#cost of Avastin Injection

[avastininjection]

Cancer is a treatable disease if detected in early stages. Early detection is not possible as it does not show any symptoms. Healthcare experts prescribe Avastin Injection to the person diagnosed with cancer. This medicine should be administered by an experienced nurse or doctor.

[radhika677]

Lenalidomide capsule  price in India

Lidmed contains Lenalidomide as an active ingredient and this medicine is available in the strength of 10mg and 25mg. This anti-cancer medication is prescribed for the treatment of Multiple Myeloma and Lepra Reaction. Lenalidomide capsule works by blocking the growth and spread of cancer cells in the body. 

[advancedretinacare]

Best Eye Hospitals in Hyderabad

Advanced Retina Care is one of the best eye hospitals in Hyderabad. Our eye hospital offers the latest eye surgery and most advanced retina treatment.

With the best technology and a top retina surgeon, this eye hospital has become one of the best eye hospitals in Hyderabad. Our highly experienced eye surgeon, Dr. Anina Abraham, has performed thousands of successful retina surgeries. Patients have been extremely satisfied with the eye treatment and advanced eye care provided.

Advanced Retina Care has the best eye surgery available for cataract. The latest technology at minimal cost is available for patients who need to undergo cataract surgery. Our cataract surgeon has had the highest experience with the most complicated cataracts, giving patients excellent vision within minutes of the cataract surgery. Cataract surgery is performed within minutes without even a local anesthesia, giving the patient excellent vision within moments. In spite of offering the best eye care, cataract surgery cost is minimum at our eye hospital. This makes Advanced Retina Care the best eye hospital.Laser eye surgery at Advanced Retina Care has a very high success rate.

Patients have to wait for a very short time to be examined and treated, unlike any other eye hospital. Personal attention is given to every patient. Thousands of patients have expressed gratitude and rated our hospital as the best eye hospital in Hyderabad. In spite of being one of the best eye hospitals in Hyderabad and having the best retina specialist in Hyderabad, this hospital has very basic and minimal charges for all procedures.

Advanced Retina Care has kept up to the standards of being the best eye hospital in Hyderabad. It is clean and well sanitized. It has a beautiful infrastructure and is one of the most well maintained and best eye hospitals in Hyderabad.

Advanced Retina Care has one of the best retina surgeons in Hyderabad. Dr. Abraham, hails from L V Prasad Eye Institute (LVPEI), Hyderabad, one of the best eye hospitals in Hyderabad. Dr. Anina Abraham has gained excellent clinical acumen and surgical skills over the years.

Retinal detachment surgery and vitrectomy have been performed for thousands of patients with excellent results. Retinal laser treatment has prevented blindness for patients with retinal tear, floaters, and diabetic retinopathy. Patients with diabetic retinopathy which led to blindness have been cured at our eye hospital. Operations are performed with the best equipment, requiring no stitches. Patients are comfortable within a day of surgery. Very quick recovery has been experienced by patients and they have said that Advanced Retina Care is the best eye hospital in Hyderabad.

Patients with advanced diabetic retinopathy have been treated with injections like avastin, accentrix and ozurdex with excellent results. We offer almost painless injections with fine gauge needles to minimize patient discomfort. Advanced Retina Care is one of the best eye hospitals caring for every patient.

Macular degeneration and macular edema have been treated here with excellent results. Dr. Abraham's methods and injection combos have helped prevent recurrence of disease. Requirement for repeated eye injections has reduced dramatically for hundreds of patients, proving the non-commercial nature of our services. For More Information : https://advancedretinacare.com/

[healthcare-market]

Monoclonal Antibodies Market Estimated to Expand at a Robust CAGR by 2024

Global Monoclonal Antibodies Market: Overview

Antibodies, which are proteins generated by plasma cells in response to specific antigens, is used for diagnostic and therapeutic purposes. Monoclonal antibodies (mAbs), a type of mono-specific antibodies, are comprised of identical antibody molecules and are produced by a single clone of cells or cell line. Monoclonal antibodies have brought about a fundamental change in pharmaceutical and biotechnology sectors and in the future too are slated to play a crucial role in clinical protocol with further development of these molecular agents. Monoclonal antibodies find application in the treatment of a variety of diseases, particularly autoimmune, cancer, and inflammatory diseases.

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The global monoclonal antibodies market is characterized by the presence of numerous global and regional players and is dynamic in nature. The well-entrenched players compete with the local ones on the basis of technology, cost, and product differentiation. Buying into the promise of robust growth in the future, more players will likely try and foray into the market. However, strict guidelines surrounding the manufacture of mAbs may act as a deterrent.

The report provides a detailed analysis of the opportunities and trends in the global monoclonal antibodies market. It segments the global market based on different parameters in order to study them in depth with expert inputs from industry veterans. The report provides a detailed assessment of the prevailing vendor landscape. It also profiles the leading players operating in the market and leveraging industry-leading analytical tools, gauges the threats and opportunities that these companies may face over the course of the forecast period between 2016 and 2024.

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Global Monoclonal Antibodies Market: Trends and Opportunities

Driving the growth of the global monoclonal antibodies market is the increasing prevalence of cancer and other chronic diseases. Such maladies have resulted in soaring demand for biologics, which in turn is leading to the demand for monoclonal antibodies. Rising thrust on research and development activities in genomics alongside the emergence of technologically advanced genetic platforms, such as next generation sequencing, have also majorly contributed to the market. In addition, the affordability of the technology needed for research to develop mAbs has also contributed to the growth in the market.

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Other factors positively impacting the market are rising awareness among patients and physicians regarding applications of mAb therapy, unveiling of better products every now and then, growing adoption of therapeutic antibodies in cost-sensitive markets, and quick approval by regulatory authorities for breakthrough therapies. Going forward, swift approvals of blockbuster mAbs for different indications, is further slated to up their usage. For example, popular drugs such as Herceptin, Avastin, Rituxan, and Remicade on the back of FDA approval for treating Crohn's disease, cancer, rheumatoid arthritis, ulcerative colitis, etc. would further boost the market.

