Belcher Pharmaceuticals received a Form 483 from the FDA for several deficiencies observed during a Nov. 1- 15, 2021, inspection of its drug manufacturing facility in Largo, Fla. Source: Drug…
New York-based drug discovery company Volastra Therapeutics has signed a deal with Bristol Myers Squibb (BMS) potentially worth up to $1.1 billion to create new medicines for undisclosed targets. Source:…
Baxter Pharmaceuticals Solutions’ contract manufacturing facility in Bloomington, Ind., has received a Form 483 for several deficiencies observed during an FDA inspection from Nov. 2 through Nov. 10, 2021. Source:…
The FDA won’t weigh in on whether Regenxbio may be granted a patent extension for its adeno-associated virus (AAV) technology used to produce Novartis’ blockbuster spinal muscular atrophy (SMA) therapy…
The rare inherited condition Fabry Disease (FD) may soon have a new treatment. Source: Drug Industry Daily
Bristol Myers Squibb (BMS) is accusing AstraZeneca of infringing on several patents related to its blockbuster cancer immunotherapy Opdivo (nivolumab). Source: Drug Industry Daily
The FDA has issued a warning letter to Boca Raton, Fla.-based Iotech International for making unsupported claims for its antiseptic mouthwash and iodine-containing hand sanitizers. Source: Drug Industry Daily
Merck’s mega blockbuster Keytruda (pembrolizumab) may soon have a new indication, this time in an earlier stage of disease than is typical for the anti-PD-L1 therapy. Source: Drug Industry Daily
The European Medicines Agency’s (EMA) safety committee has recommended revised product safety information for Johnson & Johnson’s (J&J) and Moderna’s COVID-19 vaccines. Source: Drug Industry Daily
Deep decreases from high baseline tau levels were associated with the best clinical response in patients who responded to Aduhelm during clinical trials, according to new data presented at the…