similarly, the universities portfolio in Discovery stages comprises 1 molecules, respectively. Report covers products from therapy areas Oncology which include indications Colorectal Cancer, Ovarian Cancer, Adenocarcinoma Of The Gastroesophageal Junction, Non-Small Cell Lung Cancer, Solid Tumor, Breast Cancer, Gastric Cancer, Glioblastoma Multiforme (GBM), Head And Neck Cancer Squamous Cell Carcinoma, Lung Adenocarcinoma, Mantle Cell Lymphoma, Metastatic Breast Cancer, Pancreatic Cancer, Prostate Cancer and Small-Cell Lung Cancer. Note: Certain content / sections in the pipeline guide may be removed or altered based on the availability and relevance of data. Scope:

The report provides a snapshot of the global therapeutic landscape for Serine/Threonine Protein Kinase ATR (Ataxia Telangiectasia And Rad3 Related Protein or FRAP Related Protein 1 or ATR or EC 2.7.11.1)

The report reviews Serine/Threonine Protein Kinase ATR (Ataxia Telangiectasia And Rad3 Related Protein or FRAP Related Protein 1 or ATR or EC 2.7.11.1) targeted therapeutics under development by companies and universities/research institutes based on information derived from company and industry-specific sources

The report covers pipeline products based on various stages of development ranging from pre-registration till discovery and undisclosed stages

The report features descriptive drug profiles for the pipeline products which includes, product description, descriptive MoA, R&D brief, licensing and collaboration details & other developmental activities

The report reviews key players involved in Serine/Threonine Protein Kinase ATR (Ataxia Telangiectasia And Rad3 Related Protein or FRAP Related Protein 1 or ATR or EC 2.7.11.1) targeted therapeutics and enlists all their major and minor projects

The report assesses Serine/Threonine Protein Kinase ATR (Ataxia Telangiectasia And Rad3 Related Protein or FRAP Related Protein 1 or ATR or EC 2.7.11.1) targeted therapeutics based on mechanism of action (MoA), route of administration (RoA) and molecule type

The report summarizes all the dormant and discontinued pipeline projects

The report reviews latest news and deals related to Serine/Threonine Protein Kinase ATR (Ataxia Telangiectasia And Rad3 Related Protein or FRAP Related Protein 1 or ATR or EC 2.7.11.1) targeted therapeutics

Reasons To Buy:

Gain strategically significant competitor information, analysis, and insights to formulate effective R&D strategies

Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage

Identify and understand the targeted therapy areas and indications for Serine/Threonine Protein Kinase ATR (Ataxia Telangiectasia And Rad3 Related Protein or FRAP Related Protein 1 or ATR or EC 2.7.11.1)

Identify the use of drugs for target identification and drug repurposing

Identify potential new clients or partners in the target demographic

Develop strategic initiatives by understanding the focus areas of leading companies

Plan mergers and acquisitions effectively by identifying key players and it's most promising pipeline therapeutics

Devise corrective measures for pipeline projects by understanding Serine/Threonine Protein Kinase ATR (Ataxia Telangiectasia And Rad3 Related Protein or FRAP Related Protein 1 or ATR or EC 2.7.11.1) development landscape

Develop and design in-licensing and out-licensing strategies by identifying prospective partners with the most attractive projects to enhance and expand business potential and scope

See More Reports of This Category by Radiant Insights: http://www.radiantinsights.com/catalog/pharmaceuticals-and-healthcare About Radiant Insights,Inc Radiant Insights is a platform for companies looking to meet their market research and business intelligence requirements. We assist and facilitate organizations and individuals procure market research reports, helping them in the decision making process. We have a comprehensive collection of reports, covering over 40 key industries and a host of micro markets. In addition to over extensive database of reports, our experienced research coordinators also offer a host of ancillary services such as, research partnerships/ tie-ups and customized research solutions. Contact Details: Michelle Thoras     Corporate Sales Specialist, USA Radiant Insights, Inc 28 2nd Street, Suite 3036, San Francisco, CA 94105, United States Phone: 1-415-349-0054 Toll Free: 1-888-202-9519 Email: sales@radiantinsights.com Web: http://www.radiantinsights.com/

[helloancycruzworld]

Transforming Growth Factor Beta 2 (BSC1 Cell Growth Inhibitor or Cetermin or Glioblastoma Derived T Cell Suppressor Factor or Polyergin or TGFB2) Pipeline H1 2017 Review Market Landscape and Top Companies Analyzed Report

Description:

According to the recently published report 'Transforming Growth Factor Beta 2 - Pipeline Review, H1 2017'; Transforming Growth Factor Beta 2 (BSC1 Cell Growth Inhibitor or Cetermin or Glioblastoma Derived T Cell Suppressor Factor or Polyergin or TGFB2) pipeline Target constitutes close to 7 molecules. Out of which approximately 6 molecules are developed by companies and remaining by the universities/institutes.

