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).

A blood clot in the brain that blocks the supply of oxygen can cause an acute stroke. In this case, every minute counts. A team from Empa, the University Hospital in Geneva and the Hirslanden Clinic is currently developing a diagnostic procedure that can be used to start a tailored therapy in a timely manner, as they write in the current issue of the scientific journal Scientific Reports.

Merck, known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics today announced the Annals of Internal Medicine has published additional data from the Phase 3 MOVe-OUT trial evaluating LAGEVRIO™ (molnupiravir), an investigational oral antiviral medicine, in non-hospitalized adults with mild to moderate COVID-19 who were at high risk for progressing to severe disease.

A vaccine for eastern equine encephalitis virus (EEEV), western equine encephalitis virus (WEEV), and Venezuelan equine encephalitis virus (VEEV) was found to be safe, well-tolerated and induced a neutralizing antibody response in adult volunteers, according to newly published results from a Phase 1 clinical trial. The vaccine candidate was developed by scientists at the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center (VRC), part of the National Institutes of Health.

Individuals with HIV who began taking antiretroviral therapy (ART) in the early stages of infection achieved a lengthy period of HIV suppression without ART after receiving two broadly neutralizing anti-HIV antibodies (bNAbs), according to a small study published today in the journal Nature. The findings suggest that combination bNAb therapy might offer a future alternative to daily ART for people living with HIV.

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.