Dapirolizumab pegol (DZP) Phase 3 study presentations in SLE to show efficacy results across multiple clinical endpoints, including low disease activity/remission, flares, fatigue, joint pain and quality of life Presentation of preclinical study of DZP showing minimal to no human placental transfer CAMBRIDGE, Mass., Oct. 22, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced upcoming presentations from... Read More

TOKYO and CAMBRIDGE, Mass., Oct. 13, 2025 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc . (Nasdaq: BIIB, Headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced today that LEQEMBI ® IQLIK™, a subcutaneous autoinjector formulation of lecanemab (generic name), for the treatment of Alzheimer’s disease (AD) has been selected by TIME as one... Read More

An analysis designed to evaluate the potential effects of the Phase 3 zorevunersen dosing regimen showed continuing improvements in cognition and behavior at 2 years; results contrast with minimal change in natural history – Improvements in overall clinical status at 3 years in the open-label extension studies reported by clinicians and caregivers in 95% of patients treated with zorevunersen CAMBRIDGE, Mass. and BEDFORD,... Read More

New LEQEMBI Companion TM program launched to expand helpful resources for patients throughout the treatment journey, including Nurse Educators who can provide patients with injection training, and an injection tracking tool and more LEQEMBI IQLIK, approved by the U.S. FDA in August 2025 , is the first and only anti-amyloid treatment to offer an at-home injection after initial treatment of 18 months TOKYO and CAMBRIDGE, Mass.... Read More

TOKYO and CAMBRIDGE, Mass., Sept. 28, 2025 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced today that humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody “LEQEMBI ® ” (brand name in China: “乐意保 ® ”, generic name: lecanemab) has been... Read More

TOKYO and CAMBRIDGE, Mass., Sept. 24, 2025 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced today that the Therapeutic Goods Administration (TGA) of Australia has approved the humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody “LEQEMBI ®... Read More

CAMBRIDGE, Mass., Sept. 23, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for the Company’s supplemental New Drug Application (sNDA) for the high dose regimen of nusinersen for the treatment of spinal muscular atrophy (SMA). The FDA letter requested an update to the technical information be included in the Chemistry... Read More

Biogen to drive end-to-end development and commercialization of ThecaFlex DRx™, an investigational implantable device for intrathecal delivery of antisense oligonucleotides (ASOs) ThecaFlex DRx™ has the potential to be a new, convenient way to administer medicines to patients living with neurological disorders. CAMBRIDGE, Mass., Sept. 18, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) announced the company has entered... Read More

Postpartum depression is a leading cause of maternal mortality in Europe 1-2 , and is one of the most common medical conditions associated with pregnancy 3-5 ; up to 20% of women experience postpartum depressive symptoms 6 -1 1 The approval of this new therapeutic approach introduces an oral, 14-day treatment specifically indicated for PPD The EC approval of ZURZUVAE is based on the SKYLARK study, which demonstrated rapid... Read More

LEQEMBI IQLIK, if approved for initiation dosing, would be the first and only anti-amyloid treatment to offer at-home injection from the start to help patients and care partners treat this progressive, relentless disease TOKYO and CAMBRIDGE, Mass., Sept. 02, 2025 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge,... Read More

A link has been updated in this news release, FDA Approves LEQEMBI® IQLIK™ (lecanemab-irmb) Subcutaneous Injection for Maintenance Dosing for the Treatment of Early Alzheimer's Disease, issued 29-Aug-2025 by Eisai Inc. over PR Newswire. LEQEMBI IQLIK is the first and only anti-amyloid treatment to offer an at-home injection to help patients and care partners continue to treat this progressive, relentless disease after... Read More

Durable reductions in seizures and continuing improvements in cognition and behavior through 3 years in patients who continued to receive zorevunersen in the open-label extension studies Substantial increase in seizure-free days and continuous improvements in quality of life demonstrated in patients already taking standard of care anti-seizure medicines Zorevunersen generally well tolerated across all studies Data support... Read More

LEQEMBI IQLIK is the first and only anti-amyloid treatment to offer an at-home injection to help patients and care partners continue to treat this progressive, relentless disease after initial treatment of 18 months LEQEMBI IQLIK will be launched on October 6, 2025, in the U.S. TOKYO and CAMBRIDGE, Mass., Aug. 29, 2025 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc.... Read More

3-year data from open-label extension (OLE) studies demonstrate the potential for disease modification with durable seizure reductions and improvements in cognition and behavior on top of standard anti-seizure medicines Substantial improvement in overall seizure burden and seizure free days observed with ongoing treatment CAMBRIDGE, Mass. and BEDFORD, Mass., Aug. 25, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) and... Read More

TOKYO and CAMBRIDGE, Mass., Aug. 25, 2025 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced today that the anti-amyloid beta (Aβ) monoclonal antibody “LEQEMBI ® ” has been launched in Austria on August 25, 2025 and will be launched in Germany on September 1,... Read More

Global, pivotal Phase 3 study will evaluate efficacy and safety of zorevunersen compared to sham over a 52-week treatment period Dravet syndrome is a rare genetic disease characterized by refractory seizures and neurodevelopmental impairments, with no currently approved medicines that address the underlying cause of the disease CAMBRIDGE, Mass. and BEDFORD, Mass., Aug. 11, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB)... Read More

TOKYO and CAMBRIDGE, Mass., July 30, 2025 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced today that the two-year real-world study in the U.S of lecanemab (generic name, product name: LEQEBMI ® ), an anti-Aβ protofibril* antibody, was presented at the... Read More