One drawback of drugs formulated from mAbs is that they are very specific in nature and have limited targets. This is because they just interact with cells and do not penetrate them. This to some extent has hampered the global monoclonal antibodies market. Another difficulty in using mAbs is that they need to be injected unlike small molecule drugs.

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Global Monoclonal Antibodies Market: Regional Outlook

Geographically, the global market for monoclonal antibodies can be segmented into Europe, North America, Asia Pacific, and the Rest of the World. Among them, North America holds a dominant position in the market on account of the presence of well-established healthcare infrastructure, increased emphasis by the government for infection control and management, and increasing prevalence of lifestyle-related diseases. In the near future, the market will continue on its upward trajectory due increased funding by the government for cancer research and technology development.

Going forward, Asia Pacific is also predicted exhibit considerable growth owing to rising spending power of the people in the region along with increasing spend on research and development and growing patient awareness pertaining to the therapeutic use of mAbs. By dint of being underpenetrated too, the Asia Pacific market holds out a promise of robust growth.

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Companies Mentioned in Report

To present an in-depth assessment of the competition prevailing in the market, the report profiles companies such as Roche, Eli Lilly, Genentech, Pfizer, and Biogen Idec. The report not just profiles such leading players, but also brings to the fore their strengths and weaknesses.

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[pharmaphorumuk]

UK patient group warns COVID could limit access to Novartis’ new eye drug

NICE has recommended regular NHS funding for Novartis’ long-acting eye drug Beovu (brolucizumab) in England and Wales – but a patient group warned that access could be limited until the pandemic recedes because of disruption to ophthalmology clinics.

In final guidance NICE said trials have shown Novartis’ Beovu has similar efficacy in wet advanced macular degeneration (AMD) to rival Eylea (aflibercept) from Bayer/Regeneron and Novartis predecessor Lucentis (ranibizumab).

But after an initial loading phase it cuts the number of hospital visits required to get the same clinical effect, with a dosing period of up to 12 weeks.

More than half of patients were maintained on 12-weekly dosing regimens after the loading phase in a 48-week trial, Novartis pointed out.

Eylea requires injections every eight weeks following a loading period, while the dosing period for Lucentis is at least four weeks.

Roche’s cancer drug Avastin (bevacizumab) can also be used off-label to treat wet AMD, but as it has never been formally approved by regulators, NICE did not consider it in its cost-effectiveness analysis.

Cathy Yelf, CEO of the Macular Society, welcomed the news from NICE, which rushed Beovu through its process  following European approval around a year ago.

Yelf said that the first generation of drugs for wet AMD “changed the landscape” for patients.

But the regular injections can be a strain and can cause patients considerable anxiety as they don’t want to lose their sight by missing an appointment.

This can impact on decisions such as whether to take a holiday, she said.

“It is very burdensome for healthcare systems and patients to have repeated engagements. Anything that extends the time between injections is an enormous boost for the NHS and health systems.”

Yelf said the COVID-19 pandemic will limit access, as ophthalmology has been severely hit by the ongoing disruption to services.

“When the coronavirus crisis is over we hope we will see the effects of this drug. COVID has had a terrible effect on other bits of the NHS and ophthalmology has been badly affected. It’s caused a big backlog of treatment.”

Roche is developing faricimab, a rival to Beovu that could extend the time between injections to as long as 16 weeks, and Yelf is looking forward to other approaches that could benefit patients.

The Swiss pharma is trying to develop an implant that slowly releases the drug over a period of several months, she noted.

Delivering drugs for wet AMD using eye drops is another possibility, but this is made difficult because the eye is designed to prevent foreign material from reaching the retina.

She added: “Ideally we want to look at interventions to prevent the sight loss from starting to happen, we would like to intervene at a much earlier stage.”

The post UK patient group warns COVID could limit access to Novartis’ new eye drug appeared first on .

from https://pharmaphorum.com/news/patient-group-warns-covid-limit-access-novartis-eye-drug/

[kunalcmi]

CANCER BIOLOGICS MARKET ANALYSIS(2020-2027)

Biologic drug is a product that contain components of living organisms such as animal, human, or produced from living organisms. Antibodies, vaccines, and interleukins are some examples of biologic drugs. Furthermore, biologic drugs are administrated by injection or infusion, as biologic products can easily lose their potency due to acid present in the stomach, if administered by oral route to the patient. Moreover, biologic drug for cancer treatment helps to increase the body’s ability to fight against various types of cancers such as nasopharyngeal cancer, prostate cancer, breast cancer, neck cancer, and lung cancer. Pembrolizumab, Atezolizumab, Cemiplimab-rwlc, Blinatumomab and Durvalumab are few examples of biologic drugs that are used for the treatment of cancer.

 Global Cancer Biologics Market Drivers

The global cancer biologics market is expected to witness significant growth over the forecast period, owing to increasing approvals of biologic drug by regulatory authorities for the treatment of cancer. For instance, in 2018, the U.S Food and Drug Administration (FDA) approved blinatumomab, for the patient suffering from B-cell precursor acute lymphoblastic leukemia, which show reduction in the severity of the disease, as the minimal residual disease (MRD) is found to be greater than or equal to 0.1%. Furthermore, in 2018, U.S FDA approved Cemiplimab-rwlc, for the treatment metastatic advanced stage cutaneous squamous cell cancer. The recommended Cemiplimab-rwlc dose for the patient is 350 mg, which is administrated as intravenous infusion over 30 minutes, in every three weeks.

Moreover, in January 2020, F. Hoffmann-La Roche AG announced about its submission of supplemental biological license to U.S Food and Drug Administration (FDA) for Tecentriq (atezolizumab), in combination with Avastin (bevacizumab) drug for most common form of liver cancer. Therefore, increasing number of regulatory approvals of biologic drug for the treatment of cancer, is expected to boost of cancer biologics market growth over the forecast period.

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 Global Cancer Biologics Market Restraints

However, high cost associated with cancer biologic drug is one of the major restraint that is expected to hamper the global cancer biologics market growth. For instance, cost of blinatumomab is US$ 17,800 per year. Furthermore, side effects associated with cancer biologic drug such as allergic reactions, injection site reactions, weakness, diarrhea, nausea, vomiting, and rash yet remains another factor hindering the global cancer biologics market growth.

