#Dolutegravir market production

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Dolutegravir Prices | Pricing | Trend | News | Database | Chart | Forecast

Dolutegravir is an antiretroviral medication primarily used in the treatment of HIV/AIDS. As part of the class of drugs known as integrase inhibitors, Dolutegravir works by blocking the action of an enzyme called integrase, which the HIV virus uses to replicate. Since its approval by the U.S. Food and Drug Administration (FDA) in 2013, Dolutegravir has become a crucial component in many HIV treatment regimens. However, one of the most significant concerns around the world, especially in low-income and middle-income countries, has been the pricing of Dolutegravir. Pricing influences access to this essential medication, and efforts are ongoing to make it more affordable for those who need it most.

The cost of Dolutegravir varies widely depending on geographic location, patent laws, and whether the drug is branded or generic. In high-income countries such as the United States, Dolutegravir is often sold under the brand name Tivicay, manufactured by ViiV Healthcare. The brand-name version of Dolutegravir tends to be expensive, with prices in the U.S. being notably higher than in other regions. For example, a month's supply of Tivicay can cost thousands of dollars. This high cost is driven by research and development expenses, regulatory costs, and the need to recoup the investment in bringing a new drug to market. However, the high cost in wealthier nations often makes it difficult for those without adequate health insurance or government assistance to access the medication.

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In contrast, many low- and middle-income countries rely on generic versions of Dolutegravir, which are significantly less expensive. Generic Dolutegravir became available after licensing agreements and patent waivers were negotiated between pharmaceutical companies, non-governmental organizations, and international agencies. These agreements allowed for the production of more affordable versions of the drug, making it accessible to larger populations. In countries such as India, which has a robust generic pharmaceutical industry, the price of Dolutegravir can be as low as a few dollars per month. This drastic reduction in price has been crucial in improving access to HIV treatment, particularly in regions that are heavily burdened by the epidemic, such as sub-Saharan Africa.

Global health organizations like the World Health Organization (WHO) and the Joint United Nations Programme on HIV/AIDS (UNAIDS) have played a pivotal role in advocating for lower prices for HIV medications, including Dolutegravir. The Medicines Patent Pool (MPP) is another initiative that has helped to lower the cost of Dolutegravir. By facilitating voluntary licensing agreements, the MPP enables generic drug manufacturers to produce and sell Dolutegravir at a fraction of the price of the branded version. These efforts have resulted in broader availability of the drug, but challenges remain in ensuring that everyone who needs Dolutegravir can afford it.

The introduction of Dolutegravir as part of first-line HIV treatment regimens in many countries has been a game-changer. Not only is Dolutegravir highly effective in suppressing the HIV virus, but it also has a high barrier to resistance, meaning that patients are less likely to develop resistance to the drug over time. Moreover, Dolutegravir has fewer side effects compared to older antiretroviral medications, making it a preferred option for many patients and healthcare providers. Given its effectiveness, there has been a global push to make Dolutegravir the standard of care in HIV treatment. However, pricing remains a barrier in some parts of the world, where even the generic versions may be out of reach for the most vulnerable populations.

Efforts to reduce the price of Dolutegravir are ongoing, with various international partnerships and coalitions working to negotiate lower costs. For example, the Global Fund to Fight AIDS, Tuberculosis and Malaria has been instrumental in securing lower prices for Dolutegravir through bulk purchasing agreements. These agreements allow for large quantities of the drug to be purchased at a reduced cost, which can then be distributed to countries in need. Additionally, some countries have implemented pricing controls or subsidies to make Dolutegravir more affordable for their populations. These strategies have been successful to varying degrees, depending on the political and economic landscape of each country.

Another factor influencing the price of Dolutegravir is the expiration of patents. As patents on the drug begin to expire in more countries, the opportunity for increased competition among generic manufacturers grows. This competition is expected to drive prices down even further, making Dolutegravir more accessible to a wider range of people. However, patent expirations are staggered across different regions, meaning that some countries may experience price reductions sooner than others. In countries where the patent is still in effect, advocacy efforts are focused on encouraging pharmaceutical companies to voluntarily lower their prices or enter into more licensing agreements that would allow for the production of generics.

In recent years, there has been a growing emphasis on the importance of affordable HIV treatment as part of global health initiatives. The United Nations has set ambitious goals for reducing the number of new HIV infections and ensuring that those living with HIV have access to treatment. Dolutegravir is central to these efforts, but its price remains a critical issue. Without continued pressure on pharmaceutical companies and governments, there is a risk that some populations will continue to be left behind in the fight against HIV/AIDS.

In conclusion, the pricing of Dolutegravir reflects a complex interplay of factors, including patent laws, production costs, and global health policies. While progress has been made in making the drug more affordable, particularly in low- and middle-income countries, there is still work to be done to ensure that everyone who needs Dolutegravir can access it. The future of HIV treatment depends not only on the development of new and effective medications but also on the ability to make these treatments affordable and accessible to all. Through continued international cooperation and advocacy, it is possible to further reduce the price of Dolutegravir and ensure that it reaches those who need it most.

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Industrially produced citric acid CAUSES CANCER!

In 1919 PFIZER began the industrial production of citric acid, followed by Citrique Belge in 1929. Industrially produced citric acid is carcinogenic! Citric acid is one of the active ingredients in the production of antiviral tissues. The refractive index of sugar and citric acid is almost identical. Factory-produced Citric Acid is a preservative used as an additive in soft drinks, jams, cheap wines, fruit sweets, various types of ice cream and chips, sports drinks, mozzarella cheese and energy drinks. This carcinogenic substance is in diet coke and citric acid is added to soft drinks in fairly high concentrations. Citric acid is in beer and Seltzer, jam, fruit sweets, various types of ice cream and chips, sports drinks and energy drinks. Pfizer is now one of the largest drugmakers in the world, producing Viagra and the 'vaccine' against COVID, among other things. Pfizer is also adept at exerting its considerable political influence to protect its interests; Pfizer is the 6th largest lobbier in Washington and spent $25 million on lobbying during the passage of Obama's health care reform legislation alone. It produces biologics in every clinical field, up to stem cells and consumer goods. The pharmaceutical monster Pfizer donates AIDS drugs to both poor communities in the U.S. and to developing countries. Bill Gates guarantees minimal sales volumes of the AIDS drugs with dolutegravir, a so-called integrase inhibitor that avoids the drug resistance that often arises with older treatments (!) In 2009, Pfizer faced more than $2 billion in legal settlement payments over drug marketing practices and announced it would close a large number of manufacturing and R&D locations worldwide. Citric acid is one of the chemicals needed for the synthesis of HMTD, a highly heat, friction and shock sensitive explosive similar to acetone peroxide. Large amounts of citric acid may raise suspicions of possible terrorist activities. ADI: acceptable daily intake, the amount that one can take of a certain substance over the life cycle without health risk. Based on toxicological studies, the safe dose and ADI have not been established. The ADI values do not sufficiently protect children up to the age of 12. Would you like to avoid as much citric acid as possible from your diet? Some tips: * Never choose artificial foods, ready-to-eat foods, or highly concentrated foods. * Choose fresh, intact, organic and natural as much as possible * Opt for really freshly squeezed lemon juice, instead of ready-made. Sources: Mike Adams, David and Elizabeth Wilcock https://inchem.org/documents/jecfa/jeceval/jec_436.htm andhttps://moniquevandervloed.nl/is-citroenzuur-en-is-schadelijk/#citric_acid #cancer #bill_gates #Pfizer_gate #Pfiser #pfizer #kankerverwekkende_stof #kanker #CN_codes_2918_1400_and29181500 #tienen #additieven #Bill_Gates #pfizerleaks #pfizer #citroenzuur #PFIZERgate #citrique_belge #carcinogeen

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Dolutegravir Market Key Trends, Drivers, Growth Opportunities, and 2025 Industry Chain Structure Analysis

The research study Dolutegravir market 2020 launched by ABRReports.com provides the detailed analysis of current market status, investment plans, production and consumption, price trends, leading key companies, growth drivers and future prospect. The base year considered for the study is 2019, and the market size is projected from 2020 to 2025

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 The segmentation of Dolutegravir study as mentioned below:

By Market Players:

ViiV Healthcare (GSK), Shanghai Desano Pharmaceuticals, Mylan, Aurobindo Pharma, LAURUS Labs, Adcock Ingram Limited

 By Application

Prevent HIV Infection Following Potential Exposure, Other10mg Tablets, 50mg Tablets

 The points that are discussed within the report are the major market players that are involved in the market such as manufacturers, raw material suppliers, equipment suppliers, end users, traders, distributors and etc. The complete profile of the companies is mentioned. And the capacity, production, price, revenue, cost, gross, gross margin, sales volume, sales revenue, consumption, growth rate, import, export, supply, future strategies, and the technological developments that they are making are also included within the report. The historical data from 2014 to 2019 and forecast data from 2020 to 2025.