Request a sample of this report @ http://www.orbisresearch.com/contacts/request-sample/310029 .

Transforming Growth Factor Beta 2 (BSC1 Cell Growth Inhibitor or Cetermin or Glioblastoma Derived T Cell Suppressor Factor or Polyergin or TGFB2) - Transforming growth factor beta 2 (TGF-β2) is a polypeptide member of the transforming growth factor beta superfamily of cytokines encoded by the TGFB2 gene. It regulates proliferation, differentiation, adhesion and migration. It has suppressive effects on interleukin-2 dependent T-cell growth.

The report 'Transforming Growth Factor Beta 2 - Pipeline Review, H1 2017' outlays comprehensive information on the Transforming Growth Factor Beta 2 (BSC1 Cell Growth Inhibitor or Cetermin or Glioblastoma Derived T Cell Suppressor Factor or Polyergin or TGFB2) targeted therapeutics, complete with analysis by indications, stage of development, mechanism of action (MoA), route of administration (RoA) and molecule type; that are being developed by Companies / Universities.

Browse the full report @ http://www.orbisresearch.com/reports/index/transforming-growth-factor-beta-2-bsc1-cell-growth-inhibitor-or-cetermin-or-glioblastoma-derived-t-cell-suppressor-factor-or-polyergin-or-tgfb2-pipeline-review-h1-2017 .

It also reviews key players involved in Transforming Growth Factor Beta 2 (BSC1 Cell Growth Inhibitor or Cetermin or Glioblastoma Derived T Cell Suppressor Factor or Polyergin or TGFB2) targeted therapeutics development with respective active and dormant or discontinued projects. Currently, The molecules developed by companies in Phase II, Phase I and Preclinical stages are 2, 1 and 3 respectively. Similarly, the universities portfolio in Preclinical stages comprises 1 molecule, respectively. Report covers products from therapy areas Oncology, Ophthalmology, Dermatology, Gastrointestinal, Genetic Disorders, Genito Urinary System And Sex Hormones, Musculoskeletal Disorders and Respiratory which include indications Glioblastoma Multiforme (GBM), Open-Angle Glaucoma, Choroidal Neovascularization, Fibrosis, Head And Neck Cancer, Idiopathic Pulmonary Fibrosis, Kidney Fibrosis, Liver Fibrosis, Melanoma, Metastatic Breast Cancer, Metastatic Lung Cancer, Non-Small Cell Lung Cancer, Osteogenesis Imperfecta, Pancreatic Cancer, Proliferative Vitreoretinopathy (PVR) and Scar.

Scope - The report provides a snapshot of the global therapeutic landscape for Transforming Growth Factor Beta 2 (BSC1 Cell Growth Inhibitor or Cetermin or Glioblastoma Derived T Cell Suppressor Factor or Polyergin or TGFB2) - The report reviews Transforming Growth Factor Beta 2 (BSC1 Cell Growth Inhibitor or Cetermin or Glioblastoma Derived T Cell Suppressor Factor or Polyergin or TGFB2)targeted therapeutics under development by companies and universities/research institutes based on information derived from company and industry-specific sources  - The report covers pipeline products based on various stages of development ranging from pre-registration till discovery and undisclosed stages  - The report features descriptive drug profiles for the pipeline products which includes, product description, descriptive MoA, R&D brief, licensing and collaboration details & other developmental activities  - The report reviews key players involved in Transforming Growth Factor Beta 2 (BSC1 Cell Growth Inhibitor or Cetermin or Glioblastoma Derived T Cell Suppressor Factor or Polyergin or TGFB2)targeted therapeutics and enlists all their major and minor projects  - The report assesses Transforming Growth Factor Beta 2 (BSC1 Cell Growth Inhibitor or Cetermin or Glioblastoma Derived T Cell Suppressor Factor or Polyergin or TGFB2) targeted therapeutics based on mechanism of action (MoA), route of administration (RoA) and molecule type  - The report summarizes all the dormant and discontinued pipeline projects  - The report reviews latest news and deals related to Transforming Growth Factor Beta 2 (BSC1 Cell Growth Inhibitor or Cetermin or Glioblastoma Derived T Cell Suppressor Factor or Polyergin or TGFB2) targeted therapeutics

Purchase a copy of this report @ http://www.orbisresearch.com/contact/purchase/310029 .

