BioPharma Dive

22 hours ago | biopharmadive.com | Jacob Bell

Connecticut-based Biohaven has been developing what it hopes will be the first medicine for a group of rare, nerve-destroying diseases. The company ran a couple late-stage clinical trials, submitted an approval application to the Food and Drug Administration, and expected a verdict sometime before the end of September.

2 days ago | biopharmadive.com | Delilah Alvarado

The women’s health field has a long way to go addressing persistent deficits in research and treatment. Common conditions that affect women like endometriosis and polycystic ovarian syndrome remain misunderstood, while maternal mortality in the U.S. than in similarly wealthy countries. Yet there are green shoots. Startups focused on women’s health drew a record amount of venture funding in 2024, extending a run of recent momentum.

2 days ago | biopharmadive.com | Jonathan Gardner

President Donald Trump’s declaration Monday that the Department of Health and Human Services will pursue a plan to “equalize” drug prices with other countries both seeks to fulfill a campaign promise and fits with the “America first” theme of his second term. The path forward is uncertain, however.

2 days ago | biopharmadive.com | Jacob Bell

The Belgium-based drugmaker Galapagos is considering reversing course on plans to split into two biotechnology companies. In an announcement Tuesday, Galapagos said its board of directors decided to re-evaluate the separation because of “regulatory and market developments.” The company is now exploring “all strategic alternatives for its existing businesses” and, moving forward, the focus will be to direct as many resources as possible at “transformative” business development deals.

3 days ago | biopharmadive.com | Delilah Alvarado

Safety concerns have spurred the Food and Drug Administration and Centers for Disease Control and Prevention to recommend suspending use of Valneva’s chikungunya vaccine in people at least 60 years of age. The recommendation announced Monday comes days after the European Medicines Agency temporarily suspended use of the vaccine, known as Ixchiq, in those over 65 pending an investigation. A committee advising the CDC previously suggested a precaution for use in a similar age group.