Lecanemab subcutaneous autoinjector has the potential to become a new expanded treatment option for patients with early Alzheimer's disease, their care partners and healthcare professionals, with results showing a comparable efficacy and safety profile to the intravenous formulation TOKYO and CAMBRIDGE, Mass. , July 30, 2025 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo , CEO: Haruo Naito , "Eisai") and Biogen Inc.... Read More

Data Showed LEQEMBI Slowed Clinical Decline by 1.75 Points on CDR-SB at Four Years Compared to the Natural History of Alzheimer's Disease 56% of Patients with Low Tau Continued to Demonstrate Improved Cognitive and Daily Living Function at Four Years TOKYO and CAMBRIDGE, Mass. , July 30, 2025 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo , CEO: Haruo Naito , "Eisai") and Biogen Inc. (Nasdaq: BIIB, Headquarters:... Read More

CAMBRIDGE, Mass., July 25, 2025 (GLOBE NEWSWIRE) -- Biogen Inc . (Nasdaq: BIIB) announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending marketing authorization for ZURZUVAE ® (zuranolone) for the treatment of postpartum depression (PPD) in adults following childbirth. If approved by the European Commission (EC), ZURZUVAE will be the... Read More

Lecanemab presentations to include long-term Clarity AD data, real-world treatment insights, and a subcutaneous formulation for continued care Presentations on tau to explore its biological role, the development of targeted therapies and biomarkers, and the future integration of these innovations into clinical practice CAMBRIDGE, Mass., July 21, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced upcoming... Read More

Investment builds on Biogen’s 30-year history of manufacturing in the region, with approximately $10 billion invested to date CAMBRIDGE, Mass., July 21, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) – today announced it intends to invest an additional $2 billion in its existing manufacturing footprint in North Carolina’s Research Triangle Park (RTP). Since breaking ground in 1995, Biogen’s manufacturing in RTP has... Read More

Data from an analysis designed to evaluate the potential effects of the Phase 3 zorevunersen dosing regimen showed improvements in cognition and behavior at Week 68 These findings support the inclusion of key secondary endpoints assessing cognition and behavior in the Phase 3 EMPEROR study and contrast with outcomes observed in natural history data CAMBRIDGE, Mass. and BEDFORD, Mass., July 10, 2025 (GLOBE NEWSWIRE) -- Biogen... Read More

Global Phase 3 PROMINENT study will evaluate the efficacy and safety of felzartamab, as compared to tacrolimus, in adults with primary membranous nephropathy (PMN) There are currently no therapies specifically approved for PMN, a rare immune-mediated disease affecting the kidneys with an estimated prevalence of ~36k patients in the U.S. 1 Felzartamab, an investigational anti-CD38 monoclonal antibody, is a potentially... Read More

New analyses from DEVOTE Part C further characterize the improvements in motor function in participants with SMA who transitioned to the investigational higher dose regimen of nusinersen from 12 mg SPINRAZA ® (nusinersen) Final results from the landmark NURTURE study highlight the profound impact of early treatment with 12 mg SPINRAZA in clinically presymptomatic SMA with 92% of children achieving the ability to walk... Read More

Salanersen (BIIB115/ION306) is a novel antisense oligonucleotide (ASO) with the potential to achieve high efficacy and once yearly dosing in spinal muscular atrophy (SMA) Interim Phase 1 data show children with SMA previously treated with gene therapy experienced a substantial slowing of neurodegeneration and clinically meaningful improvements in motor function following initiation of salanersen Based on these encouraging... Read More

Global Phase 3 BRAVE study will evaluate the efficacy and safety of omaveloxolone in children 2 to <16 years old with Friedreich ataxia, a rare neurodegenerative disorder BRAVE study will explore the potential of omaveloxolone to address the critical unmet need of the pediatric FA population Omaveloxolone is currently marketed under the brand name SKYCLARYS ® for the treatment of adults and adolescents aged 16 years and... Read More

Dapirolizumab pegol (DZP) showed efficacy across multiple clinical endpoints in the PHOENYCS GO study, including fatigue and measures of disease activity DZP showed consistent improvements in fatigue, a common and debilitating symptom of systemic lupus erythematosus (SLE) At Week 48, more individuals receiving DZP experienced no or low disease activity compared to standard of care with differences observed as early as Week... Read More

Collaboration leverages City Therapeutics’ next-generation RNAi engineering technologies and Biogen’s extensive drug development expertise CAMBRIDGE, Mass., May 27, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) and City Therapeutics, Inc., a privately held biopharmaceutical company leading the future of RNA interference (RNAi)-based medicine, today announced a strategic collaboration to develop select novel RNAi... Read More

In the European Union (EU), lecanemab is indicated for the treatment of adult patients with a clinical diagnosis of mild cognitive impairment and mild dementia due to Alzheimer’s disease (early AD) who are apolipoprotein E ε4 (ApoE ε4 * ) non-carriers or heterozygotes with confirmed amyloid pathology Lecanemab is the first therapy that targets an underlying cause of the disease to be authorized in the EU for eligible people... Read More

CAMBRIDGE, Mass., April 02, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to BIIB080, an investigational antisense oligonucleotide (ASO) therapy targeting tau, for the treatment of Alzheimer’s disease. Fast Track designation is intended to facilitate the development and expedite the review of investigational drugs that... Read More

Biogen signs lease for Kendall Common as part of multi-year real estate optimization plan to modernize its facilities and consolidate its Massachusetts real estate footprint New building will be designed to foster collaboration and spark innovation; Biogen plans to relocate Cambridge-based employees to the new site in 2028 CAMBRIDGE, Mass., March 24, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) announced plans for its... Read More

