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The federal government could invoke a clause of patent law designed for wartime to use drug companies’ intellectual property to combat the COVID-19 pandemic, says an attorney experienced in this area — while others say the same tool could help the government lower drug prices. Read More
The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has begun a rolling review of Regeneron’s REGN-COV2 antibody combination (casirivimab/imdevimab) for treating and preventing COVID-19. Read More
AstraZeneca (AZ) has promised to deliver an additional 9 million doses of its vaccine to EU member states during the first quarter of this year, bringing its total delivery for the period up to 40 million — but still only half of the initial 80 million-dose commitment in its contract with the bloc. Read More
A “streamlined” process for authorizing COVID-19 vaccines modified to address significant new coronavirus strains is in the works to enable the FDA to quickly react to significant viral mutations, said Center for Biologics Evaluation and Research (CBER) Director Peter Marks. Read More
The Biden administration has moved to delay until January 2023 the implementation of a key Trump-era policy that would effectively bar pharma companies and pharmacy benefit managers (PBMs) from negotiating prescription drug rebates. Read More
Prescription drug prices that Americans pay are 156 percent higher than the combined average in 32 other countries that are also members of the Organization for Economic Co-operation and Development (OECD), the RAND Corporation has reported in an HHS-funded study. Read More
The FDA has delayed its review of Biogen and Eisai’s highly anticipated Alzheimer’s treatment candidate aducanumab, pushing back its action date to June 7 after deciding it needs more time to review additional analyses and clinical data from the drugmakers. Read More
French vaccine company Valneva said it has begun production of its investigational COVID-19 vaccine, which is now in a phase 1/2 clinical trial in the UK. Read More