Biogen News Releases and Company Statements
Media Contacts
US Media Relations
Public.Affairs@biogen.com
Europe Media Relations
PublicAffairs.EU@biogen.com
Japan Media Relations
Japan-PA@biogen.com
December 9, 2022
News Release
FDA Accepts Biogen Biologics License Application for BIIB800, A Biosimilar Candidate Referencing ACTEMRA® (tocilizumab)
December 6, 2022
News Release
Biogen and Sage Therapeutics Complete Rolling Submission of New Drug Application for Zuranolone in the Treatment of Major Depressive Disorder and Postpartum Depression
December 5, 2022
News Release
European Medicines Agency Accepts Tofersen Marketing Authorization Application to Treat Rare, Genetic Form of ALS
November 29, 2022
News Release
Eisai Presents Full Results of Lecanemab Phase 3 Confirmatory Clarity Ad Study for Early Alzheimer’s Disease At Clinical Trials On Alzheimer’s Disease (Ctad) Conference
November 29, 2022
News Release
Eleven Experts From Leading Medical Institutions And Eight Experts From Eisai* Publish Full Results Of Lecanemab Phase 3 Confirmatory Clarity Ad Study For Early Alzheimer’s Disease In The New England Journal Of Medicine
November 22, 2022
News Release
Sage Therapeutics and Biogen to Host Investor Webcast on December 6, 2022 to Discuss Potential Commercialization Plans for Zuranolone
November 17, 2022
News Release
Biogen to Participate in the 5th Annual Evercore ISI HealthCONx Conference
November 10, 2022
News Release
Biogen Names Christopher Viehbacher President and Chief Executive Officer
October 26, 2022
News Release
Biogen Data at ECTRIMS 2022 Highlight Innovation in Digital Health Focused on Advancing Treatment and Personalized Care of People Living with MS
October 26, 2022
News Release
New Data at ECTRIMS 2022 Highlight Biogen’s Commitment to Advancing Individualized Disease Management for People Living with MS
October 17, 2022
News Release
Biogen Announces FDA’s 3-Month Extension of Review Period for the New Drug Application for Tofersen
October 17, 2022
News Release
Biogen and Sage Therapeutics Present Further Analyses from Phase 3 SKYLARK Study of Zuranolone in Postpartum Depression at the European College of Neuropsychopharmacology (ECNP) Congress
October 11, 2022
News Release
BIOGEN TO REPORT THIRD QUARTER 2022 FINANCIAL RESULTS OCTOBER 25, 2022
October 10, 2022
News Release
Biogen Announces First Patient Dosed in Pivotal Study of Litifilimab in Cutaneous Lupus Erythematosus, an Autoimmune Disease Affecting Skin
October 3, 2022
News Release
Biogen and Denali Therapeutics Announce Initiation of the Phase 3 LIGHTHOUSE Study in Parkinson’s Disease Associated with LRRK2 Pathogenic Mutations
September 30, 2022
News Release
Biogen Announced EMA Filing Acceptance of BIIB800, A Biosimilar Candidate Referencing RoACTEMRA® (tocilizumab)
September 27, 2022
News Release
LECANEMAB CONFIRMATORY PHASE 3 CLARITY AD STUDY MET PRIMARY ENDPOINT, SHOWING HIGHLY STATISTICALLY SIGNIFICANT REDUCTION OF CLINICAL DECLINE IN LARGE GLOBAL CLINICAL STUDY OF 1,795 PARTICIPANTS WITH EARLY ALZHEIMER’S DISEASE
September 21, 2022
News Release
The New England Journal of Medicine Publishes Pivotal Tofersen Data that Show Benefits in Rare, Genetic Form of ALS
September 20, 2022
Company Statements
STATEMENT: BIOGEN COMPLETES CORPORATE REAL ESTATE TRANSACTION TO ALIGN ITS CAMBRIDGE OFFICE SPACE FOOTPRINT WITH NEW WORKING ENVIRONMENT
September 19, 2022
News Release
Biogen and Sage Therapeutics Present New Analyses at Psych Congress Further Evaluating the Efficacy and Safety of Zuranolone
