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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
The FDA cited B. Braun Medical for failing to complete timely corrective and protective actions (CAPAs) following an inspection of its Irvine, Calif. facility. Read More
The European Medicines Agency’s (EMA) safety committee has begun a review of acute kidney injuries reported in some COVID-19 patients being treated with Gilead Sciences’ remdesivir. Read More
New guidance from the FDA that would set tougher conditions for COVID-19 vaccine Emergency Use Authorizations (EUAs) remains under White House review, and it is unclear when — or if — it may be released. Read More