Policy
Arbutus alleges that Moderna’s COVID-19 vaccine infringes on patents protecting its lipid nanoparticle delivery technology.
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Bristol Myers Squibb, GSK and Merck are contributing drug ingredients as part of their deals with the White House but are keeping many of the terms of their agreements private.
Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
The FDA’s rare pediatric disease priority review voucher program missed reauthorization at the last minute in 2024; advocates have been fighting to get it back ever since.
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The concern relates to the risk of two rare heart inflammation conditions, myocarditis and pericarditis, that have been linked to the Pfizer and Moderna mRNA vaccines.
The U.S. Food and Drug Administration has a few PDUFA dates on its calendar for this week. Here’s a look.
The advisory committee voted 19-0 to recommend the extra dose of the J&J shot for anyone 18 years and older.
Facing thousands of lawsuits related to its talc-based products, life sciences giant Johnson & Johnson is launching a separate subsidiary dubbed LTL Management LLC that will take the brunt of potential legal liabilities.
According to CNN, Califf is being vetted by the administration of Joe Biden, who served as vice president to Obama.
Research on the ever-evolving SARS-CoV-2 virus continues as scientists scramble to make sense of it and find cures. Here’s a look.
Although there are many effective and safe COVID-19 vaccines around the world, the preferred vaccine is the Pfizer-BioNTech vaccine. For that and more stories, read on.
Protagonist Therapeutics announced Monday morning that the FDA had removed the hold on PV drug candidate rusfertide, clearing the way for all trials to resume.
Biden’s campaign trail promise to cure cancer is hanging in the balance as his plan for a new biomedical research agency is being axed from the Democrats’ social spending package.
Two companies reported regulatory submissions to the FDA, and a third reported successful clinical trial data that will form the basis of submission in the coming months.