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 proposed regulatory framework provides a tougher stance on mergers, impacting industries such as biopharma where the FTC’s recent lawsuit seeks to block Amgen’s Horizon Therapeutics buy.
The Federal Trade Commission and the company had been in settlement discussions, but those talks have ended as the agency’s antitrust lawsuit seeks to block the Horizon Therapeutics sale.
Republican lawmakers have called on the Food and Drug Administration to explain its foreign inspection programs for drug manufacturers in China and India as shortages continue in the U.S.
Johnson & Johnson and Astellas are the latest companies to file suits against the Biden administration, challenging the constitutionality of the Inflation Reduction Act’s Drug Price Negotiation Program.
J&J, Merck and Pfizer are the subjects of a House Judiciary Committee investigation for their alleged participation in a government-sanctioned censorship campaign during the COVID-19 pandemic.
Industry advocates argue price negotiation via the IRA may jeopardize the prices relied upon by biosimilar manufacturers to recoup their investments.
Following the full approval of Leqembi, the CMS suggests expanding its coverage of beta-amyloid PET scans, which could improve the uptake of novel Alzheimer’s disease treatments.
The U.S. regulator Monday approved the Beyfortus single-dose monoclonal antibody, developed jointly by the two companies, for the pediatric prevention of respiratory syncytial virus.
The Federal Trade Commission is asking for more information regarding Pfizer’s planned $43 billion acquisition of Seagen, according to the latter’s Securities and Exchange Commission filing on Friday.
This week: Cancer license deals from J&J and BeiGene, a potential $7B acquisition by Roche and confirmed $1.9B Lilly buy, EU fine for Illumina, and more legal challenges to the Inflation Reduction Act