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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
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
Regulatory approval “should be based on an independent scientific assessment of the balance of benefits and risks,” the joint statement said. 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
Biogen and the FDA failed to convince an advisory committee in a crucial meeting Friday that the company’s potential blockbuster Alzheimer’s drug aducanumab has shown enough evidence of effectiveness. Read More
Although specialty drugs make up only a small fraction of the total retail prescriptions filled in the U.S., they accounted for 37.7 percent of retail and mail-order prescription net spending from 2016 to 2017 even with rebates factored in, a new analysis has found. Read More
The FDA is expected to support Biogen’s potential blockbuster Alzheimer’s drug aducanumab today in a crucial advisory committee meeting today. Read More
The bitterly fought U.S. presidential battle may drag on for some time if the results are contested, but should Democrat Joe Biden emerge victorious, his administration is expected to take a more hands-off approach to the FDA on COVID-19 vaccines and therapeutics. Read More
Many of the guidance documents for drug developers and manufacturers that the FDA has issued during the COVID-19 pandemic are likely to continue to be in effect long after the public health emergency has passed, said Keith Webber, a former official in the FDA’s Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research. Read More