The US has plenty of new pharma legislation, Europe has plenty of worries about EMA's Brexit move, pharmacy benefit managers give plenty more scrutiny to which products earn a place on formulary. Policy Prescriptions rounds up recent regulatory news and trends reported by sister publication the Pink Sheet.
Conventional wisdom is that Washington DC, and the US Congress, experience an August doldrums each year. The Senate shook up that scenario Aug. 3, clearing not just the FDA user fee reauthorization package, but three other pieces of legislation impacting biopharma as well.
Most importantly, the user fee legislation, already passed by the House of Representatives, should head soon to the President's desk...
The world’s biggest pharmaceutical companies mostly saw growth in 2024 but 2025 promises to be more of a mixed bag with headwinds including losses of exclusivity, Medicare Part D redesign and challenges in the Chinese market.
The nod will help unlock a national market for the partners’ Dupert (fulzerasib) in which roughly 50,000 people are expected to be newly diagnosed with lung cancer harboring the KRAS G12C mutation in 2025. Meanwhile, two other homegrown rivals are also closing in on marketing clearances in China.
2030 sales forecasts for Novo’s obesity hope are an order of magnitude larger than its closest rival among 2025’s expected debutantes.
Tarsus Pharmaceuticals is putting more sales and marketing heft behind its novel eyelid disease therapy, Xdemvy, to capitalize on a solid start in a previously untapped market.
Lilly's first Phase III triplet win opens the door to a label expansion in BTK-pretreated CLL, with analysts suggesting Jaypica could attain blockbuster status. However, the window to capitalize may be brief as next-generation BTK degraders close in with head-to-head trials.
Lilly's first Phase III triplet win opens the door to a label expansion in BTK-pretreated CLL, with analysts suggesting Jaypica could attain blockbuster status. However, the window to capitalize may be brief as next-generation BTK degraders close in with head-to-head trials.