 The growth factors of the market are discussed in detail wherein the different end users of the market are explained in detail. Data and information by manufacturer, by region, by type, by application and etc, and custom research can be added according to specific requirements. The report contains the SWOT analysis of the market. Finally, the report contains the conclusion part where the opinions of the industrial experts are included.

 Click to access full report and Table of Content at https://www.abrreports.com/industry-insights/2020-2025-global-and-regional-dolutegravir-industry-production-sales-and-consumption-status-and-prospects-professional-market-research-report

 The key objective of this report is to help the user understand the market in terms of its definition, segmentation, market potential, influential trends, and the challenges that the market is facing. Deep researches and analysis were done during the preparation of the report. The readers will find this report very helpful in understanding the market in depth. The data and the information regarding the market are taken from reliable sources such as websites, annual reports of the companies, journals, and others and were checked and validated by the industry experts. The facts and data are represented in the report using diagrams, graphs, pie charts, and other pictorial representations. This enhances the visual representation and also helps in understanding the facts much better.

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 Key pointers of the Table of Contents:

Chapter 1 Industry Overview

Chapter 2 Major Segmentation (Classification, Application and etc.) Analysis

Chapter 3 Production Market Analysis

Chapter 4 Sales Market Analysis

Chapter 5 Consumption Market Analysis

Chapter 6 Production, Sales and Consumption Market Comparison Analysis

Chapter 7 Major Manufacturers Production and Sales Market Comparison Analysis

Chapter 8 Marketing Channel Analysis

Chapter 9 Industry Chain Analysis

Chapter 10 Global and Regional Market Forecast

Chapter 11 Major Manufacturers Analysis

Chapter 12 New Project Investment Feasibility Analysis

Chapter 13 Conclusions

Continued…

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[wealthzi]

Vijaya Diagnostic, Ami Organics IPOs open; Should you invest?

Two IPOs have hit the street on monday, with Hyderabad based Vijaya Diagnostic and Gujarat based Ami Organics seeking to raise a combined sum of about Rs 2,500 crore. Amid the stock markets hitting new highs every day, the IPO mania continues in full swing. Here are all the details you wanted. 1. Vijaya Diagnostic Vijaya Diagnostic Centre Limited (“VDCL”) was incorporated on June 5, 2002. VDCL is the largest integrated diagnostic chain in southern India, by operating revenue, and also one of the fastest growing diagnostic chains by revenue for fiscal year 2020. VDCL offers an one-stop solution for pathology and radiology testing services to their customers through their extensive operational network, which comprises 80 diagnostic centres and 11 reference laboratories across 13 cities and towns in the states of Telangana; Andhra Pradesh; the National Capital Region and Kolkata.  

Vijaya Diagnostic is offering IPO shares in the price band of Rs 522 to Rs 531 per share. The face value of shares is Re 1. The implied market cap at issue price is about Rs 5,400 crore. The issue opens on September 1 and closes on September 3. The lot size for IPO application is 28 shares, which means the minimum investment is Rs 14,868. The IPO shares will be listed around September 14.  The IPO is an offer for sale of Rs 1,895 crore. The objects of the offer are to (i) carry out the OFS of up to 35,688,064 equity shares by selling shareholders; (ii) achieve the benefits of listing the equity shares on the stock exchanges. At the upper band of Rs 531, the Vijaya Diagnostic IPO is valued at P/E of 64 times its FY21 EPS of Rs 8.26. Here is what top brokers have to say about Vijaya Diagnostic IPO. IIFL Securities:  “At the upper price band, Vijaya Diagnostic Centre Limited valuation is lower than the industry average of 90.8 times. Considering the future growth potential of healthcare industry, revenue from operation, EBITDA and PAT growth of 13.5%, 23.9% and 35.5% CAGR during FY19 to FY21, respectively, strong ROE and ROCE of 23.64% and 42%, respectively in FY21, debt-free company with plans for acquisition and expansions, diversified service offerings and strong technical capabilities of the company, we recommend ‘Subscribe’ to the issue with a long-term perspective.” KR Choksey: ” Vijaya has consistently posted strong performance in terms of operating growth and profitability in last few years. Revenues have grown at a CAGR of 13.5% over FY19-21 to Rs 377 crore. VDCL’s ‘hub and spoke’ model has provided economies of scale and cost optimization benefits, resulting in EBITDA growth of 23.9% and even stronger 35.5% growth in PAT over FY19-21. Integrated network and high B2C business has translated into higher cash flow conversion. Company also recorded strong return on net worth of 23.64% and return on capital employed (pre cash) of 42.00% during FY21.” 2. Ami Organics IPO Ami Organics Limited is a research and development (“R&D”) driven manufacturer of specialty chemicals with varied end usage, focussed towards the development and manufacturing of advanced pharmaceutical intermediates (“Pharma Intermediates”) for regulated and generic active pharmaceutical ingredients (“APIs”) and New Chemical Entities (“NCE”) and key starting material for agrochemical and fine chemicals, especially from their recent acquisition of the business of Gujarat Organics Limited (“GOL”)(“Acquisition”). They are one of the major manufacturers of Pharma Intermediates for certain key APIs, including Dolutegravir, Trazodone, Entacapone, Nintedanib and Rivaroxaban. The Company have developed and commercialised over 450 Pharma Intermediates for APIs across 17 key therapeutic areas since inception and NCE, with a strong focus on R&D across select high-growth high margin therapeutic areas such as anti-retroviral, anti-inflammatory, anti-psychotic, anti-cancer, anti-Parkinson, antidepressant and anticoagulant, for use across the global pharmaceutical market. Their Pharma Intermediates used for manufacturing of APIs and NCEs portfolio has expanded from over 425 products as of March 31, 2019, to over 450 products as of March 31, 2021.

Ami Organics is offering IPO shares in the price band of Rs 603 to 610 per share. The face value of shares is Rs 10. The issue opens on September 1 and closes on September 3. The lot size for IPO application is 24 shares, which means the minimum investment is Rs 14,640. The IPO shares will be listed around September 14.  The Ami Organics IPO comprises a fresh issue of Rs 200 crore for repayment/prepayment of certain financial facilities availed, funding working capital requirements and general corporate purposes. The other IPO component is the OFS of Rs 369.6 crore where the company will not receive any proceeds from.   With an EPS of Rs 17.14 as of 31st March 2021, the issue is priced at 35.59 times calculated at the upper price band of Rs 610 per share. The P/BV is 11.51 at a NAV of Rs 52.99 per share. Here is what top brokers have to say about Ami Organics IPO.

Anand Rathi: “The company has shown consistent financial performance with sales growth at CAGR of 19.5% and restated profit after tax growth at CAGR of 52.3% between the Fiscals 2019 and 2021. The financials for 2020- 21 doesn’t include revenue from the acquisition of the two plants. We are positive on the long-term prospects of the Company. Hence, we recommend a “Subscribe” rating to this IPO.” Marwadi Financial Services: “The competitive strengths of the company are strong and diversified product portfolio ably supported by strong R&D and process chemistry skills. Extensive geographical presence and diversified customer base with long standing relationships. High entry barriers in the chemicals manufacturing industry in which the Company operates. Strong sales and marketing capabilities. Experienced and dedicated management team. Consistent financial performance.”  

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Sexually Transmitted Diseases (STDs) Treatment Market Forecast Analysis-2027

Sexually Transmitted Diseases Treatment market - Regional Analysis

Geographically, the Sexually Transmitted Diseases Treatment Market is segmented into North America, Latin America, Europe, Asia Pacific, Middle East, and Africa. North America is expected to be dominant market, owing to rising government initiative for disease awareness and implementation of prenatal screening programs. However, Asia Pacific is expected to be fastest growing market for sexually transmitted diseases treatment, due to high incidence of sexually transmitted infections, owing to unprotected sexual practices in the region. For instance, according to Joint United Nations Programme on HIV and AIDS (UNAIDS), Asia Pacific had the second-highest number of people living with HIV in the world i.e. 5.1 million as of 2016, Moreover, China, India, and Indonesia accounts for three quarters of the total people living with HIV in Asia Pacific.

Sexually transmitted disease also known as venereal diseases is a clinical syndrome of infection, acquired and transmitted through sexual activity via body fluids such as semen, vaginal fluid or blood. Causative agent of STD are bacteria, parasites, yeast, and viruses. Symptoms of STDs includes skin rashes, warts, abdominal pain or genital ulcers. STDs are detected by physical examination or assays such as ELISA (Enzyme Linked Immunosorbent Assay), rapid plasma reagin blood test or antibody-absorption blood test. The sexually transmitted disease treatment market is expected to witness high growth in the forecast period (2017 – 2025), due to the factors such as increasing disease burden, governmental initiatives for increasing awareness, growing diagnosis of sexually transmitted diseases, and increasing number of pipeline products by manufacturers for treatment of these diseases.

