Glenmark Pharmaceuticals Ltd has received tentative approval by the United States Food & Drug Administration (U.S. FDA) for Dabigatran Etexilate Capsules, 75 mg, 110 mg, and 150 mg, the generic version of Pradaxa®1 Capsules, 75 mg, 110 mg, and 150 mg, of Boehringer Ingelheim Pharmaceuticals, Inc.
According to IQVIATM sales data for the 12 month period ending October 2020, the Pradaxa® Capsules, 75 mg, 110 mg, and 150 mg market2 achieved annual sales of approximately $550.9 million*.
Glenmark’s current portfolio consists of 166 products authorized for distribution in the U.S. marketplace and 45 ANDA’s pending approval with the U.S. FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.
Reliance Industries Limited (RIL) today announced that its subsidiary Reliance Retail Ventures Limited (RRVL) has acquired a majority equity stake in Vitalic Health Pvt. Ltd. (“Vitalic”) and its subsidiaries (Collectively known as ‘Netmeds’) for a cash consideration of approximately INR 620 crores. This investment represents ~60% holding in the equity share capital of Vitalic and 100% direct equity ownership of its subsidiaries, viz: Tresara Health Private Limited, Netmeds Market Place Limited and Dadha Pharma Distribution Pvt Limited.
Incorporated in 2015, Vitalic and its subsidiaries are in the business of pharma distribution, sales, and business support services. Its subsidiary also runs an online pharmacy platform – Netmeds – to connect customers to pharmacists and enable door step delivery of medicines, nutritional health and wellness products.
Speaking on this strategic investment, Ms. Isha Ambani, Director, RRVL, said, “This investment is aligned with our commitment to provide digital access for everyone in India. The addition of Netmeds enhances Reliance Retail’s ability to provide good quality and affordable health care products and services, and also broadens its digital commerce proposition to include most daily essential needs of consumers. We are impressed by Netmeds’ journey to build a nationwide digital franchise in such a short time and are confident of accelerating it with our investment and partnership.”
Pradeep Dadha, Founder & CEO, Netmeds, said, “It is indeed a proud moment for “Netmeds” to join Reliance family and work together to make quality healthcare affordable and accessible to every Indian. With the combined strength of the group’s digital, retail and tech platforms, we will strive to create more value for everyone in the ecosystem, while providing a superior Omni Channel experience to consumers.”
The Russian President Vladimir Putin has launched a coronavirus vaccine amid the global race to develop and distribute it. The world’s first vaccine comes even with the final stages of clinical trials to test efficiency and safety still going on.
The announcement came in the wake of the Covid-19 pandemic that has infected more than 20 million people and killed around 0.75 million people all over the world. It has also resulted in crippling world economies.
The Russian vaccine has been developed by the Gamaleya Institute in Moscow. The vaccine uses two strains of adenovirus that is known to cause mild cold in humans. Adenovirus vaccine is under trial in many other countries as well. The strains are genetically modified which can cause infected cells to create proteins from the spike of the coronavirus. This is a similar approach to a vaccine under development by AstraZeneca and Oxford University.
As per reports, Russia has dubbed the newly created vaccine “Sputnik V” after its Soviet satellite. Kirill Dmitriev, who is the head of the Russian Direct Investment Fund, an organization responsible for financing the vaccine project, announced that the Phase 3 trials would start by Wednesday. This means that mass production can be expected from September. He also mentioned that around 20 countries have already pre-ordered more than a billion doses.
Putin thanked everyone who has worked on the vaccine’s development and mentioned that this is a very important step for the world. He also hopes that the country’s research body should start the mass production of the vaccine very soon.
When talking about the vaccine, Putin mentions that it works effectively, helps build strong immunity, and has passed all the needed checks. He also added that one of his two daughters have received a shot of the vaccine and is doing well.
Hetero, one of India’s leading generic pharmaceutical companies, announced today that it has received the manufacturing and marketing approval for the investigational antiviral medicine ‘Remdesivir’ from the Drug Controller General of India (DCGI) for the treatment of Covid-19. Hetero’s generic version of Remdesivir will be marketed under the brand name ‘COVIFOR’ in India.
