Where are legislative trends pointing on biopharmaceutical patents? Sona De, a partner at Sidley, reviews existing proposals ...

Local market pharmacovigilance (PV) requirements can be daunting to manage successfully. Experts at PharmaLex provide best ...

Make America Healthy Again” is coming to Washington. Jennifer D. Newberger and Jeffrey N. Gibbs at Hyman, Phelps, & McNamara, ...

The FDA’s Rare Pediatric Disease Priority Review Voucher (PRV) program is set to expire on December 20, 2024, if the U.S.

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 ...