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Sexually Transmitted Diseases Treatment market – Driver

Increasing sexually transmitted disease burden is fueling growth of the STDs treatment market. Among 20 STDs, the most common are Gonorrhea, Chlamydia, Syphilis, Herpes, Hepatitis (HBV), and Human Immunodeficiency Virus (HIV). For instance, according to Centers for Disease Control and Prevention (CDC), in year 2016, 1,598,354 cases of Chlamydia trachomatis infection were reported in the U.S., corresponding to 497.3 cases per 100,000 in 2015. Furthermore, 468,514 gonorrhea cases were reported for a rate of 145.8 cases per 100,000 population, an increase of 18.5% from 2015. This increasing incidence of STDs is also due to the unprotected sexual practice, which in turn fueling demand for STDs treatment. For instance, according to World Health Organization (WHO), unsafe sex is second most common risk factor for increasing disease burden.

The number of products in pipeline for HIV treatment are high, which is expected to propel growth of the sexually transmitted disease treatment market. For instance, in 2017, GSK and ViiV Healthcare applied in European Medicines Agency (EMA) and US Food and Drug Administration (FDA), for regulatory affiliation for a single-tablet, two-drug regimen of dolutegravir (by ViiV Healthcare) and rilpivirine (by Janssen) used for treatment of HIV-1 infection. Moreover, other drug candidates in pipeline includes – PrEP, PRO140 with ibalizumab, BMS- 955176, which are expected to be launched in the forecast period. Moreover, governments are focusing on funding research and development programs, which is expected to aid in growth of the market. For instance, British Columbia Center for Disease Control sponsored doxycycline (drug) studies for indication of syphilis and other sexually transmitted infection, which is in early phase I clinical trial as of 2016.

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Moreover, increasing governmental initiatives to spread awareness through organization of campaigns and free diagnostic camps is also expected to augment growth of the STDs treatment market. For instance, Centers for Disease Control and Prevention (CDC) launched Improving Sexually Transmitted Disease Programs through Assessment, Assurance, Policy Development, and Prevention Strategies, or STD-AAPPS, in 2014. Moreover, in 2018, Thunder Bay Group—HIV / AIDS / hepatitis C education and support services provider— expanded the access of hepatitis C medicine for individuals with level 2 hepatitis C, after negotiating with the provinces and drug manufacturers.

However, growth of the sexually transmitted disease treatment market is expected to be restrained by low rate of screening for diseases and late diagnosis of the disease such as HIV.  

Sexually Transmitted Diseases Treatment market – Competitor

Major players in highly fragmented sexually transmitted diseases treatment market are Merck & Co. Inc., Pfizer INC, GlaxoSmithKline Plc, Vertex Pharmaceuticals, Roche, Gilead Sciences Inc., AbbVie Inc., Johnson & Johnson and Bristol-Myers Squibb. Key players in sexually transmitted disease treatment market are focusing on adopting strategies such as mergers and collaborations for expanding their research for candidate drugs. For instance, in 2017, the drug Zoloflodacin entered into clinical trials, as a result of partnership between Global Antibiotic Research and Development Partnership (GARDP) and Entasis Therapeutics. Moreover, in March 2018, Inovio Pharmaceuticals, Inc. entered into a deal with ApolloBio Corp., which have the exclusive rights for development, manufacturing, and commercialization of VGX – 3100, Inovio’s DNA immunotherapy product for pre-cancer indication.

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Infectious Disease Drug Market 2021 future outlook of statistics on industry growth

Market Analysis and Insights: Infectious Disease Drug Market

Infectious Disease Drug Market By Source Type (Bacterial Diseases, Virusal Diseases, Fungal Disease and Parasitic Disease), By Disease Type (Jaundice, Leprosy, Listeria, Lyme disease, Malaria, Measles, Molluscum contagiosum, Molluscum contagiosum, Norovirus, Pyelonephritis, Rabies, Severe acute respiratory syndrome, Sepsis, Tetanus, West Nile, Zika, Ebola disease and Others) By Treatment Type (Medication, Dietary supplements and surgery), By Mode of Action Type (Antibacterial drugs, Antiviral drugs, Antifungal drugs, Antiparasitic drugs ), By Drug Type (Tafenoquine, Omadacycline, Tecovirimat, Eravacycline, Delafloxacin, Plazomicin, Benznidazole, Secnidazole, Daclatasvir, Dalbavancin and Others), By Route of Administration (Oral, Topical and intravenous), By End- users (Hospitals, Homecare, Specialty Clinics, Others), By Geography (North America, South America, Europe, Asia-Pacific, Middle East and Africa)  - Industry Trends & Forecast to 2026

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Global infectious disease drugs market is rise gradually to an estimated value of USD 72.49 Billion by 2026 registering a CAGR of 5.5% in the forecast period of 2019-2026 with the annual sales of USD 47.24 billion in the year 2018. This significant rise in market value can increases research development initiatives to launching novel therapies.

Market Definition: Global Infectious Disease Drug Market

Infectious disease is defined as pathogenic microorganism disease caused by infectious agent such as bacteria, viruses, fungi and parasites. It can spread from one person to another healthy individual. People who have likely to developed weakened immune system, this could be due to drugs, age, or other diseases and people who they have not been vaccinated before are prone to the infections.

According to the article published in our World in Data 2016, the global burden of infectious disease was responsible for 10.0 % of causes of death in the world. It is identified that over 229.96 million patients affected with diarrhea and infectious disease. Increases of cases of prevalence rate, Advances in nutrition, antibiotics and immunization. Accelerate demanding of novel therapies and newer developments in diagnostic devices and Government initiatives in sanitization and regulations for food safety are the drivers for market growth.

Market Drivers

Increases of cases of prevalence rate of     infectious diseases worldwide

Advances in nutrition, antibiotics and     immunization

Accelerate demanding of novel therapies     and newer development in diagnostic devices

Rising awareness about treatment and     technological advancement is driving the growth of market

Prevalence of indoor as well as outdoor     infections

Government initiatives programs in     sanitization and regulations for food safety

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Market Restraints

Effective treatment is either     unavailable or unaffordable.

Patent expiry from many companies and     introduction of generic drugs is expected to restrain the growth if the     market.

Lack of awareness among the patient and     physician about asthma disease treatment.

Segmentation: Global Infectious Disease Drug Market

By Source Type

Bacterial Diseases

Viruses Diseases

Fungus Disease

Parasites Disease

By Disease Type

Jaundice

Leprosy

Listeria

Lyme disease

Malaria

Measles

Molluscum contagiosum

Norovirus

Pyelonephritis

Rabies

Severe acute respiratory syndrome

Sepsis

Tetanus

West Nile

Zika

Ebola disease

Others

By Treatment

Medication

Dietary supplements

Surgery

By Route of administration

Oral

Topical

Injectable

 By End users

Hospitals

Homecare

Specialty Clinics

Others

By Geography

 U.S.

 Canada

 Mexico

 Brazil

 Argentina

 Rest of South America

 Germany

 France

 United Kingdom

 Italy

 Spain

 Russia

 Turkey

 Belgium

 Netherlands

 Switzerland

 Rest of Europe

 Japan

 China

 South Korea

 India

 Australia

 Singapore

 Thailand

 Malaysia

 Indonesia

 Philippines

 Rest of Asia Pacific

 South Africa

 Egypt

 Saudi Arabia

 United Arab Emirates

 Israel

 Rest of Middle East & Africa

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Key Developments in the Market:

On 01 May 2019, Sanofi S.A received FDA approval for Dengvaxia (Dengue Tetravalent Vaccine, Live) for the prophylaxes of dengue disease caused by dengue virus serotypes (1, 2, 3 and 4) in patient upto 9 years old. Dengvaxia also received European Commission approval for treatment of Dengue fever in European endemic areas.

On 8 April 2019, ViiV Healthcare group of companies received FDA approval for Dovato (dolutegravir and lamivudine), a fixed dose combination for the treatment of HIV-infected adults patients who have never treated by any antiretroviral drugs.

0n 13 Feb 2019, Novartis AG received the FDA approval for Egaten (triclabendazole) for the treatment of liver flukes specifically caused by fascioliasis and paragonimiasis. WHO recognized Egaten in an essential medicines lists.

Competitive Analysis:

Global  Infectious Disease Drug Market is highly fragmented and the major players have used various strategies such as new product launches, expansions, agreements, joint ventures, partnerships, acquisitions, and others to increase their footprints in this market. The report includes market shares of Infectious Disease market for global, Europe, North America, Asia-Pacific, South America and Middle East & Africa.

