FDA Authorizes Pfizer/BioNTech COVID-19 Shot for Children
The FDA on Friday granted an updated Emergency Use Authorization (EUA) for the Pfizer/BioNTech COVID-19 vaccine for use in children ages five to 11 years — following a thumbs up…
Cortexyme Bets on P. Gingivalis Toxin Disrupter to Slow Alzheimer’s Progression
Cortexyme isn’t letting a missed primary endpoint stifle its conviction that P. gingivalis, the bacteria that causes periodontal disease, is a root cause of Alzheimer’s disease (AD) and that its…
Democrats Make Last-Ditch Effort to Include Drug Pricing Reform in Spending Bill
Since President Biden abandoned any provisions seeking to reduce prescription drug prices in the approximately $1.75 trillion Build Back Better bill framework unveiled last week, Democratic lawmakers have been trying…
FDA Posts Final Guidance on Submitting Reports of Number of Drugs Distributed
The FDA details how drugmakers should submit reports on the number of drugs they have distributed in a final guidance released Friday. Source: Drug Industry Daily
FDA Could Get $300 Million for Infrastructure in Build Back Better Package
The FDA is slated to receive a one-time infusion of $300 million to upgrade its physical and technological infrastructure, according to the updated text of the proposed $1.75 trillion Build…
FDA Releases GDUFA III Commitment Letter
The FDA has released its commitment letter for the reauthorization of the Generic Drug User Fee Act (GDUFA), hammered out over several meetings with industry this year. Source: Drug Industry…
FDA Dings Sesen Bio for Misconduct by Study Investigator
Sesen Bio received an FDA warning letter Oct. 27, knocking the company over a 4-year-old personnel issue that came to light in a recent biologics license application (BLA) review of…
Takeda Strengthens Its CAR-T Platform With GammaDelta Therapeutics Acquisition
Takeda Pharmaceuticals is expanding its off-the-shelf CAR-T cell program yet again, with the acquisition of GammaDelta Therapeutics, a company researching the unique abilities of gamma delta T-lymphocytes to attack blood…
FDA Seeks Feedback on Research Plan on ‘Targeted’ Mechanism of Action Ads
The FDA’s Office of Prescription Drug Promotion (OPDP) is aiming to understand how “targeted” mechanism of action (MoA) advertising affects how healthcare workers and consumers view a drug and is…
Novartis Hit With Subpoena From DOJ Over Marketing and Pricing of Heart Drug Entresto
Novartis has received a request from the Department of Justice (DOJ) asking for information about the marketing and pricing of Entresto, the company’s blockbuster combination sacubitril/valsartan drug for heart failure.…