Policy
The U.S. regulator shared the roadmap for implementing the program, first proposed in August 2025, and teased changes made in response to industry feedback.
FEATURED STORIES
Former European Trade Commissioner Phil Hogan and former US Senator Richard Burr, speaking on a panel at the J.P. Morgan Healthcare Conference, pushed to see a larger picture beyond the Trump administration’s year of chaos and confusion.
Only a handful of the top pharmas have signed Most Favored Nation drug pricing deals with the White House, while smaller biotechs continue to hang in limbo.
Policy initiatives have come fast and furious at the FDA this year. While guidances on rare diseases and vaccines have consumed most of the ink, policy shifts aimed at improving FDA efficiencies and reshoring U.S. manufacturing also got some attention. Here, BioSpace rounds up more than a dozen initiatives relevant to the biopharma industry.
Subscribe to BioPharm Executive
Market insights and trending stories for biopharma leaders, in your inbox every Wednesday
THE LATEST
“Today’s announcement outlines two pathways for the safe importation of certain prescription drugs to help provide safe, effective, more affordable drugs to American patients,” said Alex Azar, Secretary of HHS.
The FTC alleges that Illumina is trying to unlawfully maintain a monopoly in the U.S. market for next-generation DNA sequencing systems by removing PacBio as a competitive threat.
Follows recent study results showing CelGro® facilitates high quality nerve repair and restores function to previously paralysed muscles
Baebies is pleased to announce that FINDERTM, a near-patient testing platform, now has CE Mark as an In Vitro Diagnostic device and is commercially available in Europe and other countries that recognize CE Mark.
With the latest approval, Xtandi, an androgen receptor inhibitor, is now the only oral treatment approved by the FDA for three distinct types of advanced prostate cancer – non-metastatic and metastatic castration-resistant prostate cancer (CRPC) and mCSPC.
If approved by the European Commission, the daratumumab-VTd regimen would represent the first therapeutic option indicated for newly diagnosed patients who are eligible for a stem cell transplant in six years
Positive Opinion is based on data from the Phase 3 TITAN study which were published in The New England Journal of Medicine
PharmaMar shall receive an upfront payment and is eligible for additional remunerations, including regulatory milestone payments.
PERTH, AU, Dec 13, 2019 - - Holista CollTech announced that it has filed its 100%-owned global patent for platform technology that will deliver many fat-soluble medications by creating a water-soluble delivery system.
Dublin-based Avadel Pharma announced that the U.S. Food and Drug Administration had approved its Nouress for neonatal patients requiring total parenteral nutrition.