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62 articles about Biogen, Inc.
Biogen Inc. (NASDAQ: BIIB) today announced the appointment of Chuck Triano as Senior Vice President, Head of Investor Relations effective 10 April 2023.
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
Eisai Co., Ltd. and Biogen Inc. announced positive topline results from Eisai's large global Phase 3 confirmatory Clarity AD clinical trial of lecanemab, an investigational anti-amyloid beta protofibril antibody for the treatment of mild cognitive impairment due to Alzheimer's disease and mild AD with confirmed presence of amyloid pathology in the brain.
Sage Therapeutics and Biogen Announce the Phase 3 CORAL Study Met its Primary and Key Secondary Endpoints
Sage Therapeutics, Inc. (Nasdaq: SAGE), and Biogen Inc. (Nasdaq: BIIB) today announced the CORAL Study in people with major depressive disorder (MDD) met the trial objectives.
Biogen Reaches Agreement with Samsung Biologics to Sell Equity Stake in Their Biosimilar Joint Venture for up to $2.3 billion
Biogen Inc. (Nasdaq: BIIB) today announced that they have entered into an agreement whereby Samsung Biologics will acquire Biogen’s equity stake in the Samsung Bioepis joint venture for an aggregate consideration of up to USD $2.3 billion.
Biogen Inc. (Nasdaq: BIIB) and Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today announced that Biogen exercised its option to obtain from Ionis a worldwide, exclusive, royalty-bearing license to develop and commercialize BIIB115/ION306.
Update on Regulatory Submission for Aducanumab in the European UnionBiogen to seek re-examination following CHMP negative opinion for aducanumab
Biogen Inc. (Nasdaq: BIIB) and Eisai Co., Ltd. (Tokyo, Japan) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a negative opinion on the Marketing Authorization Application (MAA) for aducanumab.
Sage Therapeutics and Biogen Announce Positive, One-Year Zuranolone 50 mg Data in the Ongoing Open-Label SHORELINE Study in Patients with MDD
In the zuranolone 50 mg cohort, the majority of patients who responded to an initial 14-day course received only one two-week course of treatment during the study and nearly 80% received only one or two treatment courses in total.
Biogen Inc. today announced positive topline results from its Phase 2 CONVEY study of vixotrigine (BIIB074), a non-opioid investigational oral pain drug being evaluated for the treatment of small fiber neuropathy (SFN).
Biogen Plans to Initiate Phase 4 Study Evaluating Benefit of SPINRAZA® (nusinersen) in Patients Treated with Zolgensma® (onasemnogene abeparvovec)
In the long-term follow-up study of Zolgensma ® and real-world experience, it has been reported that some patients previously treated with gene therapy have been treated with SPINRAZA 1,2,3 The RESPOND study aims to evaluate the efficacy and safety of SPINRAZA in patients with a suboptimal clinical response to Zolgensma Biogen continues to advance research in spinal muscular atrophy to address the needs of the community and provide additional data to inform treatment decisions CAMBRIDGE,
Biogen, Broad Institute of MIT and Harvard, Partners HealthCare Launch Consortium to Build and Share a COVID-19 Biobank
Biogen employees, family members, and other close contacts can contribute blood samples and medical data to aid efforts to rapidly understand and overcome COVID-19 Biobank to provide scientists with access to a large collection of biological and medical data to advance knowledge and search for potential vaccines and treatments The consortium includes Brigham and Women’s Hospital and Massachusetts General Hospital, and will be overseen by a steering committee representing the different in
Biogen and Alkermes Announce FDA Approval of VUMERITY™ (diroximel fumarate) for Multiple Sclerosis– VUMERITY, a New Oral Treatment Option for Relapsing Forms of MS, Offers a Combination of Well-Characterized Efficacy, Safety and Tolerability –
Biogen Inc. (Nasdaq: BIIB) and Alkermes plc (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA) approved VUMERITY™ (diroximel fumarate), a novel oral fumarate with a distinct chemical structure, for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease
Biogen and Eisai to Discontinue Phase 3 ENGAGE and EMERGE Trials of aducanumab in Alzheimer's Disease
Independent data monitoring committee advises aducanumab unlikely to meet primary endpoints, leading to decision to discontinue the trials
Perhaps the last big hope for a successful Alzheimer’s drug just died. Biogen and its collaboration partner, Eisai, announced they were discontinuing the global Phase III clinical trials of aducanumab in patients with mild cognitive impairment from Alzheimer’s.
Fujifilm To Acquire Large-Scale Biologics Manufacturing Site From Biogen To Accelerate Growth Of Its Bio CDMO Business
FUJIFILM Corporation announced that it has entered into an agreement*1 to acquire Biogen Manufacturing ApS, a large-scale biologics manufacturing site located in Hillerød near Copenhagen, Denmark from Biogen for approximately US$890 million*2 in cash.
Alkermes and Biogen Announce U.S. Food and Drug Administration Acceptance of Diroximel Fumarate New Drug Application for Multiple Sclerosis
If approved, Biogen intends to market diroximel fumarate under the brand name VUMERITY™, which has been conditionally accepted by the FDA and will be confirmed upon approval.
Biogen and Skyhawk Therapeutics Announce Agreement to Develop Novel Small Molecule RNA Splicing Modifiers for Neurological Disease Targets
Biogen made a one-time upfront $74 million payment to Skyhawk for research services and an exclusive license to therapeutic candidates for multiple sclerosis, spinal muscular atrophy and other neurological diseases to be developed using Skyhawk's SkySTAR™ platform
Alkermes and Biogen Announce Submission of a New Drug Application to U.S. Food and Drug Administration for Diroximel Fumarate in Multiple Sclerosis
If approved, Biogen intends to market diroximel fumarate under the brand name VUMERITY™.
Biogen Exercises Option with Ionis to Develop and Commercialize Investigational Treatment BIIB067 for a Subtype of Familial Amyotrophic Lateral Sclerosis (ALS) Based on Positive Phase 1 Data
Positive interim analysis demonstrated proof-of-biology and proof-of-concept for BIIB067
Biogen, Inc. Second Quarter 2014 Revenues Increase 40% To $2.4 Billion; Company Raises Financial Guidance For The Year