September 7, 2022
News Release
The New England Journal of Medicine Publishes Second Manuscript Reporting Positive Phase 2 Results for Biogen’s Litifilimab (BIIB059) in Lupus
August 31, 2022
News Release
Biogen to Participate in the Morgan Stanley 20th Annual Global Healthcare Conference
August 31, 2022
Company Statements
Statement on Alzheimer’s & Dementia® Journal Publication about Association between Reduction of Amyloid Beta and Slowing of Cognitive and Functional Decline in Alzheimer’s Disease
August 3, 2022
News Release
EISAI PRESENTS NEW FINDINGS ON LECANEMAB’S INVESTIGATIONAL SUBCUTANEOUS FORMULATION AND MODELING SIMULATION OF APOE4 GENOTYPE ON ARIA-E INCIDENCE AT THE ALZHEIMER’S ASSOCIATION INTERNATIONAL CONFERENCE (AAIC) 2022
July 28, 2022
News Release
The New England Journal of Medicine Publishes Positive Phase 2 Data on Litifilimab (BIIB059) in Cutaneous Lupus Erythematosus
July 26, 2022
News Release
FDA Accepts Biogen’s New Drug Application and Grants Priority Review of Tofersen for a Rare, Genetic Form of ALS
July 5, 2022
News Release
The U.S. FDA Accepts and Grants Priority Review for EISAI’s Biologics License Application of Lecanemab for Early Alzheimer’s Disease Under the Accelerated Approval Pathway
June 22, 2022
News Release
Biogen and Happify Health Collaborate to Support Multiple Sclerosis Patients on Digital Platform
June 21, 2022
News Release
European Patent Office Grants Patent Related to TECFIDERA® (Dimethyl Fumarate)
June 15, 2022
Company Statements
Biogen Appreciation Statement for Retiring Board Members Nancy Leaming and Brian Posner
June 15, 2022
News Release
New Data Presented at Cure SMA Reveal Residual Unmet Needs in Young SMA Patients Treated With Gene Therapy and Suggest Further Potential of Using SPINRAZA® (nusinersen)
June 14, 2022
News Release
The Biogen Foundation and Community Lab Celebrates 20 Years of Serving our Communities
June 6, 2022
News Release
Biogen and Alectos Therapeutics Announce License and Collaboration Agreement for AL01811, a Novel GBA2 Inhibitor for the Potential Treatment of Parkinson’s Disease
June 3, 2022
News Release
Biogen and Bio-Thera Solutions Present Positive Phase 3 Data for Tocilizumab Biosimilar Candidate at the Annual European Congress of Rheumatology (EULAR 2022)
June 3, 2022
News Release
New 12-Month Tofersen Data Presented at ENCALS Meeting Show Clinically Meaningful Benefit in People With SOD1-ALS
June 2, 2022
News Release
Biogen and Samsung Bioepis’ BYOOVIZ™ (ranibizumab-nuna) Launches in the United States
June 1, 2022
News Release
Sage Therapeutics and Biogen Announce that the Phase 3 SKYLARK Study of Zuranolone in Postpartum Depression Met its Primary and All Key Secondary Endpoints
May 31, 2022
News Release
Denali Therapeutics and Biogen Announce Initiation of Phase 2b Study of LRRK2 Inhibitor in Parkinson’s Disease
May 9, 2022
News Release
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
May 5, 2022
News Release
Biogen and MedRhythms to Develop and Commercialize a Prescription Digital Therapeutic Targeting the Treatment of Gait Deficits in Multiple Sclerosis
May 2, 2022
News Release
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)
April 29, 2022
Company Statements
Biogen Statement Regarding Updated ADUHELM® (aducanumab-avwa) Prescribing Information in US
April 28, 2022
Company Statements
Biogen To Offer Continuity of Care Plan for U.S. Patients Currently Treated with ADUHELM® (aducanumab-avwa)
April 22, 2022
Company Statements
Update on Regulatory Submission for Aducanumab in the European Union