Key Market Players:

Few of the major competitors currently working in the Infectious Disease market are F. Hoffmann-La Roche Ltd (Switzerland), Gilead Sciences, Inc. (US), GlaxoSmithKline Plc (UK), Johnson & Johnson Services, Inc. (US), Merck & Co., Inc. (US), Pfizer Inc. (US), AbbVie Inc. (US), Vertex Pharmaceuticals Incorporated (US), ViiV Healthcare group of companies (UK), Sanofi S.A (France), Eli Lilly and Company (US) , Novartis AG (Switzerland), Mitsubishi Tanabe Pharma Corporation (Japan) and few among others.

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[amshrihari]

SMALL MOLECULE ANTI-INFECTIVE DRUG MARKET ANALYSIS

Small Molecule Anti-infective Drug Market, by Product Type (Antibiotics (B Lactam, Quinolones, Macrolides, Tetracyclines, Aminoglycosides, Sulphonamides, and Others), Antifungal ( Azoles, Echinocandins, Polyenes, and Others), Antivirals (Nucleoside Reverse Transcriptase Inhibitors, Non-nucleoside Reverse Transcriptase Inhibitors, and Others), and Others (Anthelminthic and Antiprotozoal), by Indication (Pneumonia, MRSA Infections, MSSA Infections, Sinusitis, Tuberculosis, Dermatophytosis, Aspergillosis, Candidiasis, Hepatitis, HIV Infection, Respiratory Tract Infection, Urinary Tract Infection, and Others), by Distribution Channels (Hospital Pharmacies, Retail Pharmacies, and Online Pharmacies), and by Region (North America, Europe, Asia Pacific, Latin America, Middle East, and Africa) - Global Industry Insights, Trends, Outlook, and Opportunity Analysis, 2019 – 2026

Source https://www.coherentmarketinsights.com/ongoing-insight/small-molecule-anti-infective-drug-market-2655  

Small molecule anti-infective drugs are used for the treatment of various infectious diseases such as Methicillin-resistant Staphylococcus aureus (MRSA) infections, Methicillin-Susceptible Staphylococcus aureus (MSSA) infections, sinusitis, cellulitis, pneumonia, tuberculosis, aspergilosis, and hepatitis. Anti-infective drugs have the capability to eliminate and suppress infections that are caused by various bacteria and viruses.

Small Molecule Anti-infective Drug Market Drivers

Increasing approval of new drugs is expected to drive growth of the global small molecule anti-infective drug market. For instance, in April 2019, the U.S. Food and Drug Administration (FDA) announced the approval of Dovato (dolutegravir and lamivudine), which is used for the treatment of HIV-1 infection in adults. It is manufactured by ViiV Healthcare.

Furthermore, in August 2018, Tetraphase Pharmaceuticals received the U.S. Food and Drug Administration approval for its new drug, Xerava containing Eravacycline, which is used for the treatment of complicated intra-abdominal infections (CIAI).

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Small Molecule Anti-infective Drug Market Restraints

Increasing severe side effect of drugs is the major restraining factor of anti-infective drug market, it is expected to the hamper the small molecule anti-infective drug market growth. For instance, NBC news report in December 2018, U.S Food and drug administration sends warning letters to Fluroquinonolone antibiotics because U.S FDA found that Fluroquinolones antibiotic can increase the occurrence of serious events of rupture in the main artery of the body. These ruptures called as the aortic dissections.

Small Molecule Anti-infective Drug Market Regional Analysis

On the basis of region, the global small molecule anti-infective drug market is segmented into North America, Latin America, Europe, Asia Pacific, Middle East, and Africa.

North America is expected to hold dominant position in the small molecule anti-infective drugs market, owing to new product launches of small molecule anti-infective drugs. For instance, in November 2018, Xellia Pharmaceuticals launched its new product, Vancomycine Hydrochloride for injection, in the U.S market.

Furthermore, Asia Pacific is also projected to witness significant growth in the global small molecule anti-infective drugs market, owing to increasing collaboration activities among key players. For instance, in April 2018, Entasis Therapeutics Holdings Inc. collaborated with the Zai Lab Limited. This collaboration facilitated phase III clinical trial for a fixed-dose combination of ETX2514 and sulbactam. This combination is intended for the treatment of multidrug-resistant infections caused by Acinetobacter baumannii bacteria. The study started in April 2019 and is expected to complete in July 2020.

Key players operating in the global small molecule anti-infective market include, Merck & Co., Inc., AstraZeneca, Theravance Biopharma, Bristol-Myers Squibb Company, Novartis AG, Bayer AG, Pfizer, Inc., Sanofi, GlaxoSmithKline plc. (GSK),and Allergan plc.

Small Molecule Anti-infective Drug Market Taxonomy

By Product Type

Antibiotics

Antifungal Drugs

Antiviral Drugs

Others

B Lactam

Quinolones

Macrolides

Tetracyclines

Aminoglycosides

Sulphonamide

Others

Azoles

Echinocandins

Polyenes

Others

Nucleoside Reverse Transcriptase Inhibitors,

Non-nucleoside Reverse Transcriptase Inhibitor

Others

Anthelminthic

Antiprotozoal

By Indication

Pneumonia

MRSA Infections

MSSA Infections

Sinusitis

Tuberculosis

Dermatophytosis

Aspergillosis

Candidiasis

Hepatitis

HIV Infection

Respiratory Tract Infection

Urinary Tract Infection

Others

By Distribution Channels

Hospital Pharmacies

Retail Pharmacies

Online Pharmacies

By Region

North America

Europe

Asia Pacific

Latin America

Middle East

Africa

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[pharmaphorumuk]

ViiV gets FDA nod for Rukobia drug for older HIV patients

The FDA has approved Rukobia, a first-in-class drug from ViiV Healthcare intended for older people with HIV, who have been on antiretroviral therapy (ART) for so long it is starting to fail.

When the HIV epidemic started more than 30 years ago, patients could only expect to live for one to two years from diagnosis but the introduction of increasingly effective combination ART regimens has since restored the life expectancy of people with HIV to near normal levels.

The trouble is, there is an increasing population of people with HIV who have been on ART for so long that it is starting to lose its efficacy. In fact, more than a third (36%) of the US HIV-positive population – some 400,000 people – were aged over 55 in 2018.

HIV specialist ViiV – which is majority-owned by GlaxoSmithKline – has claimed approval from the US regulator for Rukobia (fostemsavir) as a rescue therapy for heavily pre-treated adults in whom the virus has developed resistance to multiple ARTs.

The clearance is based on the phase 3 BRIGHTE study, which showed that fostemsavir was significantly better than placebo when added on to current therapy at reducing viral load in this hard-to-treat patient population. 

Rukobia is the lead drug in a new class of HIV attachment inhibitors, which bind to a glycoprotein (gp120) on the envelope of HIV and prevent the virus binding to host cells. Its mechanism of action means there is no cross-resistance to other classes of anti-retroviral drugs, according to ViiV.

The drugmaker estimates that around 6% of all adults with HIV in the US have been heavily pre-treated and so are at greater risk of progressing to AIDS.

That’s a relatively small but growing group of patients, and analysts have predicted that sales of Rukobia will be modest at around $400 million, much smaller than ViiV’s other new products – like Juluca (dolutegravir/rilpivirine) and Dovato (dolutegravir/lamivudine) – which some analysts think could garner $1 billion-plus revenues.

Nevertheless, it’s another addition to ViiV’s product range as it tries to wrest market share from Gilead Sciences, its arch-rival in the HIV market.

Gilead has been growing at a phenomenal rate thanks to new drugs like triple therapy Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide). Meanwhile, ViiV has been trying to convince doctors that its two-drug regimens are safer and more cost-effective, although at the moment Gilead seems to be in the ascendency.

Sales of Biktarvy more than doubled in the first quarter of this year to $1.7 billion, while during the same period Juluca grew 71% to $150 million and Dovato added another $82 million.

ViiV suffered a setback in its HIV franchise at the end of 2019 however when the FDA rejected its once-monthly injectable Cabenuva (cabotegravir/rilpivirine), after finding fault with manufacturing data for the drug. Fostemsavir has also been submitted for approval in other markets, including Europe.

