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.
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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.
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Pharming Group N.V. announced it has received European Medicines Agency approval of a Type II Variation for a new production facility for the Company’s lead product, RUCONEST®.
AstraZeneca’s Imfinzi (durvalumab) and tremelimumab were granted Orphan Drug designation by the U.S. Food and Drug Administration as a possible treatment for hepatocellular carcinoma.
January isn’t a particularly busy month for PDUFA dates for the U.S. Food and Drug Administration, with only two scheduled for the month. Here’s a look.
Collins, a former member of the Innate Immunotherapeutics Board of Directors, was indicted in 2018 and resigned his seat last year.
Posimir is a non-opioid being developed for post-surgical pain. It is designed to be injected into the surgical site, where it delivers bupivacaine for up to three days post-surgery.
For patients with diabetes, the new indication could become a key for survival as there is a well-established link between cardiovascular disease and type 2 diabetes.
Recipharm AB, through its directly wholly-owned subsidiary Recipharm Holdings Limited, published an offer document setting out the full terms and conditions of its recommended cash offer to acquire the entire issued and to be issued share capital of Consort Medical plc .
As the J.P. Morgan Healthcare Conference winds down for 2020, one of the big topics was the general lack of big deals. Still, there were some general trends and for today, some news.
Investigators found that the U.S. Food and Drug Administration is approving drugs faster than ever. Unfortunately, it appears that the agency is also approving those drugs on less data and weaker evidence.
The first of the Insys Therapeutics executives found guilty of violating the Racketeer Influenced and Corrupt Organizations Act in May 2019 has been sentenced.