 Global Cancer Biologics Market Regional Analysis

North America is expected to account for highest market share in the global cancer biologics market, owing to increasing prevalence of cancer, among people in North America. For instance, in 2019, in the U.S, according to the American Cancer Society’s (ACS), around 1,762,450 new cancer cases were diagnosed, and 606,880 new cancer deaths were reported.

Furthermore, increasing drug approvals for the treatment of metastatic merkel cell carcinoma (MCC) by the company is one of the factors that is driving the global cancer biologic market growth. For instance, in 2018, pembrolizumab received approval from the U.S. Food and Drug Administration (FDA) for the treatment of patients suffering from metastatic Merkel cell carcinoma (MCC).

Europe is expected to account for second highest market share in the global cancer biologics market, owing to increasing prevalence of cancer in Europe region. For instance, in 2018, around 3.9 million of cancer with new cases excluding non-melanoma skin cancer, and 1.9 million death from cancer were reported by the International Agency for Research on Cancer (IARC), in collaboration with the European Network of Cancer Registries (ENCR, as well as the European Commission’s Joint Research Centre (JRC).

Moreover, Asia Pacific is expected to exhibit CAGR over the forecast period due to the increasing approval of drugs by regulatory bodies for the treatment of Hodgkin's disease (blood cancer) by the company. For instance, in 2018, National Medical Products Administration (NMPA) of China approved Sintilimab injection, which is sold under the brand name Tyvyt, and was jointly announced by Innovent Biologics, Inc. and Eli Lilly and Company. Sintilimab injection is used for the treatment of Hodgkin's disease (blood cancer), and is fully human IgG4 monoclonal antibody.

 Global Cancer Biologics Market Key Players

Key players operating in the global cancer biologic market are Merck & Co., Inc., Novartis International AG, F. Hoffmann-La Roche AG, Eli Lilly and Company, Bristol-Myers Squibb Company, Amgen Inc., Pfizer Inc., Sanofi S.A., Bayer AG, EnGeneIC Ltd, and GlaxoSmithKline PLC.

 Market Taxonomy:

 On the basis of product, the global cancer biologics market is segmented into:

Monoclonal Antibodies

Naked Monoclonal Antibodies

Conjugated Monoclonal Antibodies

Chemo labeled Antibodies

Radiolabeled Antibodies

Bispecific Monoclonal Antibodies

Cytokine-Based Immunotherapy

Cancer Vaccines

Treatment Vaccines

Preventive Vaccines

CAR-T Cell Therapy

Immune Checkpoint Inhibitors

CTL-4 Checkpoint Inhibitor

PD-1 & PD-L1 Checkpoint Inhibitor

On the basis of application, the global cancer biologics market is segmented into:

Non-Small Cell Lung Cancer

Prostate Cancer

Breast Cancer

Acute Myeloid Leukemia

Lymphoma

Multiple Myeloma

Ovarian Cancer

Colorectal Cancer

Gastric Cancers

Others

On the basis of distribution channel, the global cancer biologics market is segmented into:

Hospital

Clinics

Others

On the basis of region, the global cancer biologics market is segmented into:

North America

Latin America

Europe

Middle East

Asia Pacific

Africa

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Source: https://www.coherentmarketinsights.com/ongoing-insight/cancer-biologics-market-4145

[kyprelaw]

Justice Department Accuses Regeneron Of Paying Kickbacks Via Charity To Boost Expensive Drug

By Eman Amawi, University of Kentucky, Class of 2021

July 14, 2020

Regeneron Pharmaceuticals of Tarrytown, NY, is being sued by the US Attorney’s Office for health care fraud. In 2011, the biotechnology company, known for inventing medicines for serious illnesses, created a drug called Eylea. As their top selling drug, it brought in more than $4.6 billion in revenue in 2019 alone. Eylea treats wet macular degeneration, a common eye disease in older individuals and runs at a cost of $1,850 per dose.In total, it costs more than $10,000 a year, and copays for Medicare patients can top $2,000 a year.[1]

According to the US Department of Justice, following the creation of Eylea, Regeneron began providing funds to a charity foundation called the Chronic Disease Fund, which used the money to aid individuals with Medicare health insurance in paying their co-pays for Eylea prescriptions.[2] The large majority of patients who applied for financial assistance through the charity, whose name has since been changed to Good Days, had their copays entirely covered. Before Regeneron funneled tens of millions of dollars to the foundation, it confirmed the money would only go towards its drugs, and not those of competitors. Among Eylea’s competitors are Lucentis at $2,000 a dose and a much cheaper drug called Avastin at $55 a dose. Although all three drugs have been found to have similar efficiencies, the charity only provided help to those prescribed to Lucentis or Eylea, causing Avastin to become more expensive for patients. For this reason, doctors commonly prescribed Lucentis and Eylea, “so as not to impose large Medicare co-pays on their patients or risk being unable to collect those co-pays,” the lawsuit said.[1]

United States Attorney Andrew E. Lelling stated, “Regeneron allegedly paid these substantial sums only after confirming that the foundation needed the money to cover co-pays only for Eylea, and not for competing drugs, and that the company’s payments would generate a handsome return on investment, or ‘ROI,’ in the form of Medicare payments for Eylea. Furthermore, senior company executives allegedly took extensive measures to cover up the scheme.”[3]

Regeneron allegedly hired Xcenda, a division of Amerisource Bergen, to quantify how donations to the foundation would return Medicare dollars to Regeneron.Xcenda, a consulting company for pharmaceutical and biotech manufacturers, advised Regeneron to increase the price of Eylea from its original cost of $1,500 to $1,950 per injection to increase its return. Xcenda informed that although the payments to the charity foundation would have to increase, the revenue increase would offset this amount. Regeneron ultimately decided to price the drug at $1,850 and its financial staff later concluded the 2013 donations would result in nearly $200 million in additional sales, considering this a 465% return on investment.[4]According to the lawsuit, executives at Regeneron also were in constant contact with the charity, in an attempt to keep close track of exactly how much money was needed to go towards payments of Eylea, and would only donate that amount.Following the copayments, Medicare in return has spent over $11.5 billion on the drug since 2013.[5]

The Justice Department’s complaint alleges that the $75 million Regeneron paid the charity to cover patient co-payments from 2013 to 2014 were illegal kickbacks that violated the Federal False Claims Act.Ordinarily, it is legal for a large pharmaceutical manufacturer to make legitimate donations to a patient assistance foundation. However, it becomes illegal when donations are made to increase sales of the drug. 

