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AbbVie and Cerevel Therapeutics announced that AbbVie will buy Cerevel Therapeutics and its neuroscience pipeline of schizophrenia, Parkinson's disease, and mood disorder drugs that are in multiple clinical and preclinical stages for $8.7 billion. Read More
Drug containers contaminated with wood, cellulose, brass and steel as well as multiple corrective and preventive actions (CAPA) to address mold are among the reasons the FDA listed in its untitled letter to Novartis Pharmaceuticals over its biological product Kymriah (tisagenlecleucel). Read More
After agreeing to a voluntary plan to help lower drug prices in the UK, the Association of the British Pharmaceutical Industry (ABPI) has issued a statement today accusing the UK government and England’s National Health Service (NHS) of sending mixed messages to life science companies. Read More
Upcoming events in the coming weeks and months include two FDA advisory committee meetings; MAGI 2024: The Clinical Research Conference; and webinars on overcoming common clinical trial challenges, supplier quality agreements and FDA inspections. Read More
In 2022, FDA inspections of both foreign and domestic drug manufacturing plants were still far below pre-COVID-19 pandemic levels, although the number of citations soared, a new study has found. Read More
After agreeing this fall to participate in the Inflation Reduction Act (IRA) drug price negotiation program, AstraZeneca — whose type 2 diabetes therapy Farxiga (dapagliflozin) was among the first 10 drugs singled out for the new cost-cutting measure — is still fighting the government over the program. Read More
The House Subcommittee on Health Care and Financial Services has asked the FDA to schedule a briefing with Committee staff no later than Dec. 11 to help with an investigation of the efficacy of OTC drugs after an advisory committee concluded that a commonly used decongestant, phenylephrine, is ineffective. Read More
Aggressively using all the FDA’s regulatory flexibility to advance burgeoning treatments for rare diseases, particularly gene therapy, was a theme highlighted Monday by CBER Director Peter Marks. Read More
Roche has announced the $2.7 billion acquisition of Carmot Therapeutics, including that company’s three potential incretin obesity and diabetes drugs. Read More