FDA cleared Mylan's generic version of Copaxone 40mg even after management warned investors not to expect action until 2018. Mylan said it will launch "imminently, but Teva said a launch ahead of the pending appeals case would be "at risk."
Mylan NV has won FDA approval of the first generic version of a 40mg dose of Teva Pharmaceutical Industries Ltd.'s Copaxone (glatiramer) for multiple sclerosis, setting Mylan up for a potentially lucrative commercial opportunity while adding to Teva's mounting challenges.
The news, announced after market close Oct. 3, took investors from both companies by surprise since Mylan's management recently warned...
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.