The Anti-Kickback Statute prohibits medical providers from “offering, soliciting, paying, or receiving anything of value in exchange for referrals of patients whose resulting treatment will be paid for by a federal health care program (e.g., Medicare, Medicaid, TRICARE, and others).” Discounts are a form of kickback under the Anti-Kickback Statute. Therefore, when a provider regularly waives copays in order to make its services seem cheaper, it is offering a thing of value and violates the Statute. In addition, providers and manufacturers often use these copay waivers to encourage doctors to prescribe their drugs instead of cheaper generic competitors. The Anti-Kickback Statute also prohibits offering discounts to induce prescriptions or referrals of your product.[4]Regeneron took advantage of the fact that doctors were prescribing its drug over competitors and hiked its price of Eylea to increase their revenue.[5]

The False Claims Act states that “any person who: (A) knowingly presents, or causes to be presented, a false or fraudulent claim for payment or approval; or (B) knowingly makes, uses, or causes to be made or used, a false record or statement material to a false or fraudulent claim; . . . is liable to the United States Government for a civil penalty of not less than $5,000 and not more than $10,000, as adjusted by the Federal Civil Penalties Inflation Adjustment Act of 1990, plus 3 times the amount of damages which the Government sustains because of the act of that person.”[3]

Regeneron’s fraudulent claim allowed it to receive billions of dollars from the government through the Medicare program, therefore violating the FCA. The act defines the word “claim” as a request or demand for money that is made to a contractor, grantee or recipient and is used on the government’s behalf or to advance a government program- and also if the US government has provided any portion of the money requested or will be reimbursing the contractor, grantee or recipient for any portion of the money requested. [3]In addition, the FCA does not require proof that the fraudster had prior intent to defraud the Government. Rather, if a person had actual knowledge that a statement or claim was false, acted in deliberate ignorance of whether information was true or false, or acted in reckless disregard of truth or falsity, they are in violation of the act.[4]

Prosecutors allege that Regeneron’s senior management knew the conduct was illegal. In 2013, the company’s auditors inquired about the information Regeneron was receiving from the charity about Eylea. Regeneron management, including the company’s commercial chief, lied and stated that the company was not receiving specific data about Eylea from the foundation. The executives were aware that the company was in fact getting reports and spreadsheets from the foundation and using them to determine the spending on copays for Eylea.[3]

Regeneron has since issued a statement saying that its donations were lawful and that it would vigorously defend itself, following its complaint that the lawsuit will hinder Regeneron’s efforts to fight COVID-19, as the company has been working on providing an effective treatment for the virus. In addition, Good Days settled another anti-kickback case in 2019 concerning copays for other pharmaceutical companies. The charity agreed to pay a $2 million dollar penalty without admitting wrongdoing under the anti-kickback law. [5]

Dozens of drug makers have been investigated by the Justice Department over donations to copay-assistance foundations, as this scheme is a growing focus of government prosecutors. Several other companies including Johnson & Johnson and Pfizer Inc. have reached settlements in recent years to resolve Justice Department investigations of their contributions to the copay foundations.[2]

“Kickback schemes can undermine our healthcare system, compromise medical decisions, and waste taxpayer dollars,” said Phillip Coyne, Special Agent in Charge, Office of the Inspector General of the Department of Health and Human Service’s Boston Regional Office. “We will continue to hold pharmaceutical companies accountable for subverting the charitable donation process in order to circumvent safeguards designed to protect the integrity of the Medicare program.”[3]

________________________________________________________________

Eman Amawi is a rising senior at the University of Kentucky, pursuing a degree in Business Management with a minor in Communication. Her interests include business law, civil rights law, and immigration law. She plans to obtain a JD after graduation.

________________________________________________________________

[1]https://www.nytimes.com/2020/06/24/health/drug-kickbacks-regeneron.html

[2]https://www.wsj.com/articles/justice-department-sues-regeneron-over-payments-to-copay-assistance-charity-11593024042?mod=searchresults&page=1&pos=4

[3]https://www.justice.gov/usao-ma/pr/united-states-files-suit-against-drug-manufacturer-regeneron-paying-kickbacks-through-co

[4]https://www.whistleblowerllc.com/doj-sues-regeneron-for-copay-fraud/#:~:text=The%20Massachusetts%20U.S.%20Attorney's%20Office,prescriptions%20for%20its%20drug%20Eylea.

[5]https://www.barrons.com/articles/regeneron-used-a-charity-to-pay-kickbacks-justice-department-alleges-51593178899

[enal-agzakhana]

Avastin Injection Uses, Dosage, Side Effects, Precautions

Avastin Injection Uses, Dosage, Side Effects, Precautions

Important to know about Avastin Injection ?

Bevacizumab is a monoclonal antibody. This is a targeted anti-cancer agent ( ‘targeted therapy’). It reduces proliferation of blood vessels.