Global Phase 3 TRANSCEND study will evaluate the efficacy and safety of felzartamab, as compared to placebo, in adults with late AMR AMR is a leading cause of kidney transplant loss, with approximately ~23k patients living with all forms of AMR in the U.S 1 Felzartamab, with demonstrated proof of concept in multiple immune-mediated diseases, represents a key asset in Biogen’s late-stage immunology portfolio CAMBRIDGE, Mass.,... Read More

TOKYO and CAMBRIDGE, Mass. , Feb. 28, 2025 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo , CEO: Haruo Naito , "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts , CEO: Christopher A. Viehbacher , "Biogen") announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has reaffirmed its positive opinion by consensus for the anti-Aβ... Read More

Stoke retains exclusive rights for zorevunersen in the United States, Canada, and Mexico; Biogen receives exclusive rest of world commercialization rights Collaboration broadens Biogen’s rare disease pipeline and leverages global expertise commercializing high-value, disease-modifying medicines for rare genetic diseases Pivotal Phase 3 EMPEROR study of zorevunersen on track to initiate in Q2 2025 with an anticipated readout... Read More

TOKYO and CAMBRIDGE, Mass., Jan. 31, 2025 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced today an update on the ongoing regulatory review of the Marketing Authorization Application for lecanemab as treatment for early AD (mild cognitive impairment due to... Read More

Once every four weeks maintenance dosing may be easier for patients and care partners to continue treatment Alzheimer's disease progression does not stop after plaque clearance; ongoing treatment with LEQEMBI can slow disease progression and prolong the benefits of therapy TOKYO and CAMBRIDGE, Mass. , Jan. 26, 2025 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo , CEO: Haruo Naito , "Eisai") and Biogen Inc. (Nasdaq:... Read More

CAMBRIDGE, Mass., Jan. 23, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental New Drug Application (sNDA) and the European Medicines Agency (EMA) has validated the application for a higher dose regimen of nusinersen for spinal muscular atrophy (SMA). The higher dose regimen of nusinersen comprises a more rapid loading regimen,... Read More

LEQEMBI is the only FDA-approved anti-amyloid therapy that potentially could offer the convenience of a subcutaneous injection with at-home administration option TOKYO and CAMBRIDGE, Mass. , Jan. 13, 2025 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo , CEO: Haruo Naito , "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts , CEO: Christopher A. Viehbacher , "Biogen") announced today... Read More

TOKYO and CAMBRIDGE, Mass. , Dec. 4, 2024 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo , CEO: Haruo Naito , "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts , CEO: Christopher A. Viehbacher , "Biogen") announced today that the Federal Commission for the Protection Against Sanitary Risk (COFEPRIS) in Mexico has approved humanized anti-soluble aggregated amyloid-beta (Aβ)... Read More

TOKYO and CAMBRIDGE, Mass. , Nov. 27, 2024 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo , CEO: Haruo Naito , "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts , CEO: Christopher A. Viehbacher, "Biogen") announced today that the humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody "LEQEMBI ® " has been launched in South Korea . LEQEMBI received the Ministry of... Read More

Dapirolizumab pegol (DZP) met its primary endpoint, demonstrating statistically and clinically significant improvement across all organ systems as measured by BICLA, an endpoint measuring disease activity A greater response was observed across multiple clinical endpoints among participants treated with DZP including 50% less severe disease flares compared to participants on standard of care alone Systemic Lupus Erythematosus... Read More

OPUVIZ™ is one of the first wave aflibercept biosimilars in Europe OPUVIZ is the second European Commission (EC)-approved ophthalmology biosimilar under Samsung Bioepis and Biogen’s partnership EC approval based on robust totality of evidence confirming biosimilarity to reference aflibercept in terms of quality, efficacy, and safety INCHEON, South Korea and CAMBRIDGE, Mass., Nov. 18, 2024 (GLOBE NEWSWIRE) -- Samsung Bioepis... Read More

TOKYO and CAMBRIDGE, Mass., Nov. 14, 2024 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced today a positive opinion has been received from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending approval... Read More

New testing method highlights link between protofibrils and biomarkers for neurodegeneration Patient and caregiver perspectives on five-year treatment with lecanemab Utilization of blood biomarkers to predict brain amyloid accumulation in AHEAD study of preclinical AD TOKYO and CAMBRIDGE, Mass., Oct. 30, 2024 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. ( Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB,... Read More

The collaboration aims to discover and develop molecular glue degrader clinical candidates for priority targets to Biogen. Collaboration leverages Neomorph's leading molecular glue discovery platform and Biogen’s deep expertise in Alzheimer’s, rare, and immunological diseases. CAMBRIDGE, Mass. and SAN DIEGO, Calif., Oct. 29, 2024 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) and Neomorph Inc. announced a research... Read More

CAMBRIDGE, Mass., Oct. 29, 2024 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) has appointed Daniel Quirk, M.D., M.P.H., M.B.A. as Chief Medical Officer and Head of Medical Affairs, effective October 28, 2024. Dr. Quirk will report to Priya Singhal, M.D., M.P.H., Head of Development at Biogen. “At Biogen, scientific and medical leadership is the foundation for everything we do, and this is why we believe Dan will be a... Read More

CAMBRIDGE, Mass., Oct. 28, 2024 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced that Michael McDonnell, Biogen’s Executive Vice President and Chief Financial Officer, plans to retire from the company on February 28, 2025. Upon Mr. McDonnell’s retirement, Robin Kramer, currently Chief Accounting Officer at Biogen, will assume the role of Chief Financial Officer (CFO). In the coming weeks and months, Mr.... Read More