April 20, 2022
News Release
Biogen Completes Sale of Equity Stake in Biosimilar Joint Venture to Samsung Biologics for $2.3 Billion
April 7, 2022
Company Statements
Biogen’s Statement on the Final National Coverage Determination for Amyloid-Beta Targeting Therapies for the Treatment of Alzheimer’s Disease
April 4, 2022
News Release
New Data at AAN 2022 Highlight Real-World Evidence from Biogen’s MS Portfolio and Emerging Research on Disease Progression
March 30, 2022
News Release
Biogen Submits Final Protocol for ADUHELM® (aducanumab-avwa) Phase 4 ENVISION Trial to FDA
March 28, 2022
Collaborations
Biogen and Ionis Announce Topline Phase 1 Study Results of Investigational Drug in C9orf72 Amyotrophic Lateral Sclerosis
March 21, 2022
News Release
Latest Findings on Lecanemab - Clinical Efficacy, Aria Rates, Biomarkers Relationship to Clinical Outcomes and Dosing Regimens - Presented at AD/PD™ 2022 Annual Meeting
March 18, 2022
News Release
Company Statements
The National Minority Quality Forum and Biogen Highlight Equitable Access to Research and Care in Real World Evidence White Paper
March 16, 2022
News Release
Biogen Announces Peer-Reviewed Publication of ADUHELM® Phase 3 EMERGE and ENGAGE Data in The Journal of Prevention of Alzheimer’s Disease
March 16, 2022
News Release
Long-Term Phase 3 Data Show ADUHELM® Continues to Reduce Underlying Pathologies of Alzheimer’s Disease in Patients Treated for More Than Two Years
March 14, 2022
News Release
Biogen and Eisai amend collaboration agreements on Alzheimer’s disease treatments
March 14, 2022
News Release
Biogen Announces New Updates Across its SMA Research Program at 2022 MDA Conference
March 11, 2022
News Release
Biogen to Present New Research at the International Conference on Alzheimer’s and Parkinson’s Diseases (AD/PD 2022)
March 4, 2022
News Release
EISAI INITIATES SUBMISSION OF APPLICATION DATA UNDER THE PRIOR ASSESSMENT CONSULTATION SYSTEM IN JAPAN WITH THE AIM OF OBTAINING EARLY APPROVAL FOR INVESTIGATIONAL ANTI-AMYLOID BETA PROTOFIBRIL ANTIBODY LECANEMAB
February 16, 2022
News Release
Sage Therapeutics and Biogen Announce the Phase 3 CORAL Study Met its Primary and Key Secondary Endpoints - Comparing Zuranolone 50 mg Co-initiated with Standard of Care Antidepressant vs. Standard of Care Co-initiated with Placebo in People with MDD
February 10, 2022
Company Statements
Biogen Submits Response to the Centers for Medicare and Medicaid Services (CMS) Proposed National Coverage Determination (NCD) for Anti-Amyloid Treatments in Alzheimer’s Disease
February 7, 2022
News Release
Biogen and Xbrane Announce Commercialization and License Agreement for Proposed Biosimilar Referencing CIMZIA® (Certolizumab pegol) with the Potential to Treat Rheumatoid Arthritis
February 1, 2022
News Release
Biogen Exercises Option to Participate in the Development and Commercialization of a Late-Stage Bispecific Antibody
January 31, 2022
News Release
Biogen Announces Nancy Leaming and Brian Posner to Retire from Board of Directors
January 27, 2022
News Release
Biogen Reaches Agreement with Samsung Biologics to Sell Equity Stake in Their Biosimilar Joint Venture for up to $2.3 billion
January 19, 2022
News Release
Biogen to Report Fourth Quarter and Full Year 2021 Financial Results February 3, 2022
January 11, 2022
News Release
Company Statements
Biogen’s Statement on the Draft National Coverage Determination (NCD) for Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease
January 4, 2022
News Release