The post ViiV gets FDA nod for Rukobia drug for older HIV patients appeared first on .

from https://pharmaphorum.com/news/viiv-gets-fda-nod-for-rukobia-drug-for-older-hiv-patients/

[bigyack-com]

New Strawberry-Flavored H.I.V. Drugs for Babies Are Offered at $1 a Day

About 80,000 babies and toddlers die of AIDS each year, mostly in Africa, in part because their medicines come in hard pills or bitter syrups that are very difficult for small children to swallow or keep down.But on Friday, the Indian generic drug manufacturer Cipla announced a new, more palatable pediatric formulation. The new drug, called Quadrimune, comes in strawberry-flavored granules the size of grains of sugar that can be mixed with milk or sprinkled on baby cereal. Experts said it could save the lives of thousands of children each year.“This is excellent news for all children living with H.I.V.,” said Winnie Byanyima, the new executive director of UNAIDS, the United Nations agency in charge of the fight against the disease. “We have been eagerly waiting for child-friendly medicines that are easy to use and good to taste.”Cipla revolutionized the provision of AIDS drugs for adults almost two decades ago, pricing them at $1 a day. The new pediatric formulation will likewise be priced at $1 a day. The announcement by Cipla and the Drugs for Neglected Diseases Initiative, an offshoot of Doctors Without Borders that supported the development of the drug, was timed to coincide with World AIDS Day, which is Sunday.Despite big advances in the prevention of mother-child transmission of H.I.V., about 160,000 children are still born infected each year, according to UNAIDS, mostly in the poorest towns and villages of Africa. Almost half of them die before the age of 2, usually because they have no access to drugs or cannot tolerate them.Quadrimune is still under review by the Food and Drug Administration, and F.D.A. approval almost inevitably leads to rapid certification by the World Health Organization. The company hopes to get a decision by May. Trials in healthy adults showed that the new formulation gets the drugs into the blood; the four drugs in it were approved in the 1990s and are used in many combinations.A clinical trial in H.I.V.-infected infants, run by Epicentre, the research arm of Doctors Without Borders, is now underway in Uganda to prove to African health ministries that children accept the new formulation. Most of the research costs have been paid by UNITAID, a Geneva-based organization set up by​ France, Norway, Brazil and some other countries ​which imposed special taxes on airline flights that are dedicated to ​bettering​ global health. Currently, the most common pediatric drug combination includes a syrup that is 40 percent alcohol, has a bitter metallic taste that lingers for hours and must be transported in cold trucks and then kept in a refrigerator — something that many poor rural families do not own.“Some families try to bury it in wet sand or dirt to keep it cool,” said Dr. Bernard Pécoul, executive director of the neglected diseases initiative. “And the children are vomiting it on a regular basis.” Moreover, each drug must be squirted into a child’s mouth with a separate syringe, so a mother must have up to four syringes on hand and clean them for each subsequent use. Children generally have to take the medicines twice a day for the first four years of life. When liquid versions are unavailable, some pills cannot be crushed and mixed in juice; they must be swallowed whole. In contrast, Quadrimune contains four H.I.V. drugs: ritonavir, lopinavir, abacavir and lamivudine. The granules are coated first in a polymer that doesn’t melt until it reaches the stomach, and then with sweet, fruity flavoring. Dr. Kogie Naidoo, who heads treatment research at Caprisa, an AIDS treatment and research group based in Durban, South Africa, who was not involved in Quadrimune’s development, said the new formulation could solve many problems she and her colleagues encounter while treating children. Cipla, founded in 1935, was the first generic drug company to offer H.I.V. drugs in Africa. In 2001, its chairman, Yusuf K. Hamied, upended the global pharmaceutical industry by offering to supply a three-drug cocktail to Doctors Without Borders for $1 a day. At the time, multinational drug companies were charging up to $15,000 for their regimens and refusing to lower prices except in secret negotiations with a few countries and were working to block generic competitors from the market. An estimated 25 million Africans were then infected and thousands were dying every day. (The industry was also suing South Africa’s president, Nelson Mandela, over a law he had signed authorizing the government to cancel drug patents and award them to generic makers.)In 2001, Dr. Hamied said he was losing money at the $350 a year price; his break-even point was $600, he said, and he offered it to other buyers for that.But he said he acceded to requests from AIDS activists for the $1 a day price to deliver a shock to his Western competitors and because such a nice round figure was likely to make headlines (a gambit he is clearly repeating now).In the decades since, increased generic competition has driven the price of triple therapy in poor countries to below $100 a year.“Over the past 20 years, Cipla has pioneered fixed-dose combinations for children and I do believe our Quadrimune could be a winner,” Dr. Hamied said in an interview this week. Because all four drugs in the formulation are older and no longer patented, Cipla might eventually offer it in wealthy countries too, he said. But that market is quite small because most pregnant women in the West are tested for H.I.V. and immediately put on antiretroviral drugs, which reduces to near zero the chances that they will infect their babies in the womb, during birth or through breastfeeding.The $1 a day price is for Quadrimune doses appropriate for children of between 20 and 30 pounds, he noted, so the cost for newborns would be even lower.Paradoxically, treating infants with H.I.V. has actually become harder in recent years than it was two decades ago.In the early 2000s, Cipla produced Triomune Baby and Triomune Junior, two pediatric formulations of the world’s first adult three-in-one pill, introduced in 2001. But they contained nevirapine, a drug that in those days was often given to pregnant women to prevent mother-child transmission. As a result, many babies were born with nevirapine-resistant forms of the virus, and the efficacy of pediatric Triomune fell by about half, Dr. Pécoul said.Some nevirapine substitutes that work in adults do not work well in children, and the combination that does work has the bitter taste.Nowadays, many pediatric H.I.V. specialists are frustrated that they cannot prescribe some of the newest drugs, such as tenofovir and dolutegravir, because there is little or no data on how safe they are in small children. The major drugmakers have little incentive to test their products in children because there are so few customers who can pay high prices.If a child’s virus develops resistance to any regimen, a new one must be tried, so more research is needed, said Dr. Naidoo, the AIDS researcher in Durban.But by any measure, she said, Cipla’s new, gentler formulation for children is a major advance: “This is indeed great news for treating pediatric H.I.V.” Source link Read the full article

[sapanas]

Active Pharmaceutical Ingredients (API) Market 2020: Global Opportunities, Development Status, Regional Trends, Sales Revenue And Industry Growth With 4.96% Of CAGR By Forecast 2023

Active Pharmaceutical Ingredients (API) Market 2020 Industry Research Report – Global Forecast to 2023, is latest research report on Global Active Pharmaceutical Ingredients Industry published by Market Research Future.

Active Pharmaceutical Ingredients Market Overview:

Market Research Future (MRFR) in their recent report on the active pharmaceutical ingredients market discussed a possibility of attaining 4.93% ACGR during the forecast period (2018-2023). The active pharmaceutical ingredients market can expect to exceed a market valuation of USD 215 billion by the end of 2023. Active pharmaceutical ingredient is the parts of drugs that delivers the impact. In some cases, there are several active pharmaceutical ingredients in a drug as they are a part of combination therapies and aim at reducing several symptoms simultaneously. Drugs basically contain two distinct parts; active pharmaceutical ingredients and excipients. Excipients generally help in delivering the medicine to the system.

Read more news on: https://www.globenewswire.com/news-release/2019/05/16/1826291/0/en/Active-Pharmaceutical-Ingredients-API-Market-Slated-to-Bring-in-USD-215-12-Bn-during-the-forecast-period-2018-to-2023-at-a-CAGR-of-4-93-Says-MRFR.html

The global active pharmaceutical ingredients market is depending much on the quality control as poorly handled one can disastrously affect patient. Strict regulations are to be followed by manufacturers which can be a bit daunting and prohibit the market from growing with the expected CAGR during the forecast period. However, the active pharmaceutical ingredients market can stay clear out of such long-time sluggishness as its ability to reduce production cost is a major traction for the drug manufacturers.

Active Pharmaceutical Ingredients Market Segmentation:

MRFR, for a better understanding of the global active pharmaceutical ingredients market, segmented it by manufacturing process, API formulation, application, type of synthesis, and molecule.

Based on the type of synthesis, the active pharmaceutical ingredients market can be segmented into biotech and synthetic segments. As per the reports of 2017, the synthetic segment was worth of USD 132,690.7 million.

Based on the manufacturing process, the active pharmaceutical ingredients market comprises contract manufacturing and captive manufacturing. The captive manufacturing segment is commanding significant market share and can remain lucrative during the forecast period.

Based on the API formulation, the active pharmaceutical ingredients (API) market can be segmented into innovative API and generic API. The generic API segment, as of 2017, was spearheading the global market.

Molecule-based segmentation of the active pharmaceutical ingredients market reveals small molecule and large molecule. The small molecule segment is generating the maximum revenue and can retain its market superiority during the forecast period.

Based on the application, the active pharmaceutical ingredients market can be segmented into orthopedic disorders, oncology, cardiovascular disease, respiratory, neurological disorders, urology, gastrointestinal disorders and others. The oncology segment is forecasted to witness a substantial growth.

Active Pharmaceutical Ingredients Market Regional Segmentation:

MRFR, in a region-specific discussion of the active pharmaceutical ingredients, includes Europe, Americas, Asia Pacific (APAC), and the Middle East & Africa (MEA). The discussion reveals both volume-wise and value-wise analysis of the market.

The Americas has the maximum market share owing to their rising investment in research and development sector. The region has superlative infrastructure for both the healthcare sector and R & D segment. In addition, high investment from both public and private funds are triggering further developments. The U.S. marks exceptionally well-structured ventures and is dominating the market. The pharmaceutical sector in the region is bearing all the traits of being cutting-edge and is far advanced than its peers.