The detailed study results confirmed interim findings, showing stable kidney function and sustained treatment effect more than 18 months after the last dose of felzartamab Felzartamab, an investigational anti-CD38 monoclonal antibody, is a potential first-in-class therapeutic candidate for a range of rare immune-mediated indications with planning underway for Phase 3 development IgA Nephropathy (IgAN) is a leading cause of... Read More

CAMBRIDGE, Mass., Oct. 24, 2024 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) announced upcoming data presentations and programming at the Clinical Trials on Alzheimer’s Disease (CTAD) annual conference, taking place October 29 - November 1, in Madrid, Spain. The presentations will include updates on new scientific findings from Biogen’s Alzheimer’s portfolio, highlighting data on different aspects of treatment and data... Read More

Late breaker oral presentation to feature final results of the Phase 2 IGNAZ study of felzartamab for IgA nephropathy Additional oral presentation to examine the impact of felzartamab on key disease-relevant biomarkers Felzartamab, an investigational anti-CD38 monoclonal antibody, is a potential first-in-class therapeutic candidate for a range of rare immune-mediated indications with planning underway for Phase 3 development... Read More

Designation is based on data from the clinical development program which demonstrated clinical proof of concept Felzartamab, an investigational anti-CD38 monoclonal antibody, is a potential first-in-class therapeutic candidate for a range of rare immune-mediated indications with planning underway for Phase 3 development FDA Breakthrough Therapy Designation is intended to expedite the development and review of drugs for... Read More

Findings from Part B and Part C of the DEVOTE study support the clinical benefits of a higher dose regimen of nusinersen (50/28 mg) in both individuals previously treated and treatment-naïve to nusinersen Investigational regimen also shows more rapid slowing of neurodegeneration, as measured by neurofilament Biogen plans to submit regulatory applications around the world for approval of the nusinersen higher dose regimen... Read More

Phase 3 PHOENYCS GO study met the primary endpoint demonstrating clinical improvement in moderate-to-severe systemic lupus erythematosus; Clinical improvements were observed among key secondary endpoints measuring disease activity and flares. UCB and Biogen are advancing dapirolizumab pegol with the objective to address the substantial unmet medical need for people living with SLE, where there are limited treatment options.... Read More

OPUVIZ™, a biosimilar referencing Eylea 1 (aflibercept), is Samsung Bioepis and Biogen’s second ophthalmology biosimilar to be recommended for marketing authorization by the European Medicines Agency INCHEON, South Korea and CAMBRIDGE, Mass., Sept. 20, 2024 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products... Read More

CAMBRIDGE, Mass., Sept. 12, 2024 (GLOBE NEWSWIRE) -- The Biogen Inc. (Nasdaq: BIIB) Board of Directors (the “Board”) today announced the appointments of two new independent directors, Lloyd B. Minor, M.D., effective October 1, 2024, and Sir Menelas (Mene) Pangalos, Ph.D., effective January 1, 2025. Dr. Minor is currently the Dean of the Stanford University School of Medicine and Vice President for Medical Affairs at Stanford... Read More

Positive study demonstrates the potential for investigational higher dose nusinersen regimen to advance the treatment of SMA; Biogen plans to submit for regulatory approval of this investigational dose regimen Higher dose nusinersen regimen showed statistically significant improvement compared to a prespecified matched sham control group Among key measures of clinical efficacy, higher dose regimen showed positive trends... Read More

In Great Britain, lecanemab is indicated for the treatment of mild cognitive impairment and mild dementia due to Alzheimer's disease (AD) in adult patients that are apolipoprotein E ε4 (ApoE ε4)* heterozygotes or non-carriers 1 Great Britain becomes the first country in Europe to authorize the medicine, which targets an underlying cause of AD 1 TOKYO and CAMBRIDGE, Mass. , Aug. 22, 2024 /PRNewswire/ -- Eisai Co., Ltd.... Read More

Alcyone's ThecaFlex is an implantable medical device under investigation for routine subcutaneous administration of therapeutics to the cerebrospinal fluid (CSF). The first stage of the pivotal IDE PIERRE trial has been completed. 10 spinal muscular atrophy (SMA) patients have undergone ThecaFlex implantation and have received nusinersen through the device. No device-related adverse events, including infections, were... Read More

51% of No Tau / Low Tau Patients Showed Improved Cognition and Function Over Three Years; Only Lecanemab Has Clinical Data in No Tau / Low Tau Patient Group Clinical Data and Biomarkers Show Alzheimer's Disease Does Not Stop Progressing After Plaque Clearance. Lecanemab's Dual Action Supports Neuronal Function by Clearing Highly Toxic Protofibrils that Continue to Cause Neuronal Injury and Death After Rapid Plaque Clearance... Read More

The collaboration aims to identify and develop accessible, minimally invasive blood-based biomarkers specific for tau pathology in the brain These tools have the potential to be used to stratify patients or monitor treatment response for a new generation of future therapies impacting tau pathology in Alzheimer’s disease CAMBRIDGE, Mass. and BREA, Calif. and TOKYO, July 30, 2024 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB),... Read More

TOKYO and CAMBRIDGE, Mass., July 26, 2024 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a negative opinion on the Marketing... Read More

CAMBRIDGE, Mass., July 02, 2024 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) has completed the acquisition of Human Immunology Biosciences (HI-Bio™), a privately-held clinical-stage biotechnology company focused on targeted therapies for patients with severe immune-mediated diseases (IMDs). “We are very excited about the addition of felzartamab into our pipeline, further strengthening our presence in immunology with a... Read More

TOKYO and CAMBRIDGE, Mass., June 27, 2024 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced today that the humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody “LEQEMBI ® ” (brand name in China: “乐意保 ® ”, generic name: lecanemab) has been... Read More

