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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
There’s a push by congressional Democrats to get President Biden to issue a host of executive orders as soon as possible on key priorities, including drug pricing, because they’re not convinced they can get legislation passed before the November midterms. Read More
Alnylam Pharmaceuticals is suing both Pfizer and Moderna in separate suits, alleging that both companies’ COVID-19 vaccines infringe on one of Alnylam patents for technology that allows RNA-based therapeutics or vaccines to be delivered safely into the body. Read More
Gilead Sciences has become the 15th major drugmaker to limit its involvement with the 30-year-old 340B Drug Discount Program that was designed to serve low-income patient populations in the U.S. Read More
The FDA has advised sponsors of gene therapy products that incorporate human genome editing (GE) on how best to communicate with the FDA about products in development in a draft guidance released yesterday. Read More