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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. Read More
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 Zolgensma (onasemnogene abeparvovec). Read More
Bristol Myers Squibb (BMS) is accusing AstraZeneca of infringing on several patents related to its blockbuster cancer immunotherapy Opdivo (nivolumab). Read More
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. Read More
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. Read More
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 Alzheimer’s Disease/Parkinson’s Disease 2022 international conference last week in Barcelona, Spain. Read More
Moderna and Pfizer/BioNTech are both pushing to get expanded Emergency Use Authorization (EUA) for a fourth dose/second booster of their COVID-19 vaccines, but a new study questions its effectiveness in the population at large. Read More