Policy
An unnamed FDA official also told reporters that it would be good for Moderna to “show some humility” and admit that it didn’t follow the regulator’s recommendations in testing its mRNA flu vaccine.
FEATURED STORIES
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 Trump administration has launched a sweeping federal review on the use of fetal tissue that includes the cancellation of a contract between a supplier and researchers at the U.S. Food and Drug Administration.
For the first time in Europe, a pegylated G-CSF biosimilar pegfilgrastim will be available to patients for the treatment of neutropenia
Politicians might deny climate change, but disease-carrying insects and their pathogens aren’t—they’re exploiting it.
Making the jump from biotech to politics may not seem like a typical career progression. So, what is driving these executives into politics?
Recently, a few companies and government programs have decided to enact their own plans that they believe will help bring down the cost of new therapies. Pharmaceutical companies have begun asserting their positions on the topic.
Aridis Pharmaceuticals, headquartered in San Jose, California, announced it had added broad patent coverage of two of its product candidate monoclonal antibodies.
Epizyme, an innovative epigenetic therapy development company, announced this morning that the U.S. Food and Drug Administration has removed their former partial clinical hold reported in April of this year.
Palantir Technologies announced today that it has been awarded a three-year, $7 million contract by the National Institutes of Health (NIH).
Cinfa Biotech today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorization for Pelmeg® (B12019)
The U.S. Food and Drug Administration (FDA) has a few target action dates scheduled for this week, including one for Sunday, September 23, which was approved in late August.