Concerns that the extended-release oxycodone product poses the same potential for intravenous abuse as Endo’s withdrawn Opana ER drive FDA advisory committee recommendation against approval, laying the groundwork for a fourth complete response letter; FDA’s comparison of Remoxy to Opana during the meeting ‘borders on slanderous,’ PTI CEO Barbier tells Scrip, predicting sponsors will be dissuaded by the shifting regulatory goalposts for abuse-deterrent formulations.
Pain Therapeutics Inc. is standing on the verge of a regulatory dead-end for Remoxy (oxycodone extended-release) following a US FDA advisory committee’s negative review June 26, and the company's CEO warns that the "changing goalposts" might deter future development in the abuse-deterrent opioid space.
The committee’s 14-3 vote against approval suggests the long-acting opioid formulated with abuse-deterrent properties is headed for its fourth complete...
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.
Mounjaro, Eliquis, and Darzalex buck the Q1 trend to make gains
