Industry News

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 Dasatinib Tablets, 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg. The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Sprycel Tablets, 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg, of Bristol Myers Squibb Company (BMS).

Amneal Pharmaceuticals, Inc.announced that the U.S. Food and Drug Administration has approved the Company’s Biologics License Applicationfor pegfilgrastim-pbbk, a biosimilar referencing Neulasta. The product will be marketed under the proprietary name FYLNETRA.

Pfizer Inc announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Pfizers investigational combination therapy for the treatment of non-alcoholic steatohepatitis (NASH) with liver fibrosis: ervogastat (PF-06865571, a diacylglycerol O-acyltransferase 2 inhibitor, or DGAT2i) and clesacostat (PF-05221304, an acetyl-CoA carboxylase inhibitor, or ACCi).

Ahmedabad based Torrent Pharmaceuticals announced that it has entered into an agreement with Dr. Reddy's Laboratories Ltd. to acquire four of its brands "Styptovit-E", "Finast", "Finast-T", and "Dynapress".

A Mumbai-based pharmaceutical company Medley Pharma is up for sale and is expected to be sold for Rs 5,000 crore in a deal. According to a report in Times of India, drug giants Cipla, Dr Reddy's Lab, JB Chemicals, and Torrent, as well as prominent private equity firms Advent, Carlyle, and Blackstone, are all interested in buying the Rs 1,000-crore business.

Johnson & Johnson and Momenta Pharmaceuticals have filed a lawsuit against NATCO and its marketing partner Mylan Pharmaceuticals & others alleging infringement of two old Patents associated with 20mg per ml and 40mg per ml Glatiramer Acetate Injection.

Zydus Lifesciences Ltd has received final approval from the United States Food and Drug Administration (USFDA) to market Pemetrexed for Injection, in the strengths of 100 mg/vial,500 mg/vial, and 1000 mg/vial Single-Dose Vials (USRLD: Alimta). Pemetrexed is used to treat certain types of cancers such as lung cancer, mesothelioma.

Novartis announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for Cosentyx (secukinumab), used alone or in combination with methotrexate, in the juvenile idiopathic arthritis (JIA) categories of enthesitis-related arthritis (ERA) and juvenile psoriatic arthritis (JPsA) in patients 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy.

LumiraDx Limited a next-generation point of care diagnostics company, announced today that its rapid COVID-19 antigen assay, LumiraDx SARS-CoV-2 Ag Test has successfully received the Emergency Use Listing (EUL) by the World Health Organization (WHO) in their latest response effort to combat COVID-19.