Avastin Injection Uses, Dosage, Side Effects, Precautions

Physicians write it for at cancerof the colon, the rectum (the last part of the rectum), the breasts, lungs, kidney, cervix, ovaries, and fallopian tubes…

[decisionforsight]

Global Biologics Market

Global Biologics Market Size, Share, Growth, Industry Trends and Forecast 2020-2030

Biologics are pharmaceutical products derived from living cells or micro-organisms. These are complex and large molecules comprising of proteins, peptides, nucleic acids, sugars, cellular structures or a combination of all the above. The biologics drug discovery process involves target identification, hit-to-lead stage, lead identification & optimization. Technologies applied for the development of biologics include genomics, proteomics, microarrays, cell cultures, phage display technologies and monoclonal antibody technologies. Biologics include genes that control production of vital proteins; proteins that control the action of other proteins and cellular processes; and modify human hormones or cells that produce products that suppress or activate the components of the immune system. They are used for the treatment of various diseases such as rheumatoid arthritis, ulcerative colitis, and other autoimmune diseases. The common side effects of biologics drugs observed are weakness, chills, allergic reactions, nausea, diarrhoea, itching, vomiting, injection side reaction, constipation, cough, headache, fever, shortness of breath, fever, dizziness, and others. The major biologics drugs presently available in the market are Humira, Remicade, Enbrel, Avastin and Herceptin. The global biologics market is projected to reach USD 559.6 billion by 2030 from USD 274.1 billion in 2020, at an approximate CAGR of 7.40%.

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Market Dynamics and Factors:

Rising prevalence of chronic diseases, incessant research and development activities, and continuous investment in biologics are the major factors attributing to the market growth of the biologics market across the globe. For instance, according to the World Health Organization (WHO), by 2020 chronic diseases would constitute around 75% of the total deaths worldwide.  Cancer, autoimmune diseases, and diabetes attribute to almost 60% of the overall biologics market. In 2016, approximately 50% of the new molecular units approved by the Food and Drug Administration were biologics. Continuous advancements in cellular & gene therapy further catalyses the market because of its high efficacy and therapeutic outcome. Furthermore, other major factors such as rising expenditure on healthcare, increased availability of advanced diagnostics, and growing applications of monoclonal antibodies for the treatment of different diseases are also positively impacting the overall growth of the global biologics market. However, certain factors like the emergence of biosimilars, high cost of biologics, lack of oral absorption and operational challenges are restraining the market growth of the global biologics market

Market Segmentation :

Global Biologics Market – By Source

Microbial

Mammalian

Others

Global Biologics Market – By Product Type

Monoclonal Antibody

Interleukins

Vaccines

Growth Factors

Gene Therapy

Others

Global Biologics Market – By Disease Indication

Immunological Disorders

Cardiovascular Disorders

Hematological Disorders

Cancer

Arthritis

Diabetes

Others

Global Biologics Market – By Geography

North America

U.S.

Canada

Mexico

Europe

U.K.

France

Germany

Italy

Rest of Europe

Asia-Pacific

Japan

China

India

Australia

Rest of Asia Pacific

ROW

Latin America

Middle East

Africa

New Business Strategies, Challenges & Policies are mentioned in Table of Content, Request TOC at @ https://www.decisionforesight.com/toc-request/DFS020111

Geographic Analysis:

North America is expected to dominate the global biologics market in terms of market share during the forecast period. The presence of key market players, continuous R&D in the biologics field, growing prevalence of chronic disorders, and longer patent protection compared to other regions are the major factors attributing to the market dominance of the region. For instance, U.S. pharmaceutical companies’ account for almost 80% of the world’s R&D in health care biotechnology. The Asia Pacific region is anticipated to witness the fastest growth in the biologics market during the forecast period. Expansion of international players in developing nations contribute to the biologics market growth in the APAC region. For instance, Novartis AG wishes to launch its FDA approved treatment Kymriah in Japan. Additionally, there has been a spurt of heavy investments by Asian contract manufacturers in order to grab share in the global biologics market. Companies such as Samsung Biologics and Wuxi Biologics are anticipated to drive the market growth in the Asian region.     

Competitive Scenario :

The key players operating in the global biologics market are –

AbbVie Inc., Amgen Inc., Pfizer Inc., Novartis AG, GlaxoSmithKline Plc, Bayer AG, Sanofi, Hoffman La-Roche, Samsung Biologics, Eli Lilly & Company, Merck & Co., Johnson & Johnson Services Inc.   

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[rohinic123-blog]

Age-related Macular Degeneration Market Opportunity Assessment and Forecast up to 2025

Age-related macular degeneration is also called macular degeneration, ARMD, or AMD. AMD is a disease of retina that blurs the sharp central vision, which is important for various activities that involve looking straight ahead such as driving, using computer, watching television, sewing, and reading. In AMD, a part of retina called macula, which allows seeing fine details, is affected. AMD is a chronic eye disease that does not cause pain. It is mostly observed in patients aged above 50 years. AMD is a major cause of vision loss amongst the elderly people in the U.S. Rising geriatric population in the U.S. and other countries is expected to increase the prevalence of AMD significantly in the next few years. The disease is more prominent in developed countries and it accounts for 8.7% of blindness all over the world.

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AMD is of two kinds viz. wet macular degeneration and dry macular degeneration. The first kind of AMD is more severe. It causes abnormal progression of blood vessels in the damaged part of macula, which damages the retinal vision. Though AMD is associated with aging, the research proposes that there also exists a genetic component to the disease. Scientists at Duke University (North Carolina, the U.S.) and other scientists have identified a strong relationship between AMD development and existence of gene variants such as complement factor H (CFH). Deficiency of the CFH gene is associated with nearly 50% of all potentially blinding cases of AMD. Researchers at the University of Columbia Medical Center and other researchers have identified that variants of an additional gene, complement factor B, may be involved in the AMD development. In around 74% of AMD patients that were studied, a specific variant of these genes has been found, which plays a key role in immune responses of the human body. At present, no treatment exists for dry AMD; however, existing therapies can delay the development of visual impairment and wet AMD.

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The market for AMD is driven by increasing number of AMD patients throughout the world. According to the American Academy of Ophthalmology, in the U.S., around 11 million patients are affected by AMD and the prevalence of AMD is high in countries in Southeast Asia and sub-Saharan Africa, due to deficiency of vitamin A in these countries.

Growing reimbursement benefits for AMD drugs is another major driver for the age-related macular degeneration market. Depending on regular cost of the drug, Medicare postulated a National Reimbursement Rate in the U.S. In this condition, the agency pays almost 80% of the cost of bevacizumab and ranibizumab injections and the remaining 20% of the cost is co-paid. Medicare part B is a medical insurance, which includes insurance for eye diseases and diagnostic tests that also covers specific treatment conditions such as AMD. Lack of trained ophthalmologists, high cost of drugs for wet AMD, and associated high risk are some major challenges before the AMD market.