Dr. B. Partha Saradhi Reddy, Chairman, Hetero Group of Companies, commented: “In the light of increasing COVID-19 cases in India, the approval of ‘COVIFOR’ (Remdesivir) can prove to be a game-changer given its positive clinical outcomes. Backed by strong backward integration capabilities, we can ensure that the product is immediately made available to patients across the country. We are prepared for ensuring enough stocks required to cater to the present needs. We will continue to work closely with the government and medical community to make a difference in the fight against COVID-19. This product is made indigenously in line with ‘Make in India’ campaign as envisioned by our Hon’ble Prime Minister.”
The drug ‘Remdesivir’ has been granted approval by DCGI for the treatment of suspected or laboratory-confirmed cases of COVID-19 in adults and children, hospitalized with severe symptoms of the disease. COVIFOR (Remdesivir) will be available in 100 mg vial (Injectable) which has to be administered intravenously in a hospital setting under the supervision of a healthcare practitioner.
The product is launched under a licensing agreement with Gilead Sciences Inc. to expand access to COVID-19 treatment in low and middle-income countries.
In a landmark development for COVID-19 patients in India, Glenmark Pharmaceuticals got approval of antiviral drug Favipiravir (brand name FabiFlu®) for the treatment of mild to moderate COVID-19 patients. Glenmark has received manufacturing and marketing approval from India’s drug regulator, making FabiFlu® the first oral Favipiravir-approved medication in India for the treatment of COVID-19.
Favipiravir is backed by strong clinical evidence showing encouraging results in patients with mild to moderate COVID-19. The antiviral offers broad spectrum RNA virus coverage with clinical improvement noted across age groups 20 to >90 years. Favipiravir can be used in COVID-19 patients with co-morbid conditions such as diabetes and heart diseasewith mild to moderate COVID 19 symptoms. It offers rapid reduction in viral load within 4 days and provides faster symptomatic and radiological improvement.Of most importance, Favipiravir has shown clinical improvementof up to 88% in COVID-19 mild to moderate COVID 19 cases.
Glenmark successfully developed the active pharmaceutical ingredient (API) and the formulation for FabiFlu® through its own in-house R&D team.Glenmark filed the product for clinical trial with India’s drug regulator DCGI and became the first pharmaceutical company in India to receive approval for conducting phase 3 clinical trial on mild to moderate COVID-19 patients.
Commenting on the significance of this development, Mr. Glenn Saldanha, Chairman and Managing Director of Glenmark Pharmaceuticals Ltd., said, “This approval comes at a time when cases in India are spiralling like never before,putting a tremendous pressure on our healthcare system. We hope the availability of an effective treatment such as FabiFlu® will considerably help assuage this pressure, and offer patients in India a much needed and timely therapy option.”
He added, “FabiFlu® has demonstrated an encouraging response in mild to moderate COVID-19 patients during clinical trials. Moreover, it is orally administered, and so it serves as a more convenient treatment option over other intravenously administered medications. Glenmark will work closely with the government and medical community to make FabiFlu® quickly accessible to patients across the country.”
Favipiravir is approved in Japan since 2014 for the treatment of novel or re-emerging influenza virus infections. It has a unique mechanism of action: it is converted into an active phosphoribosylated form (favipiravir-RTP) in cells and recognized as a substrate by viral RNA polymerase, thereby inhibiting RNA polymerase activity.
Most patients exhibiting mild to moderate symptoms can benefit from FabiFlu® use.The drug will be available as a prescription-based medicationfor INR 103/tablet,with recommended dose being1800 mg twice daily on day 1, followed by 800 mg twice daily up to day 14.
Earlier last month, Glenmark also announced that it is conducting another clinical trial to evaluate the efficacy of two antivirals Favipiravir and Umifenovir as a combination therapy in moderate hospitalized adult COVID-19 patients in India.
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