Articles from Biogen Inc.

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 Alzheimer’s disease (AD) and mild AD) in the European Union.

Once every four weeks maintenance dosing may be easier for patients and care partners to continue treatment

Applications are based on data from the DEVOTE study, which demonstrate the potential for the investigational higher dose regimen of nusinersen to advance the treatment of SMA

LEQEMBI is the only FDA-approved anti-amyloid therapy that potentially could offer the convenience of a subcutaneous injection with at-home administration option

BRUSSELS, Belgium and CAMBRIDGE, Mass., Nov. 19, 2024 (GLOBE NEWSWIRE) -- UCB (Euronext Brussels: UCB) and Biogen Inc. (NASDAQBIIB) today presented detailed results from the Phase 3 PHOENYCS GO study evaluating dapirolizumab pegol (DZP), a novel Fc-free anti-CD40L drug candidate, demonstrating significant clinical improvement in disease activity in people living with moderate-to-severe systemic lupus erythematosus (SLE). The results were shared during an oral, late-breaker presentation at ACR Convergence 2024, the American College of Rheumatology’s annual meeting, in Washington, DC.

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 of the amyloid-beta (Aβ) monoclonal antibody lecanemab as a treatment of adult patients with a clinical diagnosis of mild cognitive impairment and mild dementia due to Alzheimer’s disease (Early Alzheimer’s disease) who are apolipoprotein E ε4 (ApoE ε4)* non-carriers or heterozygotes with confirmed amyloid pathology.1 Eisai had requested a re-examination of the prior negative opinion adopted by the CHMP in July 2024. In accordance with European Medicines Agency regulatory process, the European Commission is expected to make a final decision on the marketing authorization application (MAA) of lecanemab based on the CHMP recommendation within 67 days of receipt of CHMP opinion.2  

-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-

CAMBRIDGE, Mass. and SAN DIEGO, Calif., Oct. 29, 2024 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) and Neomorph Inc. announced a research collaboration to discover and develop molecular glue degraders for priority targets in Alzheimer’s, rare neurological, and immunological diseases.

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.

Robin Kramer, Chief Accounting Officer, to Succeed Him

CAMBRIDGE, Mass., Oct. 26, 2024 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) – today presented complete results from the Phase 2 IGNAZ study evaluating felzartamab, an investigational anti-CD38 monoclonal antibody, in people living with IgA nephropathy (IgAN). The results showed substantial reductions in proteinuria, stabilization of kidney function, and sustained treatment effect more than 18 months after the last dose of felzartamab. The complete results were shared during an oral presentation at Kidney Week 2024, the American Society of Nephrology’s annual meeting, in San Diego, California.

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 examining preclinical Alzheimer’s disease and race.

CAMBRIDGE, Mass., Oct. 22, 2024 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) – announced the company will present a variety of new data from its felzartamab clinical development program at Kidney Week 2024, the American Society of Nephrology’s (ASN) annual meeting, taking place October 23-27 in San Diego, California. Felzartamab, an investigational anti-CD38 monoclonal antibody, is a potential first-in-class therapeutic candidate for a range of rare immune-mediated diseases.

CAMBRIDGE, Mass., Oct. 09, 2024 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) – Biogen announced today that felzartamab, an investigational anti-CD38 monoclonal antibody, has received Breakthrough Therapy Designation (BTD) from the U.S. Food and Drug Administration (FDA) for the treatment of late antibody-mediated rejection (AMR) without T-cell mediated rejection in kidney transplant patients. The FDA grants BTD to drug candidates for serious or life-threatening conditions and that have preliminary clinical evidence demonstrating potential to provide substantial improvement over existing therapies. The designation provides additional opportunities to engage the FDA and to support the drug development program through Fast Track designation features.

CAMBRIDGE, Mass., Oct. 08, 2024 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced detailed results from Part B and Part C of the Phase 2/3 DEVOTE study evaluating the safety and efficacy of an investigational higher dose regimen of nusinersen in spinal muscular atrophy (SMA), showing benefits in both individuals previously treated and treatment-naïve to nusinersen with infantile-onset or later-onset SMA. The investigational, higher dose regimen of nusinersen comprises a more rapid loading regimen, two 50 mg doses 14 days apart, and higher maintenance regimen, 28 mg, every 4 months, compared to the approved nusinersen regimen (SPINRAZA®). Data to be presented during the World Muscle Society (WMS) 2024 Congress (Oct. 8-12, 2024 in Prague) highlight the potential of this investigational higher dose regimen to help address remaining unmet need in SMA.

BRUSSELS and CAMBRIDGE, Mass., Sept. 24, 2024 (GLOBE NEWSWIRE) -- UCB (Euronext Brussels: UCB) and Biogen Inc. (NASDAQBIIB) today announced positive topline results from the Phase 3 PHOENYCS GO study evaluating dapirolizumab pegol, a novel Fc-free anti-CD40L drug candidate, in people living with moderate-to-severe systemic lupus erythematosus (SLE). Dapirolizumab pegol, in addition to standard-of-care (SOC) treatment, met the primary endpoint to demonstrate greater improvement of moderate-to-severe disease activity as assessed by achievement of British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) after 48 weeks versus placebo in addition to SOC. Clinical improvements were observed among key secondary endpoints measuring disease activity and flares.

