Industry News

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.

PCI Pharma Services (PCI), a leading global contract development and manufacturing organization (CDMO) announced a major expansion of capabilities and capacity in aseptic liquid fill-finish and sterile lyophilization technology, an important manufacturing process commonly used with injectable and biologic therapies, with the investment of 100 Million USD into the construction and enhancement of world-class facilities, at its Bedford, New Hampshire campus.

Aurobindo Pharma receives 6 observations after inspection of Aurobindo Pharma Jedcherla plant.

The United States Food and Drug Administration (US FDA) inspected Aurobindo Pharma's Unit VII, an oral manufacturing facility situated at Jedcherla, Hyderabad, from 2nd to 10th May 2022.