Policy
Leqembi’s application now moves forward to the European Commission, which will issue a formal verdict for the injection that will apply to all EU member states as well as Norway, Liechtenstein and Iceland.
FEATURED STORIES
Representatives from companies such as Sanofi and Forge Biologics point to the potential for PreCheck to drive activation of idle production capacity and help companies that are already building plants.
The upheaval of the Health and Human Services workforce and leadership leaves much to be desired in terms of delivery, recently retired FDA Chief Information Officer Vid Desai tells BioSpace, but the regulatory agency is evolving to be more open to much needed change.
Having seen Congress spend money to onshore semiconductor production, pharma groups are pushing for similar incentives for domestic drug manufacturing.
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On the heels of the FDA’s denial of its petition, a Delaware district court on Monday handed Novartis another loss in its efforts to keep the market free of Entresto copycats.
At a private event held amid the fallout from the CrowdStrike incident, cybersecurity issues took a front seat, with the consequences of the evolving EU AI Act and the Loper Bright and Corner Post decisions also raising concerns for quality assurance and regulatory affairs professionals.
With Medicare expenditures on Stelara increasing nearly tenfold, a new report from the HHS Office of Inspector General has found major differences in drug payment amounts under Part B versus Part D.
In the latest setback for the pharma industry and its allies, the United States District Court for the Southern District of Ohio dismissed a U.S. Chamber of Commerce lawsuit on the grounds of improper venue.
Lobbying groups and individuals connected with the industry are supporting candidates from both parties, with a particular focus on the future of the 340B discount program and pharmacy benefit managers.
Reiterating his ruling in a prior Inflation Reduction Act case, New Jersey District Court Judge Zahid Quraishi ruled that Novo Nordisk’s participation in the Medicare Drug Price Negotiation Program is of its own free will.
The BIOSECURE Act’s prohibition on doing business with China-based companies may have implications for biotech and biopharma markets on both sides of the Pacific.
With the BIOSECURE Act likely to be voted on in Congress this year, WuXi AppTec’s U.S. revenue dropped 1.2% in the first half of 2024 while the Chinese company increased its lobbying efforts.
The combination therapy is one step closer to becoming a potential new first-line standard of care for patients with unresectable or metastatic urothelial carcinoma in Europe.
Despite their initial kicking and screaming, drugmakers seem confident the Inflation Reduction Act’s Medicare Drug Price Negotiation Program will not greatly impact their bottom lines.