Regeneron's blockbuster AMD biologic Eylea improved its ability to compete with future longer-acting VEGF inhibitors with a label supporting every dosing every 12 weeks; the company's less frequent regimen cleared FDA five days after receiving a complete response letter.
US FDA’s Aug. 17 approval of a supplemental biologic license application for Eylea (aflibercept) keeps Regeneron Pharmaceuticals Inc. well ahead of competitors developing treatments for wet age-related macular degeneration (AMD) that can be given less often, a significant advantage for products that are injected into the eye.
The sBLA for Eylea dosed every 12 weeks was approved just four days after the company said it received a...
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