Europe and the APAC region can also anticipate growth for the active pharmaceutical ingredients (API) market during the forecast period. These two regions have several growth pockets depending on which they can prosper. Europe’s market is the second biggest but the APAC market can project high CAGR as it is now pulling in business from other regions by providing the opportunity of outsourcing. Outsourcing brings down production cost substantially which has lured in a number of market titans into the region to set up facilities in the region.

Obtain Premium Research Report Details, Considering the impact of COVID-19 @ https://www.marketresearchfuture.com/reports/active-pharmaceutical-ingredients-market-1385

Active Pharmaceutical Ingredients Market Competitive Landscape:

Major active pharmaceutical ingredients market influencers, as per the MRFR report, are Eli Lilly and Company, Pfizer Inc., Novartis AG, Bayer AG, Boehringer Ingelheim GmbH, Abbott Laboratories, GlaxoSmithKline Plc (GSK), F. Hoffmann-La Roche AG, Sanofi, Merck & Co., Inc., and Teva Pharmaceutical Industries Ltd.

In February 2019, Raltegravir (potassium) (WHOAPI-326) of Mylan Laboratories Ltd and dolutegravir (sodium) (WHOAPI-325) from Laurus Labs Ltd passed the prequalification level. The test was conducted by WHO Prequalification Team following their API prequalification procedure.

[nasiknews]

Dolutegravir Market 2020 by Manufacturers, Regions, Type, Application and Regions (North America, Europe and Asia-Pacific, South America, Middle East and Africa)

Dolutegravir Market 2020 by Manufacturers, Regions, Type, Application and Regions (North America, Europe and Asia-Pacific, South America, Middle East and Africa)

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The MarketWatch News Department was not involved in the creation of this content.

May 10, 2020 (The Expresswire) — Global “Dolutegravir Market” report provides valuable information regarding new products in the market, current scenario, and key players operating the industry. It provides growth and development status of Dolutegravir industry with top regions, types, and…

[jesse-pinkman123]

Small Molecule Anti-infective Drug Market Forecast Opportunity Analysis-2027

Small Molecule Anti-infective Drug Market, by Product Type (Antibiotics (B Lactam, Quinolones, Macrolides, Tetracyclines, Aminoglycosides, Sulphonamides, and Others), Antifungal ( Azoles, Echinocandins, Polyenes, and Others), Antivirals (Nucleoside Reverse Transcriptase Inhibitors, Non-nucleoside Reverse Transcriptase Inhibitors, and Others), and Others (Anthelminthic and Antiprotozoal), by Indication (Pneumonia, MRSA Infections, MSSA Infections, Sinusitis, Tuberculosis, Dermatophytosis, Aspergillosis, Candidiasis, Hepatitis, HIV Infection, Respiratory Tract Infection, Urinary Tract Infection, and Others), by Distribution Channels (Hospital Pharmacies, Retail Pharmacies, and Online Pharmacies), and by Region (North America, Europe, Asia Pacific, Latin America, Middle East, and Africa) - Global Industry Insights, Trends, Outlook, and Opportunity Analysis, 2019 – 2026

Small molecule anti-infective drugs are used for the treatment of various infectious diseases such as Methicillin-resistant Staphylococcus aureus (MRSA) infections, Methicillin-Susceptible Staphylococcus aureus (MSSA) infections, sinusitis, cellulitis, pneumonia, tuberculosis, aspergilosis, and hepatitis. Anti-infective drugs have the capability to eliminate and suppress infections that are caused by various bacteria and viruses.

* The sample copy includes: Report Summary, Table of Contents, Segmentation, Competitive Landscape, Report Structure, Methodology.

Request a sample copy of this report: https://www.coherentmarketinsights.com/insight/request-sample/2655

Small Molecule Anti-infective Drug Market Drivers

Increasing approval of new drugs is expected to drive growth of the global small molecule anti-infective drug market. For instance, in April 2019, the U.S. Food and Drug Administration (FDA) announced the approval of Dovato (dolutegravir and lamivudine), which is used for the treatment of HIV-1 infection in adults. It is manufactured by ViiV Healthcare.

Furthermore, in August 2018, Tetraphase Pharmaceuticals received the U.S. Food and Drug Administration approval for its new drug, Xerava containing Eravacycline, which is used for the treatment of complicated intra-abdominal infections (CIAI).

Small Molecule Anti-infective Drug Market Restraints

Increasing severe side effect of drugs is the major restraining factor of anti-infective drug market, it is expected to the hamper the small molecule anti-infective drug market growth. For instance, NBC news report in December 2018, U.S Food and drug administration sends warning letters to Fluroquinonolone antibiotics because U.S FDA found that Fluroquinolones antibiotic can increase the occurrence of serious events of rupture in the main artery of the body. These ruptures called as the aortic dissections.

Small Molecule Anti-infective Drug Market Regional Analysis

On the basis of region, the global small molecule anti-infective drug market is segmented into North America, Latin America, Europe, Asia Pacific, Middle East, and Africa.

Browse Research Report: https://www.coherentmarketinsights.com/ongoing-insight/small-molecule-anti-infective-drug-market-2655

North America is expected to hold dominant position in the small molecule anti-infective drugs market, owing to new product launches of small molecule anti-infective drugs. For instance, in November 2018, Xellia Pharmaceuticals launched its new product, Vancomycine Hydrochloride for injection, in the U.S market.

Furthermore, Asia Pacific is also projected to witness significant growth in the global small molecule anti-infective drugs market, owing to increasing collaboration activities among key players. For instance, in April 2018, Entasis Therapeutics Holdings Inc. collaborated with the Zai Lab Limited. This collaboration facilitated phase III clinical trial for a fixed-dose combination of ETX2514 and sulbactam. This combination is intended for the treatment of multidrug-resistant infections caused by Acinetobacter baumannii bacteria. The study started in April 2019 and is expected to complete in July 2020.

Key players operating in the global small molecule anti-infective market include, Merck & Co., Inc., AstraZeneca, Theravance Biopharma, Bristol-Myers Squibb Company, Novartis AG, Bayer AG, Pfizer, Inc., Sanofi, GlaxoSmithKline plc. (GSK),and Allergan plc.

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[azveille]

GSK's ViiV seeks marketing license for baby-friendly HIV pill

British drugmaker GSK applied on Friday for a license to market its HIV drug dolutegravir in a formulation designed to be easier for babies and children who are living with the virus to swallow. 

About 1.7 million children have HIV, most of them in sub-Saharan Africa, the United Nations agency UNAIDS says.

If approved by regulators, the medicine will be the first new generation HIV medicine available in baby-friendly form.

Doctors wanting to use dolutegravir in children with HIV have had no licensed child formulations, meaning they often have to prescribe older HIV medicines that can be less potent, harder for children to take, and have more side effects.

“Children in today’s world, still have fewer options in terms of HIV therapies compared to adults,” said Harmony Garges, chief medical officer for ViiV Healthcare, GSK’s HIV drugs division. She said she hoped the license application would “enable approval of dolutegravir across the pediatric spectrum”.

ViiV’s CEO Deborah Waterhouse added in a statement: “For parents living in resource-poor countries, the ability to give medicine to children in a format that they can swallow and tolerate can mean the difference between life and death.”

Dolutegravir is a so-called integrase inhibitor and was originally developed by ViiV, in which Pfizer Inc and Shionogi & Co have small stakes. For the adult formulation, ViiV has already agreed licensing deals with generic companies to sell low-cost versions in poor countries.

New HIV infections among children have fallen by 41% since 2010, but there were 160,000 new cases in babies and children in 2018, and 100,000 children died of AIDS last year, partly due to lack of access to HIV medicines.

Helen McDowell, ViiV’s head of government affairs and global public health, said that subject to licenses being granted by U.S. and European drug regulators, the company was planning for an initial roll-out in sub-Saharan Africa next year.

ViiV’s version of the child formulation will be priced at “cost of production” she said but declined to give more detail.

ViiV is planning licensing agreements with two generic drugmakers, Mylan Laboratories and Macleods Pharmaceuticals, who aim to make cheaper generic versions of the dispersible pill available within months of ViiV’s coming to market, she added.

Indian generic drugmaker Cipla said last month it was seeking regulatory approval for a four-in-one HIV drug combination called Quadimmune, which it promised to price at below $1 a day.

[biofunmy]

New Strawberry-Flavored H.I.V. Drugs for Babies Are Offered at $1 a Day

About 80,000 babies and toddlers die of AIDS each year, mostly in Africa, in part because their medicines come in hard pills or bitter syrups that are very difficult for small children to swallow or keep down.

But on Friday, the Indian generic drug manufacturer Cipla announced a new, more palatable pediatric formulation. The new drug, called Quadrimune, comes in strawberry-flavored granules the size of grains of sugar that can be mixed with milk or sprinkled on baby cereal. Experts said it could save the lives of thousands of children each year.