TOFIDENCE™ complements existing portfolio of immunology biosimilars commercialized by Biogen Cambridge, Mass., June 24, 2024 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) announced that the European Commission (EC) has granted approval for TOFIDENCE TM , a biosimilar monoclonal antibody referencing ROACTEMRA ®1 . The intravenous formulation of TOFIDENCE has been granted marketing authorization by the EC for the treatment of... Read More

TOKYO and CAMBRIDGE, Mass. , June 9, 2024 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo , CEO: Haruo Naito , "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts , CEO: Christopher A. Viehbacher , "Biogen") announced today that the U.S. Food and Drug Administration (FDA) has accepted Eisai's Supplemental Biologics License Application (sBLA) for monthly lecanemab-irmb (U.S. brand... Read More

Upcoming community events will inform plans to create more equitable flying experiences for passengers with reduced mobility CAMBRIDGE, Mass. and ATLANTA, June 03, 2024 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) and Delta Flight Products (DFP), a wholly-owned subsidiary of Delta Air Lines established to create aircraft interior solutions to airlines around the world, announced that the companies will collaborate to... Read More

SOD1 -ALS is a devastating, uniformly fatal, and ultra-rare genetic form of ALS estimated to affect less than 1,000 people in Europe 1 QALSODY is Biogen’s third rare disease therapy to be approved in the EU, demonstrating the company’s commitment to addressing diseases with a high unmet need With QALSODY, Biogen has helped advance neurofilament as a tool to optimize clinical trial design in ALS, offering the potential to... Read More

Transaction to include felzartamab, a potential first-in-class therapeutic candidate with promise as a pipeline-in-a-product across a range of immune-mediated diseases Felzartamab is an investigational anti-CD38 monoclonal antibody that, through its cell depletion approach, has demonstrated clinical proof of concept in rare immune-mediated indications, with plans to advance to Phase 3 Proposed acquisition builds on Biogen... Read More

Development of BIIB105, an investigational antisense oligonucleotide for amyotrophic lateral sclerosis (ALS), will be discontinued based on data from the Phase 1/2 ALSpire study Biogen and Ionis continue their long-standing commitment to developing therapies for ALS given the devastating impact of this progressive, fatal neurodegenerative condition CAMBRIDGE, Mass. and CARLSBAD, Calif., May 16, 2024 (GLOBE NEWSWIRE) --... Read More

TOKYO and CAMBRIDGE, Mass. , May 14, 2024 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo , CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts , CEO: Christopher A. Viehbacher, "Biogen") announced today that Eisai has initiated the rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for lecanemab-irmb (U.S.... Read More

Efforts focused on four areas: access and health equity, workforce and DE&I, community impact and the environment CAMBRIDGE, Mass., May 02, 2024 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced publication of its 2023 Corporate Responsibility Report detailing progress on the company’s commitment to making responsible business decisions in the best interests of all its stakeholders. “As we reflect on the past... Read More

CHMP positive opinion is based on a robust analytical, non-clinical and clinical data package comparing TOFIDENCE™ to the reference product ROACTEMRA ® CAMBRIDGE, Mass., April 25, 2024 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for TOFIDENCE™ (tocilizumab), a biosimilar... Read More

TOKYO and CAMBRIDGE, Mass. , March 31, 2024 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo , CEO: Haruo Naito , "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts , CEO: Christopher A. Viehbacher , "Biogen") announced today that Eisai submitted to the U.S. Food and Drug Administration (FDA) a Supplemental Biologics License Application (sBLA) for monthly lecanemab-irmb (U.S. brand... Read More

New data from the RESPOND study show that neurofilament levels, an indicator of neurodegeneration, were reduced in nearly all study participants treated with SPINRAZA Reductions in biomarker complement previously reported RESPOND efficacy results showing improved motor function in most participants treated with SPINRAZA after gene therapy CAMBRIDGE, Mass., March 06, 2024 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB)... Read More

New data advances understanding of new approaches to treating Alzheimer’s disease Research on disease progression could help inform future clinical trials CAMBRIDGE, Mass., March 04, 2024 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) announced it will present new data from its Alzheimer’s disease (AD) portfolio at the upcoming International Conference on Alzheimer’s and Parkinson’s Diseases (AD/PD™ 2024), taking place March... Read More

SOD1 -ALS is a devastating, uniformly fatal, and ultra-rare genetic form of ALS affecting less than 1,000 people in Europe 1 With QALSODY, Biogen has advanced the role of neurofilament in the development of new medicines for ALS, with the potential to accelerate further discovery in the field CAMBRIDGE, Mass., Feb. 23, 2024 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) announced the Committee for Medicinal Products for... Read More

Friedreich’s ataxia is a rare, genetic, life-shortening, debilitating, and neurodegenerative disorder Treatment with SKYCLARYS improved patient function compared to placebo Biogen is leveraging its expertise and capabilities in rare disease to bring this groundbreaking treatment to patients CAMBRIDGE, Mass., Feb. 12, 2024 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) announced the European Commission (EC) has authorized... Read More

Company to reprioritize resources allocated to ADUHELM ® (aducanumab-avwa) to advance LEQEMBI ® (lecanemab-irmb) and to develop new treatment modalities Biogen committed to building a leading Alzheimer’s disease franchise to address patient needs CAMBRIDGE, Mass., Jan. 31, 2024 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced plans to reprioritize its resources in Alzheimer’s disease (AD), a strategic... Read More

