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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that incorporate human genome editing (GE) on how best to communicate with the FDA about products in development in a draft guidance released yesterday.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
The European Medicines Agency (EMA) is seeking comments from the public on a draft pharmacovigilance guideline published yesterday on assessing the risk of drug-related fetal abnormalities and when to employ a pregnancy prevention program (PPM) or risk minimization measures (RMM). Read More
Three Democratic representatives from the House Committee on Oversight and Reform sent a letter to the Treasury Department and the Department of Justice (DOJ) Monday, expressing their alarm at certain companies claiming tax benefits from their opioid settlement expenses. Read More
Despite the fact that many states have lifted their mask mandates and the last surge of a COVID-19 variant of concern peaked several weeks ago, we are nowhere near public health officials announcing the end of the public health emergency, according to epidemiologists who track COVID-19. Read More
“The evidence shows antibiotics are not needed by most children and young people with middle ear infections,” said Paul Chrisp, director of NICE’s Center for Guidelines. Read More