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The UK’s National Institute for Health and Care Excellence (NICE) is considering changes to how it evaluates the cost-effectiveness of medicines and is inviting public comment. Read More
The European Commission has approved AstraZeneca’s leukemia drug Calquence (acalabrutinib) for the treatment of adults with chronic lymphocytic leukemia (CLL). Read More
Rick Bright, who was leading the vaccine effort at NIH’s Biomedical Advanced Research and Development Authority (BARDA) but was pushed aside by the Trump administration, has joined President-Elect Joe Biden’s Transition COVID-19 Advisory Board. Read More
As Novavax gears up to put its investigational COVID-19 vaccine through a phase 3 U.S. trial this month, the FDA has granted the candidate a Fast-Track designation in order to speed up its regulatory review process. Read More
Pfizer and BioNTech have pulled ahead to become the frontrunners in the race for a COVID-19 vaccine, announcing that the first interim analysis from their late-stage trial showed the candidate was more than 90 percent effective. Read More
An FDA inspection of Romark Global Pharma’s Manati, Puerto Rico drug manufacturing facility revealed problems with contamination of drug products and equipment. Read More
The FDA has published final guidance designed to help drug compounders recognize, prevent and respond to insanitary conditions at their facilities. Read More
One arm of the UK’s RECOVERY trial evaluating potential COVID-19 treatments is including aspirin in combination with the drugs being evaluated. Read More