The FDA is not approving two biosimilars from Teva and Celltrion over concerns about the latter's facility, leading to more speculation that approval of the Israeli firm's potential migraine blockbuster, manufactured at the same plant, may be delayed.
The nail-biting at Teva Pharmaceutical Industries Ltd. over whether its investigational migraine drug fremanezumab will get US approval by the summer is going to continue for a while as the manufacturing problems at partner Celltrion Inc.'s facility where the active ingredient is made have come to a head.
The trouble started in January when the FDA issued a warning letter to Celltrion citing an extensive number of GMP...
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.
