President Donald Trump put the biopharma industry on its back foot earlier this month with his executive order on international reference prices. While many unknowns remained at the time of the May 12 ...

Michael Ellenberger, Aydin Harston Ph.D. On October 29, 2025, the U.S. Food and Drug Administration (FDA), in coordination with the Department of Health and Human Services (HHS) and the Centers for ...

On March 11, 2024, the White House released President Biden’s FY 2025 Department of Health and Human Services (HHS) Budget in Brief, which outlines $130.7 billion in discretionary funding for HHS.

Sen. Pat Roberts (R-KS), and Reps. Joe Barton (R-TX) and Anna Eshoo (D-CA) as well as 52 other representatives and nine senators sent letters to Tom Price, Health & Human Services secretary, and Seema ...

There might just be a silver lining for Johnson & Johnson in the FDA's recent approval of Amgen’s Stelara biosimilar. That’s because the coming entry of a cheaper copycat presents J&J with an ...

Ed’s stories explore prescription drug pricing, affordability and access, as well issues surrounding patents, litigation, and legislation. He is also the author of the morning Pharmalittle newsletter ...

The Association for Accessible Medicines has submitted comments to the U.S. Department of Health and Human Services and the Federal Trade Commission in response to a request for Information to better ...

The Inflation Reduction Act (IRA) effectively imposed price controls on a portion of the pharmaceutical market. Worse, by design, the reach of these price controls will expand every year. The intended ...

Prescription drug pricing, generic and biosimilar competition, and access to over-the-counter (OTC) hearing aids are among the targets of a sweeping executive order signed by President Joe Biden on ...

Please provide your email address to receive an email when new articles are posted on . The FDA issued draft guidance that would streamline testing of biosimilars. A separate plan would eliminate ...

Build Back Better Act Drug Pricing Reform ASP+8 for biosimilars Domestic Manufacturing Medicare implications on biosimilars Appropriations pertaining to FDA inspections and American Made preferences ...