Reasons to buy - Gain strategically significant competitor information, analysis, and insights to formulate effective R&D strategies - Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage  - Identify and understand the targeted therapy areas and indications for Transforming Growth Factor Beta 2 (BSC1 Cell Growth Inhibitor or Cetermin or Glioblastoma Derived T Cell Suppressor Factor or Polyergin or TGFB2) - Identify the use of drugs for target identification and drug repurposing - Identify potential new clients or partners in the target demographic - Develop strategic initiatives by understanding the focus areas of leading companies  - Plan mergers and acquisitions effectively by identifying key players and it’s most promising pipeline therapeutics - Devise corrective measures for pipeline projects by understanding Transforming Growth Factor Beta 2 (BSC1 Cell Growth Inhibitor or Cetermin or Glioblastoma Derived T Cell Suppressor Factor or Polyergin or TGFB2)development landscape  - Develop and design in-licensing and out-licensing strategies by identifying prospective partners with the most attractive projects to enhance and expand business potential and scope

Companies Mentioned Autotelic Inc Genzyme Corp Isarna Therapeutics GmbH Novartis AG

Purchase a copy of this report @ http://www.orbisresearch.com/contact/purchase/310029 .

For any enquires before buying, connect with us @ enquiry@orbisresearch.com

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Hypopharyngeal Cancer Therapeutics Drugs and Companies Pipeline Review, H1 2017

Hypopharyngeal Cancer - Pipeline Review, H1 2017, provides in depth analysis on Hypopharyngeal Cancer targeted pipeline therapeutics. The report provides comprehensive information on the Hypopharyngeal Cancer targeted therapeutics, complete with analysis by indications, stage of development, mechanism of action (MoA), route of administration (RoA) and molecule type.

The report also covers the descriptive pharmacological action of the therapeutics, its complete research and development history and latest news and press releases. Additionally, the report provides an overview of key players involved in Hypopharyngeal Cancer targeted therapeutics development and features dormant and discontinued projects.

Browse Detail Market Report With TOC @ http://www.hexareports.com/report/hypopharyngeal-cancer-pipeline-review-h1-2017

Hypopharyngeal cancer is a term used for tumors of a subsite of the upper aerodigestive tract, and like most other subsite designations, the distinction is anatomic rather than pathophysiologic within the group of head and neck malignancies. The hypopharynx is the region between the oropharynx above (at the level of the hyoid bone) and the esophageal inlet below (at the lower end of the cricoid cartilage). Embryologically, the larynx interjects into the hypopharynx anteriorly and is therefore considered a separate structure.

The report helps in identifying and tracking emerging players in the market and their portfolios, enhances decision making capabilities and helps to create effective counter strategies to gain competitive advantage.

Scope of this Report:

The report provides a snapshot of the global therapeutic landscape for Hypopharyngeal Cancer

The report reviews Hypopharyngeal Cancer targeted therapeutics under development by companies and universities/research institutes based on information derived from company and industry-specific sources

The report covers pipeline products based on various stages of development ranging from pre-registration till discovery and undisclosed stages

The report features descriptive drug profiles for the pipeline products which includes, product description, descriptive MoA, R&D brief, licensing and collaboration details & other developmental activities

The report reviews key players involved in Hypopharyngeal Cancer targeted therapeutics and enlists all their major and minor projects

The report assesses Hypopharyngeal Cancer targeted therapeutics based on mechanism of action (MoA), route of administration (RoA) and molecule type

The report summarizes all the dormant and discontinued pipeline projects

The report reviews latest news and deals related to Hypopharyngeal Cancer targeted therapeutics

Request A Sample copy of This Report @ http://www.hexareports.com/report/hypopharyngeal-cancer-pipeline-review-h1-2017/request-sample

Reasons To Buy

Gain strategically significant competitor information, analysis, and insights to formulate effective R&D strategies

Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage

Classify potential new clients or partners in the target demographic.

Develop tactical initiatives by understanding the focus areas of leading companies.

Plan mergers and acquisitions meritoriously by identifying key players and it's most promising pipeline therapeutics.

Formulate corrective measures for pipeline projects by understanding Hypopharyngeal Cancer pipeline depth and focus of Indication therapeutics.

Develop and design in-licensing and out-licensing strategies by identifying prospective partners with the most attractive projects to enhance and expand business potential and scope.

Adjust the therapeutic portfolio by recognizing discontinued projects and understand from the know-how what drove them from pipeline.

About Us:

Hexa Reports is a market research and consulting organization, offering industry reports, custom research and consulting services to a host of key industries across the globe. We offer comprehensive business intelligence in the form of industry reports which help our clients obtain clarity about their business environment and enable them to undertake strategic growth initiatives.

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