CAMBRIDGE, Mass., Dec. 19, 2023 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced that the European Commission has revoked the centralized marketing authorizations for generic versions of Biogen’s product TECFIDERA® (dimethyl fumarate) held by Accord, Mylan, Neuraxpharm, Polpharma and Teva. In reaching this decision, the European Commission affirmed that Biogen is entitled to full data protection and marketing... Read More

Friedreich’s ataxia is a genetic, debilitating and life-shortening neuromuscular disease 1 Milestone highlights Biogen’s growing portfolio in rare diseases and focus on addressing unmet needs of patients living with neuromuscular diseases CAMBRIDGE, Mass., Dec. 15, 2023 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA)... Read More

ZURZUVAE, the first and only oral, once-daily, 14-day treatment course, has shown to provide rapid improvements in depressive symptoms at Day 15 and as early as Day 3 for women with PPD Patient support program, ZURZUVAE For You, and financial assistance available to eligible women with PPD prescribed ZURZUVAE Patients will receive prescriptions directly at home via specialty pharmacy distribution model CAMBRIDGE, Mass., Dec.... Read More

CAMBRIDGE, Mass., Nov. 06, 2023 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced the appointment of Monish Patolawala, currently President and Chief Financial Officer of 3M Company (“3M”), to the Company’s Board of Directors (the “Board”), effective January 1, 2024. As an accomplished financial executive, Mr. Patolawala is qualified as an Audit Committee financial expert and may be asked to serve as a member of... Read More

INVESTIGATIONAL SUBCUTANEOUS FORMULATION CLEARS 14% MORE PLAQUE THAN IV, PHARMACOKINETICS (AUC) 11% HIGHER, AND SIMILAR ARIA RATES TO IV 76% OF PATIENTS SHOWED NO DECLINE AND 60% SHOWED CLINICAL IMPROVEMENT AT 18 MONTHS IN LOW-TAU SUBPOPULATION IN ADDITIONAL ANALYSIS OF CLARITY AD DUAL-ACTING LEQEMBI SUPPORTS BRAIN NEURON FUNCTION BY REMOVING HIGHLY TOXIC PROTEINS (PROTOFIBRILS) THAT CAN CONTINUE TO CAUSE NEURONAL INJURY AND... Read More

In the Phase 1b study, favorable trends were reported for the high-dose groups on multiple measures of cognition and function. First study of a tau targeting drug that shows reduction of aggregated tau pathology and favorable trends on clinical outcomes. Recruitment is underway for the Phase 2 CELIA study further investigating clinical efficacy and safety. CAMBRIDGE, Mass., Oct. 25, 2023 (GLOBE NEWSWIRE) -- Biogen Inc.... Read More

Recognized in the Medical Care Category NUTLEY, N.J. , and CAMBRIDGE, Mass. , Oct. 24, 2023 /PRNewswire/ -- Eisai Inc. and Biogen Inc. are honored to announce today that TIME has selected LEQEMBI® (lecanemab-irmb) as one of the Best Inventions of 2023 in the Medical Care category. LEQEMBI is the first and only approved treatment for patients with mild cognitive impairment or mild dementia stage of Alzheimer's disease (AD).... Read More

Late-breaking Phase 1b data assesses the clinical outcomes of reducing tau in patients with early-stage Alzheimer’s disease Additional late-breaking presentations from the CLARITY AD study explore predictive biomarkers and novel subcutaneous administration of LEQEMBI ® (lecanemab-irmb) CAMBRIDGE, Mass., Oct. 19, 2023 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) will present new data from its Alzheimer’s disease portfolio... Read More

TOFIDENCE (BIIB800) becomes the first tocilizumab biosimilar to gain FDA approval in the United States FDA approval is based on a robust analytical, non-clinical and clinical data package comparing TOFIDENCE to the reference product ACTEMRA CAMBRIDGE, Mass., Sept. 29, 2023 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) announced that the U.S. Food and Drug Administration (FDA) has approved TOFIDENCE (tocilizumab-bavi)... Read More

Reata acquisition bolsters Biogen’s rare disease portfolio with the addition of SKYCLARYS ® (omaveloxolone), the first and only FDA approved treatment for Friedreich’s ataxia in the U.S. CAMBRIDGE, Mass., Sept. 26, 2023 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) – has completed the acquisition of Reata Pharmaceuticals, Inc. (Nasdaq: RETA), a company focused on developing therapeutics that regulate cellular metabolism and... Read More

TOKYO and CAMBRIDGE, Mass., Sept. 25, 2023 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced today that humanized anti- soluble aggregated amyloid-beta (Aβ) monoclonal antibody LEQEMBI ® Intravenous Infusion (200 mg, 500mg, lecanemab) has been approved in... Read More

CAMBRIDGE, Mass., Sept. 06, 2023 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) announced the appointment of Jane Grogan, Ph.D., as Executive Vice President, Head of Research effective 2 October 2023. Dr. Grogan will be a member of Biogen’s Executive Committee reporting to Christopher A. Viehbacher, President and Chief Executive Officer. “Dr. Grogan is a pioneering scientist whose groundbreaking discoveries at Genentech... Read More

Postpartum depression (PPD) approval based on results from two Phase 3 clinical trials; in the SKYLARK Study treatment with ZURZUVAE rapidly improved symptoms of PPD at Day 15 and as early as Day 3 with sustained effect to Day 45 Mental health conditions are the leading cause of maternal mortality 1 with PPD among the most common complications during and after pregnancy 2 CAMBRIDGE, Mass., Aug. 04, 2023 (GLOBE NEWSWIRE) --... Read More

SKYCLARYS ® recently approved in US as the only treatment indicated for patients with Friedreich’s ataxia Proposed acquisition represents meaningful step forward in Biogen’s strategy for sustainable growth, adding a highly complementary innovative product in an area of high unmet medical need Expected to be significantly accretive to Biogen’s Non-GAAP diluted EPS beginning in 2025 Biogen to host investor conference call... Read More

