Biogen

Samsung Bioepis and Biogen Announce EMA Filling Acceptance of SB11 (biosimilar, Lucentis)

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Shots: EMA has accepted to review the Marketing Authorisation Application for SB11, a proposed biosimilar referencing Lucentis (ranibizumab). If approved, SB11 will join a growing number of biosimilars developed by Samsung Bioepis and commercialized by Biogen In Nov 2019, Samsung Bioepis announced that it entered… Read More »Samsung Bioepis and Biogen Announce EMA Filling Acceptance of SB11 (biosimilar, Lucentis)

Biogen Signs an Agreement with Denali on LRRK2 Program for Parkinson’s Disease Worth ~$2.125B

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Shots: Denali to receive $560M up front, $465M as equity investment at a price of $34.94/ share, representing 11.2% of Denali’s Pro-forma outstanding stock along with $1.125B as milestones. The two companies will codevelop Denali’s LRRK2 inhibitor for PD and co-commercialize it in the US… Read More »Biogen Signs an Agreement with Denali on LRRK2 Program for Parkinson’s Disease Worth ~$2.125B

Biogen plans trial of Spinraza in patients not responding to SMA gene therapy

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Biogen is planning to trial its Spinraza spinal muscular atrophy (SMA) drug in patients who have not responded properly to Novartis’ gene therapy Zolgensma, combining the two ultra-expensive therapies to treat the rare muscle-wasting disease. In the US, a single shot of Zolgensma (onasemnogene abeparvovec)… Read More »Biogen plans trial of Spinraza in patients not responding to SMA gene therapy

Biogen, Eisai complete submission of controversial Alzheimer’s drug. The ball is in FDA’s court now.

The FDA has 60 days to decide whether or not to accept the application. An analyst wrote that the agency accepting it with a priority or standard review may signal whether the agency is seriously considering approval or has continued reservations about the amyloid beta-targeting… Read More »Biogen, Eisai complete submission of controversial Alzheimer’s drug. The ball is in FDA’s court now.