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.
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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 regulator concluded that Prolia (denosumab) increases the risk of severe hypocalcemia, which may result in hospitalization and could trigger life-threatening events or even lead to death.
Amit Dagar, a former Pfizer employee, was found guilty of insider trading by a federal jury in New York involving clinical trial results for COVID-19 antiviral Paxlovid that he profited from.
The pharma execs may be served with subpoenas to appear before the Senate health committee to explain why their products are much more expensive in the U.S. than in other countries, according to chairman Sen. Bernie Sanders.
A legislative proposal, if passed into law, could cost the United States up to 1.2 million jobs and lead to more than 130 fewer FDA approvals over a 10-year period, according to a new report.
CBER Director Peter Marks recently spoke in favor of single-arm trials in certain situations, but clinicians and ethicists say there are several variables to consider.
Regulatory authorities worldwide are tightening their monitoring mechanisms and launching their own investigations after reports of secondary malignancies potentially linked to chimeric antigen receptor T cell therapies.
The FDA’s Complete Response Letter identified problems with the drug candidate’s chemistry, manufacturing and controls, parent company Shin Nippon Biomedical Laboratories announced Thursday.
The U.S. Patent and Trademark Office has sided with Daiichi over Seagen in a years-long patent saga concerning a key linker technology used in its blockbuster Enhertu antibody-drug conjugate for cancer.
Delaware Chancery Court Judge Paul Fioravanti on Tuesday ordered activist investor Carl Icahn to remove confidential information from his lawsuit against legacy Illumina board members.
After a quiet start to 2024, the FDA is expected to decide on three applications over the next two weeks, including one for a nasal powder migraine treatment.