Pharma News, 2022

Centrient Pharmaceuticals’ active pharmaceutical ingredient (API) facility in Punjab, India, received a warning letter from the FDA for multiple deficiencies including lax records, test validatio...

A decision is anticipated in early January about which of the now eight Humira biosimilars will be included.

For years, Alexion has been the only name in the game for a blood disease called paroxysmal nocturnal hemoglobinuria (PNH). 

The Food and Drug Administration (FDA) has granted Fast Track designation to PH10 for the treatment of major depressive disorder (MDD). 

The United States Pharmacopeia (USP) and Phlow have teamed up to develop a new lab that will certify and validate pharmaceutical continuous manufacturing processes to facilitate the supply of U.S.-...

Cytokinetics’ omecamtiv mecarbil received an 8-3 thumbs-down from the FDA’s Cardiovascular and Renal Drugs Advisory Committee, with the majority agreeing that the risks of the myosin activator out...

The U.S. government has inked a purchase deal with Pfizer for almost $2 billion for an additional 3.7 million courses of Paxlovid (nirmatrelvir, ritonavir), the company’s oral COVID-19 drug. ...

The mRNA technology that was deployed so effectively in vaccines against COVID-19 has now been found to offer similar promise against cancer, according to Merck & Co and Moderna. ...

The Association of the British Pharmaceutical Industry (ABPI) has cited six companies — Novo Nordisk, Daiichi-Sankyo, Lundbeck, AstraZeneca, UCB and Biogen — for breaching its self-regulated co...

The FDA has granted accelerated approval to Mirati Therapeutics’ Krazati (adagrasib) for treatment of adults with KRAS G12C-mutated locally advanced or metastatic nonsmall-cell lung cancer (NSCLC...

A new initiative to boost research and development into rare and paediatric diseases launched last week, on Thursday 8th December, at the European Health Summit.

The professor of medicine at the University of Manitoba discussed the need to change how multiple sclerosis is characterized, and how aging contributes to increased disease progression.  ...