When looking for a place to grow a life sciences business over the long term, sometimes the biggest location isn't ...

Recent proposed bills have targeted patents on branded drugs that may be asserted against potential generic or biosimilar manufacturers. The stated motive behind this trend is to make the lower-priced ...

"A version of this article was published first on Hyman, Phelps & McNamara’s FDA Law Blog. It is republished here with permission." In November, President-Elect Trump announced his pick of Robert ...

Local affiliates face significant time demands, often with very limited resources. These demands are perhaps most keenly felt in pharmacovigilance (PV). In many markets, requirements can include ...

The FDA’s Rare Pediatric Disease Priority Review Voucher (PRV) program — it’s a mouthful. And, if we don’t act now, it will sunset at the end of the year. I care. Why should you? Rare diseases impact ...

Everyone in the business is looking for breakthroughs, but only a select few win breakthrough therapy designation from the FDA. Under the guidance of Ira Gupta, M.D. and Shanthi Ganeshan, Ph.D, GSK ...

This past spring, Xaira Therapeutics launched with $1 billion in backing, a who's-who mashup of Silicon Valley and biopharma stars led by Marc Tessier-Lavigne in the C-suite, and a mission to develop ...

For all the drug commercialization successes he's played a leading hand in during his tenures at GSK, Genentech, and ImClone — Androderm, Augmentin, necitumumab, and Erbitux among them — Michael ...

In anticipation of ISCT 2024 in Vancouver, Canada, Dr. Bruce Levine is back on Cell & Gene: The Podcast to share information about the event as well as his expertise on the future of CAR-T therapy for ...