Industry News

Glenmark Pharmaceuticals Limited a global, innovation-driven pharmaceutical company and Canadian pharmaceutical company SaNOtize Research & Development Corp. today announced launch of its Nitric Oxide Nasal Spray under the brand name FabiSpray in India; for the treatment of adult patients with COVID-19 who have high risk of progression of the disease. Glenmark earlier received manufacturing and marketing approval from the Drugs Controller General of India (DCGI) for NONS as part of the accelerated approval process.

The U.S. Food and Drug Administration FDA has approved Enjaymo sutimlimab-jome to decrease the need for red blood cell transfusion due to hemolysis in adults with cold agglutinin disease CAD. Enjaymo is the first and only approved treatment for people with CAD and works by inhibiting the destruction of red blood cells hemolysis.

Medidata, a Dassault Systèmes company, announced today that Parexel, a leading global clinical research organization (CRO) focused on development and delivery of innovative new therapies to advance patient health, is extending their 15-year global strategic partnership. This builds upon the trusted relationship between the two companies and sets the goal of jointly pioneering a new era of decentralized clinical trial technology (DCT) for the life sciences industry.

Dr. Reddy's Laboratories Ltd announced that it has entered into a definitive agreement to acquire Nimbus Health GmbH. Nimbus Health is a privately owned, licensed pharmaceutical wholesaler from Germany focusing on medical cannabis in Germany. Dr. Reddy's will acquire Nimbus Health for an upfront payment plus performance and milestone-based earn-outs over the next four years.

The U.S. Food and Drug Administration has approved the first generic of Restasis (cyclosporine ophthalmic emulsion) 0.05% single-use vials (eye drops) to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca (commonly known as dry eye). Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs.

Nuvaxovid, the COVID-19 vaccine developed by Novavax, has today been given regulatory approval by the Medicines and Healthcare products Regulatory Agency (MHRA).  Nuvaxovid becomes the fifth COVID-19 vaccine authorised by the UK’s independent medicines regulator.

GlaxoSmithKline plc announced that ViiV Healthcare, the global specialist HIV company majority-owned by GSK, with Pfizer Inc. and Shionogi & Co. Limited Shionogi as shareholders, has agreed to settle the global patent infringement litigation between GSK, Shionogi and Gilead Sciences, Inc. Gilead concerning ViiV Healthcares patents relating to dolutegravir, an antiretroviral medication used, together with other medicines, to treat human immunodeficiency virus.

Pfizer Inc and BioNTech SE announced that following a request from the U.S. Food and Drug Administration the companies have initiated a rolling submission seeking to amend the Emergency Use Authorization of the Pfizer-BioNTech COVID-19 Vaccine to include children 6 months through 4 years of age 6 months to <5 years of age, in response to the urgent public health need in this population. The companies expect to complete the EUA submission in the coming days.

Alembic Pharmaceuticals Limited announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Fesoterodine Fumarate Extended- Release Tablets, 4 mg and 8 mg. The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Toviaz Extended-Release Tablets, 4 mg and 8 mg, of Pfizer Inc. (Pfizer).