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The age-related macular degeneration market can be broadly categorized on the basis of type of AMD, type of drug, route of administration, and geography. Based on type of AMD, the market can be segmented into wet AMD and dry AMD. Based on type of drug, it can be divided into Lucentis, Eylea, Avastin, Visudyne, and others. Based on route of administration, the market has been segmented into IV and intravitreal. Based on geography, the global AMD market can be divided into four regions viz. North America, Asia Pacific, Europe, and Rest of World.

Major players operating in the age-related macular degeneration market are Genentech, Inc. (a member of Roche Group), Pfizer, Inc., Valeant Pharmaceuticals International, Inc., Regeneron Pharmaceuticals, Bayer Healthcare (a subsidiary of Bayer AG), and Novartis AG.

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The report offers a comprehensive evaluation of the market. It does so via in-depth qualitative insights, historical data, and verifiable projections about market size. The projections featured in the report have been derived using proven research methodologies and assumptions. By doing so, the research report serves as a repository of analysis and information for every facet of the market, including but not limited to: Regional markets, technology, types, and applications.

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[healthcare-market]

Monoclonal Antibodies Market Growth to be Fuelled by Advancements in Technology

Global Monoclonal Antibodies Market: Overview

Antibodies, which are proteins generated by plasma cells in response to specific antigens, is used for diagnostic and therapeutic purposes. Monoclonal antibodies (mAbs), a type of mono-specific antibodies, are comprised of identical antibody molecules and are produced by a single clone of cells or cell line. Monoclonal antibodies have brought about a fundamental change in pharmaceutical and biotechnology sectors and in the future too are slated to play a crucial role in clinical protocol with further development of these molecular agents. Monoclonal antibodies find application in the treatment of a variety of diseases, particularly autoimmune, cancer, and inflammatory diseases.

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The global monoclonal antibodies market is characterized by the presence of numerous global and regional players and is dynamic in nature. The well-entrenched players compete with the local ones on the basis of technology, cost, and product differentiation. Buying into the promise of robust growth in the future, more players will likely try and foray into the market. However, strict guidelines surrounding the manufacture of mAbs may act as a deterrent.

The report provides a detailed analysis of the opportunities and trends in the global monoclonal antibodies market. It segments the global market based on different parameters in order to study them in depth with expert inputs from industry veterans. The report provides a detailed assessment of the prevailing vendor landscape. It also profiles the leading players operating in the market and leveraging industry-leading analytical tools, gauges the threats and opportunities that these companies may face over the course of the forecast period between 2016 and 2024.

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Global Monoclonal Antibodies Market: Trends and Opportunities

Driving the growth of the global monoclonal antibodies market is the increasing prevalence of cancer and other chronic diseases. Such maladies have resulted in soaring demand for biologics, which in turn is leading to the demand for monoclonal antibodies. Rising thrust on research and development activities in genomics alongside the emergence of technologically advanced genetic platforms, such as next generation sequencing, have also majorly contributed to the market. In addition, the affordability of the technology needed for research to develop mAbs has also contributed to the growth in the market.

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Other factors positively impacting the market are rising awareness among patients and physicians regarding applications of mAb therapy, unveiling of better products every now and then, growing adoption of therapeutic antibodies in cost-sensitive markets, and quick approval by regulatory authorities for breakthrough therapies. Going forward, swift approvals of blockbuster mAbs for different indications, is further slated to up their usage. For example, popular drugs such as Herceptin, Avastin, Rituxan, and Remicade on the back of FDA approval for treating Crohn's disease, cancer, rheumatoid arthritis, ulcerative colitis, etc. would further boost the market.

One drawback of drugs formulated from mAbs is that they are very specific in nature and have limited targets. This is because they just interact with cells and do not penetrate them. This to some extent has hampered the global monoclonal antibodies market. Another difficulty in using mAbs is that they need to be injected unlike small molecule drugs.

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Global Monoclonal Antibodies Market: Regional Outlook

Geographically, the global market for monoclonal antibodies can be segmented into Europe, North America, Asia Pacific, and the Rest of the World. Among them, North America holds a dominant position in the market on account of the presence of well-established healthcare infrastructure, increased emphasis by the government for infection control and management, and increasing prevalence of lifestyle-related diseases. In the near future, the market will continue on its upward trajectory due increased funding by the government for cancer research and technology development.

Going forward, Asia Pacific is also predicted exhibit considerable growth owing to rising spending power of the people in the region along with increasing spend on research and development and growing patient awareness pertaining to the therapeutic use of mAbs. By dint of being underpenetrated too, the Asia Pacific market holds out a promise of robust growth.

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Companies Mentioned in Report

To present an in-depth assessment of the competition prevailing in the market, the report profiles companies such as Roche, Eli Lilly, Genentech, Pfizer, and Biogen Idec. The report not just profiles such leading players, but also brings to the fore their strengths and weaknesses.

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[pharmaphorumuk]

Roche claims EU okay for Herceptin/Perjeta combination Phesgo

Roche has secured EU approval for Phesgo, a fixed-dose combination of its breast cancer drugs Herceptin and Perjeta that is easier and cheaper to administer to patients – and also provides a defence against biosimilar competition.

Phesgo combines the anti-HER2 antibodies in Herceptin (trastuzumab) and Perjeta (pertuzumab) in a subcutaneous injection that takes a few minutes to deliver.

At the moment, Herceptin is available as a subcutaneous injection but Perjeta needs to be delivered by intravenous infusion – a process that takes hours – and Roche says that means Phesgo is preferred by both patients and doctors and also reduces the cost of treatment.

Phesgo has been approved by the EU for same indications as Herceptin/Perjeta – in combination with chemotherapy in early HER2-positive breast cancer (pre- and post-surgery) as well as for front-line therapy of HER2-positive breast cancer that has already spread in the body.

The drug was cleared by the FDA in June for the US market and made CHF 7 million (almost $8 million) in preliminary sales in the third quarter, with Roche still in the process of securing formulary approvals.

