Facing an appeal on a favorable US district court decision, Mylan has opted to launch the first generic Tecfidera in the US “at risk,” after obtaining FDA approval and seeing Biogen’s bid for injunctive relief shot down earlier this month.
Mylan has decided to introduce “at risk” the first generic version of Biogen, Inc.’s $3.3bn Tecfidera (dimethyl fumarate) in the US following Food and Drug Administration approval for its abbreviated new drug application, with litigation still pending over the last remaining Tecfidera patent listed in the agency’s Orange Book.
Market entry was confirmed by Mylan on 19 August, hours after the FDA’s database of approved drugs showed the company...
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.
As clinical trials grow more complex, execution pressures are changing where and how evidence is collected.
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.