Further Phase 3 analysis shows benefits of lecanemab on both amyloid-beta and tau, two underlying pathological hallmarks of Alzheimer’s disease New data on subcutaneous formulation shows promising PK /PD data modeling on efficacy and safety, representing a potential new option for administering therapy TOKYO and CAMBRIDGE, Mass., July 19, 2023 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito,... Read More

The first and only approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline in adults with Alzheimer’s disease The Centers for Medicare & Medicaid Services (CMS) announced broader Medicare coverage of LEQEMBI TOKYO and CAMBRIDGE, Mass., July 06, 2023 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB,... Read More

Interim results from the RESPOND study show improved motor function in most participants treated with SPINRAZA after Zolgensma ® (onasemnogene abeparvovec) Biogen also reported new real-world evidence and progress on the development of a novel device to enhance the patient treatment experience CAMBRIDGE, Mass., June 30, 2023 (GLOBE NEWSWIRE) -- Biogen Inc . (Nasdaq: BIIB) announced new SPINRAZA ® (nusinersen) data aimed at... Read More

Biogen Will Adjourn Its Annual Meeting of Stockholders Until June 26, 2023, to Give All Stockholders Sufficient Time to Review and Vote on Proposed Slate CAMBRIDGE, Mass., June 12, 2023 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) announced several changes to its Board of Directors today. The changes will refresh the composition of the Board and follow the Board’s continual interaction with company stockholders to solicit... Read More

Peripheral and Central Nervous System Drugs Advisory Committee voted based on data from large global confirmatory Phase 3 Clarity AD clinical trial in patients living with early Alzheimer's disease The PDUFA action date for traditional approval of LEQEMBI has been set for July 6, 2023 , with designation of priority review LEQEMBI received accelerated approval from the FDA for the treatment of early Alzheimer's disease on... Read More

TOKYO and CAMBRIDGE, Mass., May 15, 2023 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced today that Health Canada has accepted a New Drug Submission (NDS) for lecanemab (brand name in the U.S.: LEQEMBI™), an investigational anti-amyloid beta (Aβ)... Read More

FDA granted accelerated approval of QALSODY based on a reduction of neurofilament, a marker of neurodegeneration 1 Superoxide dismutase 1 ( SOD1 )-amyotrophic lateral sclerosis (ALS) is a devastating, uniformly fatal, 2 and ultra-rare genetic form of ALS 3-4 with approximately 330 people in the U.S. living with the disease 5 CAMBRIDGE, Mass., April 25, 2023 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) announced today that... Read More

CAMBRIDGE, Mass., April 04, 2023 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced the appointment of Adam Keeney, Ph.D., as Executive Vice President, Head of Corporate Development effective 17 April 2023. Dr. Keeney will be a member of Biogen’s Executive Committee reporting to Christopher A. Viehbacher, President and Chief Executive Officer. “We welcome Adam Keeney to our executive leadership team in this... Read More

TOKYO and CAMBRIDGE, Mass., March 30, 2023 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced today that three additional detailed analyses from the Phase IIb clinical study (Study 201), evaluating the efficacy and safety of lecanemab for mild cognitive... Read More

TOKYO and CAMBRIDGE, Mass., March 30, 2023 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced today that Eisai presented new analyses on amyloid-related imaging abnormalities (ARIA) with the use of antiplatelet and anticoagulant medications, isolated ARIA-H,... Read More

The BIIB080 Phase 1b clinical study is the first to show a reduction of this magnitude in tau PET across brain regions Phase 1b Study of BIIB080 showed dose-dependent and sustained reduction of tau protein (CSF t-tau and p-tau181) in the cerebral spinal fluid (CSF) throughout the open-label long-term extension (LTE) Neurofibrillary tangles in the brain are composed of tau proteins and are a key pathology associated with... Read More

CAMBRIDGE, Mass., March 22, 2023 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) announced today the outcome of the U.S. Food and Drug Administration’s (FDA) Peripheral and Central Nervous System Drugs Advisory Committee meeting on tofersen, an investigational product for the treatment of superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS). On the question, “Is the available evidence sufficient to conclude that... Read More

CAMBRIDGE, Mass., March 16, 2023 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced that the Court of Justice of the European Union decided in favor of Biogen, the European Medicines Agency (EMA), and the European Commission in their appeal of a General Court decision annulling the EMA’s refusal to evaluate a generic version of TECFIDERA ® (dimethyl fumarate) because of TECFIDERA’s regulatory data and marketing... Read More

CAMBRIDGE, Mass., March 14, 2023 (GLOBE NEWSWIRE) -- Biogen Inc. (NASDAQ: BIIB) today announced the appointment of Chuck Triano as Senior Vice President, Head of Investor Relations effective 10 April 2023. Mr. Triano will report to Michael McDonnell, Executive Vice President and Chief Financial Officer. “Chuck will bring invaluable industry insights and a strong network of relationships to Biogen, and I’m pleased to welcome... Read More

CAMBRIDGE, Mass., March 08, 2023 (GLOBE NEWSWIRE) -- Biogen Inc . (NASDAQ: BIIB) today announced that the Board of Directors has elected Caroline Dorsa as Chair of the Board of Directors, effective immediately following the Company’s 2023 Annual Meeting of Stockholders (the “Annual Meeting”), scheduled to take place on June 14, 2023. Ms. Dorsa will succeed Stelios Papadopoulos, Ph.D., who announced he would not stand for... Read More