That’s a drop in the ocean compared to the CHF 1.5 billion and CHF 910 million in Herceptin and Perjeta sales, respectively, in the same period, but with Phesgo Roche is looking to the future.

Herceptin sales dropped a third in the first nine months of the year due in part to the pandemic but mainly the impact of low-cost biosimilars, although Perjeta remains in-patent for the next few years and is growing fast – thanks largely to data from the APHINITY trial which showed that adding it to Herceptin can improve disease-free survival in early-stage breast cancer.

That makes Perjeta a particularly important part of Roche’s product range, particularly as two of its other big-selling antibodies – Avastin (bevacizumab) and Rituxan/MabThera (rituximab) – are also being hit by biosimilar competition.

As many patients with HER2-positive breast cancer received the drug in combination with Perjeta, the convenience of Phesgo is a big draw – patients can be in and out of clinic in 30 minutes rather than three hours or more.

It remains to be seen of course whether payers can be convinced to plump for the new drug over biosimilar trastuzumab plus Perjeta, allowing the drug to mitigate the impact of Herceptin biosimilars on Roche’s HER2 franchise.

“The innovation of Phesgo significantly reduces the time people spend receiving standard of care therapy with Perjeta and Herceptin, helping to minimise the impact of treatment on their everyday lives,” said Levi Garraway, Roche’s chief medical officer.

“It also addresses the increasing demand across healthcare systems for faster and more flexible treatment solutions.”

After the US approval, Piper Sandler analyst Joseph Catanzaro said that Phesgo could be an underappreciated blockbuster product that will be a growth driver for Halozyme, the company that provided the drug delivery technology that underpins the new product.

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[coolluminaryland-blog1]

CNV (Choroidal NeoVascularization) Market to Surge at a Robust Pace by 2023

Choroid is the part of eye that lies in between the retina (vision sensory area) and the sclera (the outer layer of the eye), this area consist of blood vessels that supply nutrients to the retinal part of our eye. Choroidal NeoVascularization (CNV) is a disease, which is characterized by the formation of new blood vessels that arise either due to the presence of Vascular Endothelial Growth Factors (VGEF) or due to Age-related Macular Degeneration (AMD). This results in fluid accumulation below the retinal pigment epithelium, which can lead to vision loss or extreme myopic vision among individuals. CNV is also seen in individuals with diabetic retinopathy. In rare cases, it can occur among individuals with defects in Bruch’s membrane, the innermost layer of the choroid. It has also been observed by the American Academy of Ophthalmology and other reports that patients with CNV in one eye have a very high probability to contract CNV in the other eye within a short frame of time.

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According to the British Journal of Ophthalmology published in 2007, age?related macular degeneration (AMD) is one of the leading causes of irreversible sight loss among adults registered as legally blind. Among these, two-thirds of people with AMD have the wet form, which can progress quickly causing irreversible sight loss within days or weeks. In 2007, approximately 250,000 people were suffering from neovascular AMD in the U.K, with an incidence rate of 25,000 and 30,000 new cases annually.

The only successful treatment option that is available commercially in the market for CNVs include intravitreal (direct to the eye) injections of anti-VEGF drugs to control the neovascularization and reduce the fluid accumulated. The most common anti-VGEF compounds are Ranibizumab (Trade name: Lucentis), Bevacizumab (Trade name: Avastin) and the novel drug Pegaptanib (Trade name: Macugen). These drugs belong to a class called anti-angiogenic drugs, their primary objective being the inhibition of the growth of new blood vessels. Anti angiogenic drugs are more commonly used for cancer treatment, where cancerous cells promote angiogenesis resulting in the proliferation of cells in large numbers, thus forming tumors. Bevacizumab is a successfully used cost effective drug for the treatment of cancer as well as AMD related CNVs with a very high half life (more than twice) in comparison with Ranibizumab. However chances of adverse effects with Bevacizumab are comparatively higher, hence Ranibizumab (Lucentis) is now currently the most effectively and safely used treatment for CNV. Pegaptanib on the other hand is in Phase IV of the clinical trials wherein only 1000 patients so far have been treated with significant success rate.

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With increasing aging population throughout the world the probability of occurrence of wet-AMD is high, especially in China and Japan where the aging population is predicted to tip over the young adult population. The patents for both Bevacizumab and Ranibizumab are till 2018 hence after patent expiry it is predicted that their sales shall significantly increase, especially with the entrance of Asian drug manufacturers.

Currently the companies that manufacture Ranibizumab are Novartis (licensed) in global market and Genetech (patented) in the U.S. Bevacizumab too was developed by Roche Pharma in association with Genentech and is currently marketed by Roche internationally. Pegaptanib is manufactured by Eyetch Inc. and marketed by Pfizer Inc.

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Pegaptanib has been approved and is available only in North America, Europe, Brazil and Australia. Ranibizumab is available under the name Lucentis with high market share in Europe and North America and growing in Asia-Pacific region. Bevacizumab is sold as Avastin globally with highest growth rate observed in Asia and highest voluminous growth seen in the North Americas and European markets.

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[todaynewsstories]

UK doctors win battle with drug giants over cheaper eye medicine

ZURICH (Reuters) – Drug giants Novartis, Bayer and Roche on Friday lost a bid to stop British doctors from recommending a cheaper drug option for people with an eye disease that causes blindness, the High Court in London ruled.

A drug industry group said the decision was “extraordinary” and was bad news for future regulatory cooperation between Britain and the European Union after Britain’s exit from the bloc next year.

The companies had sought to block doctors from 12 health groups in the north of England from making Roche’s cancer therapy Avastin the preferred option for wet age-related macular degeneration (AMD), even though it is not licensed for this use.

Avastin works similarly to Bayer’s Eylea and Roche’s and Novartis’s Lucentis, but those drugs were made specifically for the eye.

“Treating clinicians can lawfully choose Avastin for opthalmic use on grounds of cost,” according to the ruling. It added that NICE, the UK’s drug cost effectiveness agency, had concluded that using Avastin for AMD was safe.

