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May 9, 2022

EISAI COMPLETES ROLLING SUBMISSION TO THE U.S. FDA FOR BIOLOGICS LICENSE APPLICATION OF LECANEMAB FOR EARLY ALZHEIMER’S DISEASE  UNDER THE ACCELERATED APPROVAL PATHWAY

TOKYO and CAMBRIDGE, Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Michel Vounatsos, "Biogen") announced today that Eisai has completed the rolling submission to the U.S.

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May 9, 2022

EISAI COMPLETES ROLLING SUBMISSION TO THE U.S. FDA FOR BIOLOGICS LICENSE APPLICATION OF LECANEMAB FOR EARLY ALZHEIMER’S DISEASE  UNDER THE ACCELERATED APPROVAL PATHWAY

TOKYO and CAMBRIDGE, Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Michel Vounatsos, "Biogen") announced today that Eisai has completed the rolling submission to the U.S.

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May 5, 2022

Biogen and MedRhythms to Develop and Commercialize a Prescription Digital Therapeutic Targeting the Treatment of Gait Deficits in Multiple Sclerosis

The investigational prescription digital therapeutic uses a combination of sensors, software, and music based on Rhythmic Auditory Stimulation (RAS) MedRhythms to receive a $3 million upfront payment as part of the agreement and is eligible to receive potential development and commercial milestone

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May 2, 2022

Sage Therapeutics and Biogen Initiate Rolling Submission of New Drug Application (NDA) to U.S. Food and Drug Administration for Zuranolone for the Potential Treatment of Major Depressive Disorder (MDD)

The companies expect to complete submission of the NDA for treatment of MDD in the second half of 2022; associated filing for postpartum depression anticipated in the first half of 2023 CAMBRIDGE, Mass. – May 2, 2022 – Sage Therapeutics, Inc. (Nasdaq: SAGE) and Biogen Inc.

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April 22, 2022

Update on Regulatory Submission for Aducanumab in the European Union

Biogen Inc. (Nasdaq: BIIB) has notified the European Medicines Agency (EMA) of its decision to withdraw its Marketing Authorization Application (MAA) for aducanumab for the treatment of the early stages of Alzheimer’s disease. The company withdrew its application following interactions with EMA’s

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April 20, 2022

Biogen Completes Sale of Equity Stake in Biosimilar Joint Venture to Samsung Biologics for $2.3 Billion

Biogen has completed the sale of the company’s equity stake in the Samsung Bioepis joint venture to Samsung Biologics for a total consideration of up to USD$2.3 billion, of which $1 billion in cash was due at closing and has been received. The terms of the agreement were first announced on January

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April 7, 2022

Biogen’s Statement on the Final National Coverage Determination for Amyloid-Beta Targeting Therapies for the Treatment of Alzheimer’s Disease

This unprecedented CMS decision effectively denies all Medicare beneficiaries access to ADUHELM® (aducanumab-avwa), the first and only FDA-approved therapy in a new class of Alzheimer’s drugs. It may also limit coverage for any future approved treatment in the class.

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April 5, 2022

Biogen to Report First Quarter 2022 Financial Results May 3, 2022

Cambridge, Mass.— Biogen Inc. (Nasdaq:BIIB) today announced it will report first quarter 2022 financial results Tuesday, May 3, 2022, before the financial markets open.  Following the release of the financials, the Company will host a live webcast with Biogen management at 8:00 a.m. ET.

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April 4, 2022

New Data at AAN 2022 Highlight Real-World Evidence from Biogen’s MS Portfolio and Emerging Research on Disease Progression

Data from NOVA study further support the efficacy and safety of natalizumab IV when administered every six weeks as compared to the approved every four-week dosing Additional real-world data affirm high rates of persistence and adherence for VUMERITY ® (diroximel fumarate) Early research

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March 30, 2022

Biogen Submits Final Protocol for ADUHELM® (aducanumab-avwa) Phase 4 ENVISION Trial to FDA

Confirmatory trial’s completion is expected in an accelerated timeline of four years with patient screening to start in May Multiple strategies in place to enroll patients that are representative of diverse American population CAMBRIDGE, Mass., March 30, 2022 (GLOBE NEWSWIRE) -- Biogen Inc.