COVID-19 vaccine makers appearing yesterday before a U.S. House subcommittee pledged to lawmakers they would meet — and in some cases accelerate — their vaccine supply commitments, as the federal government and states clamor for more doses one year into the pandemic. Read More

The FDA’s Office of Clinical Pharmacology’s strike teams were directly involved in the agency’s efforts to battle the COVID-19 pandemic in 2020, according to an annual report it published Monday. Read More

The FDA has published draft guidance letting COVID-19 vaccine developers that modify authorized vaccines against new viral variants know what they need to present to the agency for amending Emergency Use Authorizations (EUAs), noting that it doesn’t expect large-scale trials will be needed for the altered versions. Read More

In the latest in a series of recent moves that greatly expand its presence in cell and gene therapies, Charles River Laboratories is acquiring Cognate BioServices, a Baltimore, Md.-based cell and gene therapy contract development and manufacturing firm for $875 million. Read More

A federal judge has dismissed a lawsuit filed by hospital associations against HHS aimed at compelling it to take action against drugmakers who decline to offer 340B drug discounts to contract pharmacies. Read More

A U.S. appeals court judge this week issued an emergency stay of a December ruling by the U.S. International Trade Commission that the import, sale and marketing of a competitor to AbbVie ’s Botox wrinkle treatment, Jeuveau, must be stopped for nearly two years. Read More

Several U.S. states are pursuing their own versions of drug pricing policies introduced by the previous administration that would link the price of some prescription drugs to those in other “reference” countries. Read More

The number of clinical trials that make it through to regulatory approval over the past decade is less than 8 percent, according to a new report on clinical success rates. Read More

The EU yesterday unveiled a plan to speed up regulatory approvals and manufacturing of vaccines against emerging strains of the SARS-CoV-2 virus that causes COVID-19. Read More

Acting FDA Commissioner Janet Woodcock rejected a proposal to put up a “firewall” between FDA staff involved in pre-submission interactions and staff working on post-submission drug and biologic reviews and decisions, defending the agency’s collaboration with sponsors as critical to the development process. Read More