BioSpace

The company was expecting a decision from the FDA by Sept. 28 for its oral drug tolebrutinib, but an update to the drug’s application package convinced the agency to take more time to review. https://hubs.li/Q03Kkbhl0

The acquisition of breakout obesity star Metsera should pump new life into Pfizer’s portfolio, which over the last two years has suffered from three discontinued assets. https://hubs.li/Q03KjQxT0

In an interview with German-language outlet Neue Zuercher Zeitung, Novartis CEO Vas Narasimhan said the company is exploring ways to remove or minimize the drug price gap between the U.S. and its other markets in similarly developed countries. #drugpricing #pharma #biospace https://hubs.li/Q03KhhFc0

For the last two years, Keytruda has reigned as the world’s top-selling drug—a distinction under threat with key patent protections expiring in 2028. #cancertreatment #biospace https://hubs.li/Q03KhhLC0

MapLight Therapeutics, Inc., the second biotech to launch a Nasdaq bid this month, is a neuro-focused company advancing treatments for Alzheimer’s disease psychosis and schizophrenia. #IPO #alzheimers #schizophrenia #biospace https://hubs.li/Q03KhdDG0

Subscribe to our GenePool newsletter to get top headlines and the most important breaking stories in biopharma. Expect us in your inbox Monday to Friday. Subscribe today: https://hubs.li/Q03DHbv80 #newsletter #biopharma #news #subscribe #biospace

Building and scaling biopharma workforces can go beyond recruiting permanent employees to include fractional workers and consultants. Eric Fink, Slone Partners' co-CEO and managing partner, discusses how these blended workforces operate, highlighting the strategic benefits. #biopharma #workforce #biospace https://hubs.ly/Q03KhLY-0

The FDA’s proposed Rare Disease Evidence Principles review process is a starting point for getting rare disease therapies across the finish line, but industry leaders say there are more concrete steps the regulator could take to help patients. #rarediseases #FDA #regulatory #biospace https://hubs.li/Q03KhdMJ0

With AbbVie's $1.2 billion acquisition of Gilgamesh Pharmaceuticals’ lead depression drug, the psychedelic therapeutics space has soundly rebounded from Lykos’ rejection last year. There are now seven programs in Phase III trials across the sector, with multiple companies vying for that first approval. #psychedelics #depression #biospace https://hubs.ly/Q03KhK-L0

A decade-long journey has come to an end for Stealth BioTherapeutics and the Barth syndrome community with the first-ever treatment for this uncommon mitochondrial disease. CEO Reenie McCarthy called it a “pivotal victory” that “offers hope for expedited regulatory attention to other ultra-rare diseases.” #rarediseases #FDA #biospace https://hubs.li/Q03Khcy30