Policy
GenAI, the youngest of the AI family, is evolving quickly. The global life sciences industry is attempting to evolve with it. However, as a keynote session at DIA’s MASC suggests, taking a pause to understand AI risks and to prepare to comply with the EU AI Act is what is needed.
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.
Subscribe to BioPharm Executive
Market insights and trending stories for biopharma leaders, in your inbox every Wednesday
THE LATEST
Monitoring rebates from drugmakers will be critical as provisions of the Inflation Reduction Act are implemented, including drug price negotiations, the Government Accountability Office contends.
With several of the first 10 selected drugs facing patent expirations and generic competition, the drug price negotiations dictated by the IRA may not greatly affect revenues. But that could change quickly.
The Swiss pharmaceutical company filed a suit Friday joining a growing group of legal complaints by Big Pharma seeking to block the Inflation Reduction Act’s Drug Price Negotiation Program.
$27.8B Amgen-Horizon deal gets FTC clearance with restrictions; the White House names first 10 drugs subject to Medicare price negotiations; Sage Therapeutics axes 40% of staff.
Under a consent order agreement announced Friday, Amgen is prohibited from bundling any of its products with Horizon’s Tepezza or Krystexxa, allaying the FTC’s primary concerns.
Two Democratic senators on Thursday sent a letter to the companies’ CEOs informing them that they have until Sept. 15 to disclose the application processes for their insulin assistance programs.
After shoring up quality control at its Reykjavik manufacturing facility, the biotech has resubmitted a BLA to the FDA seeking an interchangeability designation for its Humira biosimilar.
The settlement, announced Wednesday, ends a three-year legal battle allowing Teva Pharmaceuticals to make a generic version of Alkermes’ alcohol and opioid dependence drug Vivitrol.
In this special report, BioSpace examines how the biopharma industry is grappling with impending consequences of the Inflation Reduction Act.
However, a lack of regulatory harmonization risks undermining the effective implementation of these technology-driven approaches.