Biogen

Biogen Signs a License and Commercialization Agreement with Bio-Thera for BAT1806 (biosimilar, tocilizumab) to Treat Moderate to Severe Rheumatoid Arthritis

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Shots: Bio-Thera to receive $30M up front following the achievement of P-III satisfactory results and is eligible for commercial milestones along with royalties. The transaction is expected to close in Q2’21 Biogen to get exclusive regulatory, manufacturing, and commercial rights of BAT1806 in all countries… Read More »Biogen Signs a License and Commercialization Agreement with Bio-Thera for BAT1806 (biosimilar, tocilizumab) to Treat Moderate to Severe Rheumatoid Arthritis

Biogen’s Tysabri (natalizumab, SC) Receives EC’s Marketing Authorization to Treat Relapsing-Remitting Multiple Sclerosis

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Shots: The EC’s approval is based on data from DELIVER and REFINE studies evaluating the efficacy, PK, and PD of Tysabri (300mg, SC, q4w) vs Tysabri (300mg, IV, q4w) in patients with RRMS The results demonstrated that the Tysabri (SC) in both studies showed clinical… Read More »Biogen’s Tysabri (natalizumab, SC) Receives EC’s Marketing Authorization to Treat Relapsing-Remitting Multiple Sclerosis

ViewPoints Interview: Biogen’s Wildon R. Farwell Shares Insight on Phase 4 RESPOND Study of Spinraza

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In an interview with PharmaShots, Wildon R. Farwell, M.D., MPH, Global Medical Head of Neuromuscular Diseases at Biogen shared his views on the P-IV RESPOND study that assesses the benefits of Spinraza in patients treated with Zolgensma. Shots: RESPOND is a two-year, open-label study to… Read More »ViewPoints Interview: Biogen’s Wildon R. Farwell Shares Insight on Phase 4 RESPOND Study of Spinraza

PharmaShots Weekly Snapshots (Jan 11 – 15, 2021)

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Novartis’ Ligelizumab (QGE031) Receives the US FDA’s Breakthrough Designation for Patients with Chronic Spontaneous Urticaria Published: Jan 15, 2020 | Tags: Novartis’, Ligelizumab (QGE031), Receives ,US FDA’s, Breakthrough Designation for Patients , Chronic Spontaneous Urticaria Philips Collaborates with Merck KGaA to Advance Personalized Fertility Treatment… Read More »PharmaShots Weekly Snapshots (Jan 11 – 15, 2021)

Biogen Signs a License Agreement with ViGeneron for Ophthalmic Gene Therapy Development

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Shots: ViGeneron to receive an up front and R&D funding for the mutually agreed workplan and will receive development, regulatory and commercial milestone payments along with royalties on sales of products arising from the collaborations ViGeneron will optimize and validate in vitro therapeutic candidates for… Read More »Biogen Signs a License Agreement with ViGeneron for Ophthalmic Gene Therapy Development

Biogen’s Plegridy (peginterferon beta-1a, IM) Receives EC’s Approval for Relapsing-Remitting MS

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Shots: The approval is based on data assessing bioequivalence and AEs associated with IM administration vs SC administration of Plegridy in healthy volunteers Result: The data showed that participants receiving therapy through IM experienced fewer injection site reactions (14.4 vs 32.1 %), safety profiles were… Read More »Biogen’s Plegridy (peginterferon beta-1a, IM) Receives EC’s Approval for Relapsing-Remitting MS

Biogen Reports NDA Submission of Aducanumab (BIIB037) to the MHLW for Alzheimer’s Disease

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Shots: The submission is based on P-lll EMERGE and ENGAGE study assessing aducanumab vs PBO in patients with AD. The studies evaluate the efficacy of monthly doses of aducanumab in reducing cognitive and functional impairment The secondary objectives of the study were to assess the… Read More »Biogen Reports NDA Submission of Aducanumab (BIIB037) to the MHLW for Alzheimer’s Disease

Samsung Bioepis and Biogen Announces FDA Filing Acceptance of Lucentis’ Biosimilar, SB11 for Retinal Vascular Disorders

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Shots: EMA accepted the review of MAA for SB11 in Oct 2020. If approved, SB11 will add to the biosimilars portfolio developed by Samsung Bioepis and commercialized by Biogen, including three widely prescribed anti-TNF biosimilars in EU: BENEPALI, IMRALDI, and FLIXABI In Nov 2019, Samsung… Read More »Samsung Bioepis and Biogen Announces FDA Filing Acceptance of Lucentis’ Biosimilar, SB11 for Retinal Vascular Disorders

The US FDA’s Advisory Panel Slams Biogen’s Aducanumab for Alzheimer’s Disease

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Shots: The advisory committee voted 1-8, with 2 members voting uncertain that EMERGE study (without regard for ENGAGE study) provides strong evidence, supporting the effectiveness of aducanumab as a treatment for AD. The committee also voted 0-7 with 4 members voting uncertain that PRIME study… Read More »The US FDA’s Advisory Panel Slams Biogen’s Aducanumab for Alzheimer’s Disease

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.