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
Company will present at Biotech Showcase™ 2020 on Monday, 01/13/20 at 11:15am PST in San Francisco, CA
AstraZeneca and Merck are closing out 2019 on a high note with another approval for its PARP inhibitor Lynparza.
Over the course of 2019, there have been numerous reports that show the increasing price of the medication is keeping it out of reach of patients. Some lawmakers are placing the blame squarely on the shoulders of drugmakers.
The Shenzhen Nanshan District People’s Court sentenced He today to three years in prison and a fine of 3 million yuan ($430,000 U.S.). Two other medical researchers, Zhang Renli and Qin Jinzhou, worked with He and were also sentenced.
The clinical trials the approval is based on suggested the drug was effective for treating primary insomnia but may also be effective for insomnia associated with other diseases, such as depression.
Specifically, it was approved for adults with unresectable or metastatic HER2-positive breast cancer who have had two or more previous anti-HER2-based treatments in the metastatic setting.
The U.S. Government is increasing the measures it is taking to counter what it sees as a growing threat to scientific intellectual property from China.
Moving into the holidays and the fast-approaching end of the year, the U.S. Food and Drug Administration (FDA) got busy wrapping up a number of to-do items. Here’s a look.
At the Drug Development Unit at The Institute of Cancer Research, London, and The Royal Marsden NHS Foundation Trust in London, the first patient in Phoenix’s first in human “ACTivate Trial” has received ACT® in combination with chemotherapy for treatment of hepatic metastases associated with colorectal and pancreatic cancer.
Reston Hospital has received verification as a Level II Trauma Center by the American College of Surgeons for a period of three years through the year 2022.