Mari Serebrov

That didn't take long. Just days after the U.S. CMS finalized a rule to test the new GLOBE Model, an alternative rebate formula for certain Medicare Part B drugs, the Pharmaceutical Research and Manufacturers of America (PhRMA) filed a complaint in federal court to stop the rule on the grounds that it's unlawful and exceeds CMS' statutory authority.

Several initiatives the U.S. Department of Health and Human Services (HHS) announced Oct. 8 continue to shift the government's vaccine focus from disease prevention to vaccine harm. Strengthening “how the federal government identifies, documents, investigates, and responds to health problems reported following vaccination” is intended to improve patient care and generate “better evidence about potential vaccine-related injuries,” HHS said.

Although only two of the 18 executive orders (EOs) U.S. President Donald Trump signed in the third quarter directly impact the biopharma and med-tech space, one of them has continued to court controversy as the Senate considers the nomination of Heidi Overton as the next FDA commissioner.

Recognizing the unique challenges of developing and evaluating drugs to treat rare diseases, the U.S. FDA launched the Rare Disease Framework Initiative Oct. 14 to develop an optimized, fit-for-purpose framework that considers the nuances of each disease, patient needs, product type and the evidence that can be realistically generated in small patient populations.

Since his May 2022 release from prison on a securities fraud conviction, Martin Shkreli has been violating a U.S. federal court order by publicly

Just in time for the flu season, Sanofi SA has reached an agreement to resolve the EU Commission's preliminary concerns about the vaccine maker's

For nearly three decades, the U.S. NIH has had the Office of Research on Women's Health, which coordinates and supports research on the lifespan health of women. A new executive order, signed by the president Oct. 19, will augment that effort with a new women's health division within the NIH.

Although a mediated settlement is already on the table awaiting court approval, the U.S. Court of Appeals for the Fifth Circuit breathed new life into Cassava Sciences Inc.'s fight to stave off a shareholder class action alleging the company, now known as Filana Therapeutics Inc., and its executives defrauded investors by misrepresenting the success of simufilam, an experimental Alzheimer's drug.

As part of the U.S. National Alzheimer's Project Act, the FDA launched the Neuroscience Advancement and Innovation Nexus Oct. 22 to advance the science, tools and regulatory approaches needed to support the development of medical products for conditions affecting the brain and nervous system.

It's been more than four years since the U.S. FTC, at congressional insistence, opened its investigation into pharmacy benefit manager (PBM) practices. The agency needs to wrap it up and release a final public report, along with recommendations to Congress as soon as practicable, according to bipartisan leadership of the Senate Judiciary and Commerce committees.