Fierce Pharma

By channeling proceeds from its commercial products into late-stage oncology and rare disease programs, Moderna believes it can “set the stage for additional growth in 2027 and 2028." https://lnkd.in/gZWJkdJy

The single reported patient death “appears to be related to Adzynma,” the FDA said in a Nov. 21 safety communication.  https://lnkd.in/gZi7f_iz

After months of back-and-and forth with the FDA and a third-party manufacturer, Regeneron has secured two long-awaited approvals for Eylea HD, gaining a new indication and a more flexible dosing option for the eye disease drug. https://lnkd.in/gv938fz9

Bayer's Hyrnuo won an accelerated approval based on its tumor response showing in a phase 1/2 study. https://lnkd.in/eT3n-wac

Announcing Our 2025 Fierce Life Sciences Innovation Award Winners https://loom.ly/iF7brUk Today’s life sciences landscape extends far beyond the wet lab. Breakthroughs in AI, gene editing, nanotechnology, and data science are accelerating discovery, enabling curative therapies, and opening entirely new therapeutic frontiers. This year’s winners reflect just how powerfully science and technology now intersect. They’re using advanced AI models to speed drug discovery, building manufacturing capabilities for n-of-1 therapies, and applying large-scale quantitative models to de-risk R&D—even for complex diseases like Alzheimer’s and Parkinson’s. Evaluated across effectiveness, technical innovation, competitive advantage, financial impact, and true originality, these organizations rose to the top from hundreds of applications. Click here to view the 2025 winners: https://loom.ly/iF7brUk #FierceLSInnovationAwards #FierceInnovationAwards

Agentic AI represents a paradigm shift in how we approach the life sciences workforce. By integrating this advanced technology, we can enhance productivity, streamline processes, and drive innovation. Find out more: https://bit.ly/3M0eEI4 Cognizant #Sponsored

Amid uncertainty for its vaccine division, CSL is growing the footprint of its bread-and-butter plasma therapies business by pledging a capital investment of about $1.5 billion for U.S.-based manufacturing. https://lnkd.in/gUpfnMwq

By souping up a Saratoga Springs facility—which sits on a more than 1-million-square-foot property—Regeneron is poised to nearly double its existing production capacity in New York. https://lnkd.in/gFiWWQka

The FDA has officially limited the label of Sarepta Therapeutics’ Elevidys, removed the indication for non-ambulatory patients with Duchenne muscular dystrophy. https://lnkd.in/gD6s49ab

This year’s Fiercest Women in Life Sciences list highlights leaders who are rewriting the rules of biotech and pharma. From boardrooms to labs, these women are advancing innovation, driving transformation and mentoring the next generation. Dive into their stories: https://lnkd.in/g7m_deEm