Eisai Bets On Accelerated Approval For Biogen-Partnered Lecanemab
Filing Before Pivotal Data Beats Lilly’s Pre-Phase III Submission
Following Biogen’s lead with Aduhelm, the first disease-modifying Alzheimer’s therapy approved in the US, Eisai began a rolling BLA submission for lecanemab (BAN2401) ahead of next year’s Phase III results.
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In an attempt to show Biogen has more than its troubled Alzheimer’s drug Aduhelm to drive revenue growth, the company’s R&D Day highlighted several programs from its portfolio of 33 clinical-stage assets.
Keeping Track: Breakthroughs Of Summer Break Ground In Psychiatry, Cancer (Especially Nasopharygeal Cancer) And Vaccines
US FDA’s marquee expedited review program added 15 new breakthrough therapy designations between June and August.
Roche unveiled a strong Q2 performance driven by new medicines and continued strong growth from its diagnostics division but analysts were most keen for clues on plans for gantenerumab, now in Phase III studies for Alzheimer’s disease.