Avastin costs around 28 pounds ($37) per injection, according to the judgment, while Eylea costs around 816 pounds per injection and Lucentis costs around 551 pounds per injection. The actual prices vary, however, based on confidential discounts.

Bayer said it was disappointed, adding the ruling puts up roadblocks for companies trying to develop new medicines if off-label uses of older drugs win official sanction.

“Bayer is currently considering all of its options, including the possibility of an appeal,” it said.

While Roche makes Avastin, it wants to sell the more expensive Lucentis for eye patients and said prescribing medicines for off-label use merely based on cost was illegal.

“We believe the unapproved use of medicines for purely economic reasons breaches established laws governing the unapproved or unlicensed use of medicines,” according to a statement from the Basel-based company.  

UK drug industry lobby ABPI said it would examine the ruling carefully. “This extraordinary judgment potentially undermines the regulation of all medicines and by doing that, neither patients nor doctors have clarity on what information to trust.”

Eylea and Lucentis, like Avastin, reduce new blood vessel growth that contributes to AMD, which occurs when the macula is unable to function properly.

Bayer and Novartis have argued Avastin had not undergone the same regulatory scrutiny for use in AMD as Lucentis and Eylea.

The doctors group has said using Avastin rather than Eylea or Lucentis could save the regional National Health Service (NHS) 13.5 million pounds a year. Across England, savings from using Avastin could total more than 500 million pounds, the British Medical Journal has reported.

According to the policy sought by the doctors, patients will be told Avastin is the preferred choice, although they are still free to choose Eylea or Lucentis.

($1 = 0.7606 pounds)($1 = 0.8516 euros)

Reporting by John Miller in Zurich, Kate Kelland in London and Ludwig Burger in Frankfurt

Our Standards:The Thomson Reuters Trust Principles.

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[fitnesswomenshealth-blog]

NHS to save 'hundreds of millions' in landmark drug ruling

New Post has been published on https://cialiscom.org/nhs-to-save-hundreds-of-millions-in-landmark-drug-ruling.html

NHS to save 'hundreds of millions' in landmark drug ruling

Image copyright Olga Ignatova

Impression caption Moist age-related macular degeneration has an effect on close to 26,000 folks in the Uk

A landmark ruling against two top drug corporations could conserve the NHS “hundreds of tens of millions” a yr.

The situation centred on the treatment of people with the eye situation, wet age-relevant macular degeneration (AMD).

Twelve NHS bodies in the north east of England had been giving sufferers the drug Avastin, a more affordable option to the certified drug, Lucentis.

Well being bosses said the ruling may reduce the ability of businesses to correct costs.

Drug business Novartis explained they ended up “deeply let down” due to the fact people were getting asked to settle for an unlicensed procedure to help save the NHS revenue.

David Hambleton, main govt officer of NHS South Tyneside scientific commissioning group (CCG), 1 of the NHS teams included in the circumstance, welcomed the judgment, expressing it was a great working day for people and the NHS.

“We’ve normally explained we consider that it truly is vital that people ought to have the alternative of a quite helpful cure for damp AMD, and it is actually a fraction of the price of the other solutions.

“So I believe what we do now is give clients that option. We think that they will aid incredibly strongly owning a charge-successful, secure treatment method and saving the NHS commonly a whole lot of revenue. It is a victory for frequent sense around industrial passions.”

What was the dispute?

The scenario was introduced by pharmaceutical giants Bayer and Novartis towards twelve NHS CCGs in the north of England.

The NHS groups ended up giving sufferers a choice involving Lucentis and Eylea – medication certified for eye cure – and the considerably less costly drug Avastin, which is proposed by the Earth Well being Organisation (WHO) for managing eyes, but only certified for most cancers treatment in the Uk.

Bayer and Novartis manufacture the two more high priced accredited prescription drugs – Lucentis which costs £561 and Eylea which prices £800.

By comparison, Avastin prices about £28 for each injection.

Avastin is extensively utilised close to the entire world, particularly in the US, but Novartis – which distributes the drug in the British isles – has not sought a licence for this drug for treating AMD.

In January, the Nationwide Institute for Health and Treatment Excellence (Awesome) concluded that Avastin was as protected and powerful as the two accredited prescription drugs, Lucentis and Eylea.

Mike Load, President of the Royal Higher education of Ophthalmologists stated: “Licensing regulations are designed to secure individuals from poorly controlled unproven prescription drugs, but it is the drug companies’ obligation to utilize for a licence.

“It is not surprising that Novartis was unwilling to license Avastin for use in the eye, mainly because it is building a excellent offer of funds charging appreciably a lot more for Lucentis.

“We are dealing with 40,000 new diagnoses of soaked AMD every year – the saving could amount of money to £500 million a yr. This quantities to 1 district healthcare facility currently being constructed each year.”

What is AMD?

Age-associated macular degeneration (AMD) is an eye problem that influences much more than 600,000 individuals, 26,000 of those people undergo from wet AMD

It results in individuals to lose central eyesight, usually in both equally eyes

It is a lot more popular with age and there are two primary kinds – moist AMD and dry AMD

Looking at becomes extra tricky, colors seem considerably less vibrant and faces can be difficult to recognise

Moist AMD develops when abnormal blood vessels sort and injury the cells at the again of the eye

Moist AMD can be dealt with if caught early. Drugs are injected into the eye to quit the development of the abnormal blood vessels

Image copyright SIphotography

Impression caption Wet AMD can be treated with injections

David Hambleton, of NHS South Tyneside CCG, explained the ruling would result in a rethink for Great and the MHRA, the UK’s drug regulatory entire body.

“I believe at minimum we have bought some true lawful clarity now, so equally of the bodies – Wonderful and the MHRA – will need require to seem at what their assistance states.

“Now they have the possibility of allowing the use of so-termed ‘off-label’ medicine.”

Responding to the ruling, a spokesperson from pharmaceutical organization Novartis claimed: “Novartis is deeply let down in this final decision and continues to be of the feeling that the plan undermines the effectively-established lawful and regulatory framework that is there to protect both patients’ security and to guarantee wellness treatment specialists can prescribe with self-confidence.”

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