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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Citing anti-trust issues, six states—California, Illinois, Minnesota, New York, Washington and Wisconsin—are joining the FTC’s legal challenge to Amgen’s nearly $27.8 billion buyout of Horizon.
Regeneron envisions new dosing for Eylea’s label and it’s the moment of truth for BioMarin’s gene therapy for hemophilia A. For that and more, see inside.
The government asked a federal judge to overturn a verdict in which a Delaware jury ruled in favor of Gilead, deciding that its preventative HIV drugs Truvada and Descovy did not infringe on its patents.
The FDA’s fiscal year 2022 report on the State of Pharmaceutical Quality also flagged a spike in inspections, non-compliant products and import alerts.
With no well-controlled data to support its efficacy, the FDA rejected Aldeyra’s methotrexate injection for primary vitreoretinal lymphoma.
On the heels of Merck’s and BMS’ lawsuits, the pharma industry’s lobbying group Wednesday filed a complaint in federal court asserting that the price-setting provisions in the Inflation Reduction Act are unconstitutional.
The FDA has approved Jardiance and Synjardy as the first SGLT-2 inhibitors to treat pediatric Type 2 diabetes, providing a new class of oral medicines.
Following an FDA warning in May, Novo Nordisk has filed several lawsuits against spas, clinics and pharmacies selling compounded version of semaglutide.
An International Chamber of Commerce arbitration tribunal has dismissed Boehringer’s attempt to seek indemnification from Sanofi for the ongoing Zantac lawsuits faced by the companies.
Biopharma executives suggested that some companies might seek to bypass the U.S. government’s national health insurance program altogether, among other sweeping changes to drug development.