“This is excellent news for all children living with H.I.V.,” said Winnie Byanyima, the new executive director of UNAIDS, the United Nations agency in charge of the fight against the disease. “We have been eagerly waiting for child-friendly medicines that are easy to use and good to taste.”

Cipla revolutionized the provision of AIDS drugs for adults almost two decades ago, pricing them at $1 a day. The new pediatric formulation will likewise be priced at $1 a day. The announcement by Cipla and the Drugs for Neglected Diseases Initiative, an offshoot of Doctors Without Borders that supported the development of the drug, was timed to coincide with World AIDS Day, which is Sunday.

Despite big advances in the prevention of mother-child transmission of H.I.V., about 160,000 children are still born infected each year, according to UNAIDS, mostly in the poorest towns and villages of Africa. Almost half of them die before the age of 2, usually because they have no access to drugs or cannot tolerate them.

Quadrimune is still under review by the Food and Drug Administration, and F.D.A. approval almost inevitably leads to rapid certification by the World Health Organization. The company hopes to get a decision by May.

Trials in healthy adults showed that the new formulation gets the drugs into the blood; the four drugs in it were approved in the 1990s and are used in many combinations.

A clinical trial in H.I.V.-infected infants, run by Epicentre, the research arm of Doctors Without Borders, is now underway in Uganda to prove to African health ministries that children accept the new formulation. Most of the research costs have been paid by UNITAID, a Geneva-based organization set up by​ France, Norway, Brazil and some other countries ​which imposed special taxes on airline flights that are dedicated to ​bettering​ global health.

Currently, the most common pediatric drug combination includes a syrup that is 40 percent alcohol, has a bitter metallic taste that lingers for hours and must be transported in cold trucks and then kept in a refrigerator — something that many poor rural families do not own.

“Some families try to bury it in wet sand or dirt to keep it cool,” said Dr. Bernard Pécoul, executive director of the neglected diseases initiative. “And the children are vomiting it on a regular basis.”

Moreover, each drug must be squirted into a child’s mouth with a separate syringe, so a mother must have up to four syringes on hand and clean them for each subsequent use. Children generally have to take the medicines twice a day for the first four years of life. When liquid versions are unavailable, some pills cannot be crushed and mixed in juice; they must be swallowed whole.

In contrast, Quadrimune contains four H.I.V. drugs: ritonavir, lopinavir, abacavir and lamivudine. The granules are coated first in a polymer that doesn’t melt until it reaches the stomach, and then with sweet, fruity flavoring.

Dr. Kogie Naidoo, who heads treatment research at Caprisa, an AIDS treatment and research group based in Durban, South Africa, who was not involved in Quadrimune’s development, said the new formulation could solve many problems she and her colleagues encounter while treating children.

Cipla, founded in 1935, was the first generic drug company to offer H.I.V. drugs in Africa. In 2001, its chairman, Yusuf K. Hamied, upended the global pharmaceutical industry by offering to supply a three-drug cocktail to Doctors Without Borders for $1 a day.

At the time, multinational drug companies were charging up to $15,000 for their regimens and refusing to lower prices except in secret negotiations with a few countries and were working to block generic competitors from the market. An estimated 25 million Africans were then infected and thousands were dying every day. (The industry was also suing South Africa’s president, Nelson Mandela, over a law he had signed authorizing the government to cancel drug patents and award them to generic makers.)

In 2001, Dr. Hamied said he was losing money at the $350 a year price; his break-even point was $600, he said, and he offered it to other buyers for that.

But he said he acceded to requests from AIDS activists for the $1 a day price to deliver a shock to his Western competitors and because such a nice round figure was likely to make headlines (a gambit he is clearly repeating now).

In the decades since, increased generic competition has driven the price of triple therapy in poor countries to below $100 a year.

“Over the past 20 years, Cipla has pioneered fixed-dose combinations for children and I do believe our Quadrimune could be a winner,” Dr. Hamied said in an interview this week.

Because all four drugs in the formulation are older and no longer patented, Cipla might eventually offer it in wealthy countries too, he said. But that market is quite small because most pregnant women in the West are tested for H.I.V. and immediately put on antiretroviral drugs, which reduces to near zero the chances that they will infect their babies in the womb, during birth or through breastfeeding.

The $1 a day price is for Quadrimune doses appropriate for children of between 20 and 30 pounds, he noted, so the cost for newborns would be even lower.

Paradoxically, treating infants with H.I.V. has actually become harder in recent years than it was two decades ago.

In the early 2000s, Cipla produced Triomune Baby and Triomune Junior, two pediatric formulations of the world’s first adult three-in-one pill, introduced in 2001.

But they contained nevirapine, a drug that in those days was often given to pregnant women to prevent mother-child transmission. As a result, many babies were born with nevirapine-resistant forms of the virus, and the efficacy of pediatric Triomune fell by about half, Dr. Pécoul said.

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Some nevirapine substitutes that work in adults do not work well in children, and the combination that does work has the bitter taste.

Nowadays, many pediatric H.I.V. specialists are frustrated that they cannot prescribe some of the newest drugs, such as tenofovir and dolutegravir, because there is little or no data on how safe they are in small children. The major drugmakers have little incentive to test their products in children because there are so few customers who can pay high prices.

If a child’s virus develops resistance to any regimen, a new one must be tried, so more research is needed, said Dr. Naidoo, the AIDS researcher in Durban.

But by any measure, she said, Cipla’s new, gentler formulation for children is a major advance: “This is indeed great news for treating pediatric H.I.V.”

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INSTGRA AND TAFERO EM 12 MONTHS

Drug profile of Instgra Tafero EM 12 months tablets

Instgra Tafero EM tablets are used for treatment involved in HIV-1 infections.

Instgra tablets are containing Dolutegravir as an active component; whereas Tafero EM tablets are containing Tenofovir Alafenamide & Emtricitabine as active ingredients.

Instgra is pharmacologically classified as an integrase inhibitor.

Tafero EM is pharmacologically classified as nucleoside reverse transcriptase inhibitor.

This Instgra Tafero EM combination is approved by FDA, which may provide better activity against HIV-1 infections.

Instgra Tafero EM should not have capability of curing the HIV infection, but it can able to reduce the development of HIV-1 further to AIDS.

This is a fixed dose combination of one Integrase inhibitor with two nucleoside reverse transcriptase inhibitors.

Brand name: Instgra Tafero EM 12 months tablets

Active components: Dolutegravir + Tenofovir Alafenamide & Emtricitabine

Strength: 50mg + 25mg & 200mg respectively

Pack: 30 tablets in a container of both products

Mfg: Instgra – Emcure; Tafero EM - Hetero

Category: Anti-retroviral drugs

Prescribing information of Instgra Tafero EM

The prescribing information of Instgra Tafero EM is used for treating the HIV 1 infection for both adults and pediatric weighing of at least 30kg.

Tafero EM should not be combined with protease inhibitors.

Tafero EM indicated in pediatric patient with weight of at least 25kg & below 35kg.

Drawback occurs in Tafero EM uses;

Tafero EM should not be used in pre exposure prophylaxis therapy to diminish the danger of sexually obtained HIV-1 in grown-ups at high hazard.

Mechanism of Instgra Tafero EM

Instgra- Dolutegravir is a competitive to virus associated to HIV infection.

Dolutegravir is an Integrase strand transferase inhibitor, which is active against HIV type 1 infection. Dolutegravir binds to the active site of integrase enzyme, HIV enzyme that helps to transmit viral genetic material into human chromosomes.

This binding inhibition prevents integrase binding to retro virus DNA and causes blockade of strand transfer step which is required for cell proliferation process.

Instgra helps to prevent the HIV type 1 cell production.

TAF is manufactured as prodrug, which is conversed into active form inside the body known as tenofovir. TAF containing cell permeability activities, through this effect it get penetrate into the infected cells and changed over as tenofovir.

Inside the cells, tenofovir is phosphorylated into tenofovir diphosphate by hydrolysis.

Tenofovir diphosphate shown anti-retroviral activity by intercedes into viral DNA and causes inhibition of chain formation leads to stopping the viral production.

Emtricitabine into Emtricitabine 5’ triphosphate, this conversion occurs inside the body and causes chain eliminator effect by struggling with deoxycytidine 5’triphosphate.

Absorption

After administration, the maximum plasma concentration of Tafero EM;

TAF within 60 minutes; Emtricitabine occurs within 3 hours

Dolutegravir reaches within 2 to 3 hours.

The steady state level of Dolutegravir occurs within 5 days

The blood plasma ratio of Tafero EM;

TAF: 1.0; Emtricitabine: 0.6

Distribution

Binding property of TAF to human plasma protein by 80%; Emtricitabine to <4%

Dolutegravir is broadly binds to proteins by 98.9%.

Metabolism

The metabolism of Dolutegravir is majorly occurs with the aid of UTG1A1 with lesser range of CYP3A

The metabolism of TAF is occurs through cathepsin A, carboxyl esterase 1

Emtricitabine undergoes biotransformation.

