The FDA’s proposal to offer 50% off application fees for drugs with early-stage trials conducted in the U.S. is unlikely to achieve the intended result. What biotechs really want is speed.
For PDUFA VIII, the most valuable incentive may be time Read More »
Rep. Frank Pallone sent oversight letters to six arbiters requesting information on how they decide awards, how they’re paid and more. His office is also in talks with other arbiters, but they’ve been more responsive, a staffer said.
The insurer is still working on strategies to ensure its MA markets remain as profitable as possible, but it’s confident in its posture heading into 2027 open enrollment, Wayne DeVeydt said Wednesday.
It’s the second wave of layoffs at the nonprofit this year. Trinity said financial pressures and increasingly complex technology requirements were driving it to outsource some tech roles.
The medtech industry is awaiting FDA guidance on generative AI. The agency has sought feedback in advisory meetings and a discussion paper as the technology becomes more prevalent.
4 questions about the FDA’s approach to generative AI Read More »
Watch this discussion on how GLP-1 drugs for obesity are changing the shape of U.S. healthcare. From direct-to-consumer portals to pharmacy deals, how these drugs reach patients is changing—and leading to debates over pricing and coverage. Learn how your company can be both patient-forward while also maximizing revenue in this unique environment.
Webinar: The Massive Scale of GLP-1s: Evolving Health, Healthcare and Markets Read More »
The company is investing billions of dollars to construct a European biosimilar hub capable of supporting the rapid expansion of its portfolio.
Bristol Myers Squibb is positioning arlo-cel for quadruple-class exposed patients, which could help reduce competition with an upcoming multiple myeloma CAR T therapy from Gilead Sciences, according to BMO Capital Markets.
BMS clinches pivotal win for myeloma CAR T in ‘key derisking event’ Read More »
The decision to promote Michael Davis and Karim Mikhail from acting to permanent division heads comes as the FDA awaits the potential confirmation of Heidi Overton, President Donald Trump’s nominee for commissioner.
Acting CBER, CDER heads become permanent as FDA works to restore stability Read More »
September has been a rough month already for Novo Nordisk, which canned two more late-stage trials of its embattled IL-6 inhibitor, and Novartis, which took Phase 3 hits in both cardiovascular and muscular dystrophy indications; Ultragenyx’s big bet in Angelman syndrome failed to yield benefit in Phase 3 but Ionis’ Pharmaceuticals nabbed the first targeted
