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The FDA’s Office of Prescription Drug Promotion (OPDP), which has only issued a handful of warning letters so far this year, sent out two on the same day to drugmakers in South Carolina and New Jersey. Read More
The FDA is calling for AMAG Pharmaceuticals to withdraw its preterm birth injection Makena (hydroxyprogesterone caproate), as well as its generics, from the market after a postmarket study failed to demonstrate efficacy. Read More
The HIV-1 antiviral drug combination lopinavir-ritonavir, marketed by AbbVie under the brand name Kaletra, has shown no benefit in reducing all-cause mortality among patients hospitalized with COVID-19 in the UK’s RECOVERY trial. Read More
The European Medicines Agency (EMA) began its second expedited review of a COVID-19 vaccine candidate, starting its evaluation of data for Pfizer/BioNTech’s vaccine hopeful BNT162b2 on Tuesday. Read More
GlaxoSmithKline (GSK) and Vir Biotechnology have begun enrolling participants in phase 3 trials to assess the safety and efficacy of their monoclonal antibody, VIR-7831, in treating COVID-19 infections early on in high-risk patients. Read More
Rick Bright, the former director of NIH’s Biomedical Advanced Research and Development Authority (BARDA), has resigned from the institute, alleging that its leadership failed to assign him meaningful work and ignored his recommendations because of politics. Read More
Despite the White House reportedly blocking the FDA’s tighter requirements for COVID-19 vaccine Emergency Use Authorizations (EUAs), the agency has opted to release them. Read More
Teva Pharmaceuticals is back on the hook for $235 million in damages for infringing on GlaxoSmithKline’s patent for its blood pressure drug Coreg (carvedilol), thanks to a federal appeals court ruling. Read More
The deal gives BMS mavacamten, MyoKardia’s investigational treatment for obstructive hypertrophic cardiomyopathy, a chronic heart disease afflicting up to 200,000 individuals in the U.S. and the EU. Read More