Excretion

The major metabolism of Tafero EM is occurs through kidneys.

70% of Emtricitabine dose occurs via urine; 13.7% via feces.

<1% of TAF dose eliminated via urine; 31.7% eliminated via feces.

The elimination route of Dolutegravir is majorly occurs in urine, feces.

The half life period of Instgra is 14 hours

The half life period of Tafero EM is;

TAF: 0.51 hour; Emtricitabine 10 hours

When to take the Instgra Tafero EM

Both Instgra Tafero EM tablets should be administered with or without food.

Before taking the Tafero EM tablet, patient must be examine for hepatitis B infection.

Renal function test should be followed.

Dosage regimens of Instgra Tafero EM

The prescribed dose of Tafero EM is one tablet should be administered as a single dose.

Tafero EM is applicable for adults, pediatric with body weight at least 25 kg or below 35kg, or creatinine clearance higher or equal to 30ml/min.

Tafero EM should not be used in patient with CrCl below 30ml/min.

The dosage of Instgra tablets;

For adults;

Therapy naïve or therapy experienced INSTI:

The dose of Instgra is 50mg should be administered orally as once a day.

Therapy naïve or therapy experienced by combining with UGT1A or CYP3A:

The dose of Instgra is 50mg should be administered orally as two times a day.

Instgra Tafero EM caused side effects

Instgra associated side effects;

Hypersensitivity reactions

Liver toxicity

Immune reconstitution syndrome

Insomnia

Depression

Abnormal dreams

Dizziness

Headache

Diarrhea

Nausea

Rash

Fatigue

Vertigo

Elevation of;

AST, ALT

Bilirubin

Creatine kinase

Blood glucose

Lipase

Post marketing effects;

Acute liver damage, liver toxicity

Arthralgia

Myalgia

Anxiety

Tafero EM associated side effects;

Aggravation of hepatitis B

Immune reconstitution syndrome

Outbreak or severity of renal impairment

Lactic acidosis or hepatic steatosis

Loss of bone mineral density

Laboratory abnormality

Virological response alteration

Drug- drug interaction

1. TAF is a component of Tafero EM which is considered as substrate of P-gp, BCRP, OATP1B1, & OATP1B3.

2. Tafero EM co administered with strong P-gp or BCRP inhibitors leads to cause variation in TAF absorption.

3. Tafero EM co administered with P-gp inducers leads to cause depleting the absorption of TAF concludes as decreasing in plasma concentration of TAF and loss of effectiveness of Tafero EM.

4. Co administration of Tafero EM with drugs that inhibits the P-gp or BCRP leads to cause elevates the absorption & plasma concentration of TAF.

5. Tafero EM is majorly eliminated via kidneys. Tafero EM combined with drugs which affect the kidney functions causes increasing the concentration of component in Tafero EM and causes increasing the risk effects of Tafero EM.

6. Tafero EM with protease inhibitors causes decreasing the effect of concentration of TAF.

Food drug interaction

Minor food drug interaction is occur

Diet should be followed by the patients after getting advice from the physician.

Possible contraindications

Hypersensitivity reactions produces, if patients are contraindicate to the component present in both Instgra & Tafero EM.

Co administration of Instgra & dofetilide or metformin is contraindicated because this combination leads to cause increasing the concentration of dofetilide or metformin. This may concludes as life threatening conditions.

Safety measures

During the treatment with Instgra Tafero EM some life threatening conditions may produce. Some safety precautions should be taken during or after completion of treatment.

1. An anaphylactic reaction occurs like rashes, sometimes organ dysfunction also occurs.

In this condition, patient may provide with general supportive measures and monitoring the liver enzymes level periodically.

In severe condition therapy should be discontinued.

2. Liver toxicity: This condition occurs due to increased serum AST & ALT levels.

Hepatic function test should be performed regularly and maintained the levels of hepatic enzymes.

In severe condition, therapy should be stopped.

3. Exposure of adverse reactions due to drug interactions; some drugs may reduce the plasma concentration of both the products and leads to loss the activity.

Pregnancy and lactation

Pregnancy category of Tafero EM is B; Instgra is B

Instgra Tafero EM uses in pregnancy condition as cautiously. Counsel the patients about the risk benefits before starting the treatment with Instgra Tafero EM.

Breast feeding should not be allowed.

Storage and handling

Instgra container should be stores at 25oC; Tafero EM should be stored below 30oC.

Protect from light

Keep away from moisture & heat

Missed dose

In case of missed dose, patient must be consult with physician and follow the regular dosing schedule.

Over dosage

In case of over dosage of Instgra Tafero EM, patient should be;

Provide with general supportive management

The manifestation of over dosage should be monitored.

Instgra is crucial to remove through dialysis, because it is largely bound to human plasma protein.

Tafero EM should be removed by undergoing hemodialysis.

30% of Emtricitabine dose should be eliminated after 3 hours of hemodialysis.

54% of tenofovir content should be removed over the period of 4 hours of dialysis session.

CONTACT US

PHONE NO:+919940472902

EMAIL: millionhealthpharmaceuticals@gmail.com

WEBSITE: https://pillsbag.com/products/instgra-and-tafero-em-12-months

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Small Molecule Anti-infective Drug Market: Moving Towards a Brighter Future 2019-2022

Small molecule anti-infective drugs are used for the treatment of various infectious diseases such as Methicillin-resistant Staphylococcus aureus (MRSA) infections, Methicillin-Susceptible Staphylococcus aureus (MSSA) infections, sinusitis, cellulitis, pneumonia, tuberculosis, aspergilosis, and hepatitis. Anti-infective drugs have the capability to eliminate and suppress infections that are caused by various bacteria and viruses. Click To Read More On Small Molecule Anti-infective Drug Market.

Small Molecule Anti-infective Drug Market Drivers

Increasing approval of new drugs is expected to drive growth of the global small molecule anti-infective drug market. For instance, in April 2019, the U.S. Food and Drug Administration (FDA) announced the approval of Dovato (dolutegravir and lamivudine), which is used for the treatment of HIV-1 infection in adults. It is manufactured by ViiV Healthcare.

Furthermore, in August 2018, Tetraphase Pharmaceuticals received the U.S. Food and Drug Administration approval for its new drug, Xerava containing Eravacycline, which is used for the treatment of complicated intra-abdominal infections (CIAI).

Small Molecule Anti-infective Drug Market Restraints

Increasing severe side effect of drugs is the major restraining factor of anti-infective drug market, it is expected to the hamper the small molecule anti-infective drug market growth. For instance, NBC news report in December 2018, U.S Food and drug administration sends warning letters to Fluroquinonolone antibiotics because U.S FDA found that Fluroquinolones antibiotic can increase the occurrence of serious events of rupture in the main artery of the body. These ruptures called as the aortic dissections.

Key players operating in the global small molecule anti-infective market include, Merck & Co., Inc., AstraZeneca, Theravance Biopharma, Bristol-Myers Squibb Company, Novartis AG, Bayer AG, Pfizer, Inc., Sanofi, GlaxoSmithKline plc. (GSK),and Allergan plc.

Small Molecule Anti-infective Drug Market Taxonomy

By Product Type

*Antibiotics : B Lactam, Quinolones, Macrolides, Tetracyclines, Aminoglycosides, Sulphonamide, Others, Antifungal Drugs, Azoles, Echinocandins, Polyenes, Others.

*Antiviral Drugs : Nucleoside Reverse Transcriptase Inhibitors, Non-nucleoside Reverse Transcriptase Inhibitor Others

*Others : Anthelminthic Antiprotozoal

By Indication : Pneumonia, MRSA Infections, MSSA Infections, Sinusitis, Tuberculosis, Dermatophytosis, Aspergillosis, Candidiasis, Hepatitis, HIV Infection, Respiratory Tract Infection, Urinary Tract Infection, Others.

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Small Molecule Anti-infective Drug Market Regional Analysis

On the basis of region, the global small molecule anti-infective drug market is segmented into North America, Latin America, Europe, Asia Pacific, Middle East, and Africa.

North America is expected to hold dominant position in the small molecule anti-infective drugs market, owing to new product launches of small molecule anti-infective drugs. For instance, in November 2018, Xellia Pharmaceuticals launched its new product, Vancomycine Hydrochloride for injection, in the U.S market.

Furthermore, Asia Pacific is also projected to witness significant growth in the global small molecule anti-infective drugs market, owing to increasing collaboration activities among key players. For instance, in April 2018, Entasis Therapeutics Holdings Inc. collaborated with the Zai Lab Limited. This collaboration facilitated phase III clinical trial for a fixed-dose combination of ETX2514 and sulbactam. This combination is intended for the treatment of multidrug-resistant infections caused by Acinetobacter baumannii bacteria. The study started in April 2019 and is expected to complete in July 2020.

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