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3 February 2021

Gilead Sciences and Gritstone Collaboration Utilizing Gritstone’s Vaccine Platform Technology for HIV Cure

Gilead Sciences, Inc and Gritstone Oncology, Inc a clinical-stage biotechnology company developing next generation cancer and infectious disease immunotherapies, today announced that the companies have entered into a collaboration, option and license agreement to research and develop a vaccine-based immunotherapy as part of Gilead’s efforts to find a curative treatment for human immunodeficiency virus (HIV) infection.
28 January 2021

Zydus granted Orphan Drug Designation by the USFDA for Saroglitazar in the treatment of patients with Primary Biliary Cholangitis (PBC)

United States Food and Drug Administration (USFDA) has granted ‘Orphan Drug Designation’ (ODD) to Saroglitazar for the treatment of patients with Primary Biliary Cholangitis (PBC). Orphan drug designation provides eligibility for certain development incentives, including tax credits for qualified clinical testing, prescription drug user fee exemptions and seven-year marketing exclusivity upon FDA approval. This follows the grant of ‘Fast Track Designation’ by the USFDA to Saroglitazar Mg for PBC in December 2020.
22 January 2021

FDA approves Cabenuva as long acting regimen of HIV treatment

ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc with Pfizer Inc. and Shionogi Limited as shareholders, announced that the US Food and Drug Administration (FDA) approved Cabenuva, the first and only complete long-acting regimen for the treatment of HIV-1 infection in adults.
20 January 2021

NextPharma Set to Acquire Two Lonza Sites Specialized in Lipid Oral Dosage Forms

“NextPharma is an established and well-respected company, with extensive experience in oral and topical finished dosage forms. As such, it is the ideal buyer given the technologies available at the Ploermel and Edinburgh sites. We are confident that the capabilities and experience at the two sites are a complementary fit with NextPharma’s portfolio and that it is ideally placed to develop both to their full potential.
12 January 2021

Sanofi to acquire Kymab

Sanofi and Kymab, a clinical-stage biopharmaceutical company developing fully human monoclonal antibodies with a focus on immune-mediated diseases and immuno-oncology therapeutics, have entered into an agreement under which Sanofi will acquire Kymab for an upfront payment of approximately USD 1.1 billion and up to 350 million upon achievement of certain milestones.
23 December 2020

WuXi Biologics to Acquire Drug Substance Facility in Wuppertal, Germany from Bayer

WuXi Biologics a global company with leading open-access biologics technology platforms, and Bayer, announced an acquisition deal, under which WuXi Biologics will take over and operate the Drug Substance (DS) facility at Bayer’s Wuppertal site. The companies also plan to enter into a long-term sublease agreement and a transition service contract. The volume of the transaction, including the sublease agreement, amounts to approximately 150 million euros.
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.

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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.”

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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.

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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.

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