Confirmatory Phase 3 Clarity AD data to be evaluated by FDA in determining whether to convert accelerated approval of LEQEMBI to a traditional approval Priority Review accelerates FDA review time with a Prescription Drug User Fee Act (PDUFA) target action on July 6, 2023 TOKYO and CAMBRIDGE, Mass., March 05, 2023 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq:... Read More

TOKYO and CAMBRIDGE, Mass., Feb. 27, 2023 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced today that the Biologics License Application (BLA) for lecanemab (brand name in the U.S.: LEQEMBI™), an investigational anti-amyloid beta (Aβ) protofibril antibody, has... Read More

Zuranolone is being evaluated as a potential 14-day, rapid-acting, once-daily, oral medication to treat major depressive disorder (MDD) and postpartum depression (PPD) Depression is a public health issue with significant unmet medical need CAMBRIDGE, Mass., Feb. 06, 2023 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) and Sage Therapeutics, Inc. (Nasdaq: SAGE) announced the U.S. Food and Drug Administration (FDA) has accepted... Read More

TOKYO and CAMBRIDGE, Mass., Jan. 29, 2023 (GLOBE NEWSWIRE) -- Eisai Co., Ltd (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced today that an application for manufacturing and marketing approval for lecanemab (generic name, U.S. brand name: LEQEMBI™), an anti-amyloid-β (Aβ) protofibril *... Read More

TOKYO and CAMBRIDGE, Mass., Jan. 26, 2023 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced today that the European Medicines Agency (EMA) has accepted a marketing authorization application (MAA) for lecanemab (Brand Name in the U.S.: LEQEMBI™), an... Read More

TOKYO and CAMBRIDGE, Mass. , Jan. 15, 2023 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo , CEO: Haruo Naito , "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts , CEO: Christopher A. Viehbacher , "Biogen") announced today that Eisai has submitted a marketing authorization application for lecanemab (Brand Name in the U.S.: LEQEMBI™), an investigational anti-amyloid beta (Aβ)... Read More

TOKYO and CAMBRIDGE, Mass. , Jan. 10, 2023 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo , CEO: Haruo Naito , "Eisai") and Biogen Inc . (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts , CEO: Christopher A. Viehbacher , "Biogen") announced today that Eisai has submitted a marketing authorization application (MAA) for lecanemab (Brand Name in the U.S.: LEQEMBI™), an investigational anti-amyloid beta (Aβ)... Read More

Submission for traditional approval follows FDA accelerated approval of LEQEMBI on the same day, and is based on data from the confirmatory Phase 3 Clarity AD clinical trial TOKYO and CAMBRIDGE, Mass. , Jan. 6, 2023 /PRNewswire/ -- Eisai Co. , Ltd. (Headquarters: Tokyo , CEO: Haruo Naito , "Eisai") and Biogen Inc . (Nasdaq:... Read More

Accelerated Approval is based on Phase 2 data showing a reduction in amyloid-beta plaques in early AD patients treated with LEQEMBI™ Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials TOKYO and CAMBRIDGE, Mass. , Jan. 6, 2023 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo , CEO: Haruo... Read More

CAMBRIDGE, Mass., Jan. 05, 2023 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) announced that Priya Singhal, M.D., M.P.H., currently Head of Global Safety and Regulatory Sciences and Interim Head of Research & Development (R&D), has been promoted to Executive Vice President, Head of Development, following a decision to separate Research and Development into two distinct functions that will both report directly to the CEO. In... Read More

Alcyone’s ThecaFlex DRx™ System is an implantable medical device in development for intrathecal drug delivery CAMBRIDGE, Mass. and LOWELL, Mass., Jan. 04, 2023 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) and Alcyone Therapeutics (Alcyone) have entered into a license and collaboration agreement to develop Alcyone’s ThecaFlex DRx™ System, an implantable medical device intended for subcutaneous delivery of antisense... Read More

TOKYO and CAMBRIDGE, Mass. , Dec. 22, 2022 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo , CEO: Haruo Naito , "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts , CEO: Christopher A. Viehbacher , "Biogen") announced today that Eisai has initiated submission of data for Biologics License Application (BLA) to the National Medical Products Administration (NMPA) of China for lecanemab... Read More

Glofitamab is an investigational T-cell engaging bispecific antibody targeting CD20 and CD3 in development for B-cell non-Hodgkin’s lymphoma and other blood cancers CAMBRIDGE, Mass., Dec. 19, 2022 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) announced that it has reached an agreement with Genentech, a member of the Roche Group, related to the commercialization and sharing of economics for glofitamab. Under the terms of the... Read More

CAMBRIDGE, Mass., Dec. 09, 2022 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) – announced that the U.S. Food and Drug Administration (FDA) has accepted for review the abbreviated Biologics License Application (aBLA) for BIIB800, a biosimilar candidate referencing ACTEMRA® 1 (tocilizumab), an anti-interleukin-6 receptor monoclonal antibody. ACTEMRA® is indicated for several indications, including moderate to severe... Read More

SOD1-ALS is a rare, genetic form of ALS, 1 comprising approximately 2% of people with ALS 2 If approved, tofersen would be the first treatment to target a genetic cause of ALS CAMBRIDGE, Mass., Dec. 05, 2022 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) announced the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for review of tofersen, an investigational drug for the treatment of... Read More

TOKYO and CAMBRIDGE, Mass. , Nov. 29, 2022 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo , CEO: Haruo Naito , "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts , CEO: Christopher A. Viehbacher , "Biogen") announced today that the results from Eisai's large global Phase 3 confirmatory Clarity AD clinical study of lecanemab (development code: BAN2401), an investigational... Read More