Industry News

The U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) as an add-on maintenance treatment for children aged 6 months to 5 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. The target action date for the FDA decision on this investigational use is June 9, 2022.

IIHMR University, Jaipur on Wednesday inaugurated its 26th Pradanya Annual Global Conference on Innovations in Healthcare and Education: The Decade of Acceleration for Global Goals, a 3-day conference attended by 30 speakers from 25+ country and over 2000 delegates. Dr. P.R. Sodani, President, IIHMR University welcomed the guest, speakers, and delegates in the inaugural session and introduced the conference theme and tracks to the audience. Dr.

Global pharma major Lupin Limited announced that it has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application, Arformoterol Tartrate Inhalation Solution 15 mcg (base)/2 ml, Unit-dose Vials to market a generic equivalent of Brovana ® Inhalation Solution, 15 mcg /2 ml of Sunovion Pharmaceuticals Inc. (Sunovion).

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.