Dr. Lloyd Minor and Prof Sir Menelas Pangalos bring significant scientific expertise and considerable experience in medicine research and development

CAMBRIDGE, Mass., Sept. 04, 2024 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced positive, topline data from the pivotal cohort (Part B) of the Phase 2/3 DEVOTE study evaluating the safety and efficacy of a higher dose regimen of nusinersen in treatment-naïve, symptomatic infants with spinal muscular atrophy (SMA). The investigational higher dose regimen of nusinersen comprises a more rapid loading regimen, two 50 mg doses 14 days apart, and a higher maintenance regimen, 28 mg, every 4 months, compared to the approved nusinersen regimen (SPINRAZA). The study met its primary endpoint at six months, achieving a statistically significant improvement in motor function in infants who received the higher dose regimen as compared to a prespecified matched sham (untreated) control group from the ENDEAR study.

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

CAMBRIDGE, Mass. and BREA, Calif. and TOKYO, July 30, 2024 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB), Beckman Coulter, Inc. and Fujirebio announced a collaboration to potentially identify and develop blood-based biomarkers for tau pathology in the brain and to potentially clinically advance and potentially commercialize new tests for tau pathology in Alzheimer’s disease (AD). The development of tau-specific blood-based biomarkers that can measure a patient’s tau burden could provide critical insights into the underlying pathological processes of AD and may help advance the development of a new generation of therapies impacting tau pathology.

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 Authorization Approval (MAA) for the humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody lecanemab as treatment for early AD (mild cognitive impairment due to Alzheimer’s disease (AD) and mild AD).1

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).

China is the Third Country to Launch LEQEMBI Following the United States and Japan

TOKYO and CAMBRIDGE, Mass., June 09, 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 U.S. Food and Drug Administration (FDA) has accepted Eisai’s Supplemental Biologics License Application (sBLA) for monthly lecanemab-irmb (U.S. brand name: LEQEMBI®) intravenous (IV) maintenance dosing. A Prescription Drug User Fee Act (PDUFA) action date is set for January 25, 2025. LEQEMBI is indicated for the treatment of Alzheimer's disease (AD) in patients with mild cognitive impairment or mild dementia stage of disease (collectively referred to as early AD).

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 inform future enhancements to the air travel journey for passengers with reduced mobility. In the United States alone, approximately 5.5 million individuals rely on wheelchairs for mobility.1

CAMBRIDGE, Mass., May 30, 2024 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) announced the European Commission (EC) has granted marketing authorization under exceptional circumstances and maintained orphan designation for QALSODY® (tofersen) for the treatment of adults with amyotrophic lateral sclerosis (ALS) associated with a mutation in the superoxide dismutase 1 gene (SOD1-ALS). QALSODY is the first treatment approved in the European Union to target a genetic cause of ALS, also known as motor neuron disease (MND).

CAMBRIDGE, Mass. and SOUTH SAN FRANCISCO, Calif., May 22, 2024 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) and Human Immunology Biosciences (HI-Bio™), a privately-held clinical-stage biotechnology company focused on targeted therapies for patients with severe immune-mediated diseases (IMDs), today announced the companies have entered into a definitive agreement under which Biogen has agreed to acquire HI-Bio for $1.15 billion upfront and up to $650 million in potential milestone payments.

CAMBRIDGE, Mass. and CARLSBAD, Calif., May 16, 2024 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) and Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) announced the decision to terminate development of BIIB105 (ION541) an investigational antisense oligonucleotide (ASO) for amyotrophic lateral sclerosis (ALS) based on topline results from the Phase 1/2 ALSpire study. BIIB105 was designed to reduce expression of ataxin-2 (ATXN2) protein and demonstrated statistically significant cerebrospinal fluid (CSF) ATXN2 protein reductions in the study. However, over the 6-month placebo-controlled period, treatment with BIIB105 did not result in a reduction in levels of plasma neurofilament light chain (NfL), a marker of neurodegeneration and neuronal damage. Additionally, BIIB105 did not demonstrate an impact on clinical outcome measures of function, breathing, and strength.

TOKYO and CAMBRIDGE, Mass., May 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 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. brand name: LEQEMBI®) subcutaneous autoinjector for weekly maintenance dosing after it was granted Fast Track designation by the FDA. LEQEMBI is indicated for the treatment of Alzheimer’s disease (AD) in patients with Mild Cognitive Impairment (MCI) or mild dementia stage of disease (collectively referred to as early AD).

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.

CAMBRIDGE, Mass., March 06, 2024 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) announced interim 6-month biomarker data from the initial 29 participants in the open-label RESPOND study.* The Phase 4 study evaluates clinical outcomes and safety following treatment with SPINRAZA over a 2-year period in infants and toddlers with spinal muscular atrophy (SMA) who have unmet clinical needs after treatment with Zolgensma® (onasemnogene abeparvovec). The new data show that plasma neurofilament light chain (NfL) levels, an objective biomarker of axonal injury and neurodegeneration, were reduced in nearly all study participants treated with SPINRAZA. These data will be presented at the 2024 Muscular Dystrophy Association (MDA) Clinical & Scientific Conference (March 3-6, 2024).

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 5-9 in Lisbon, Portugal and virtually. The presentations include new data for its oral small molecule inhibitor of tau aggregation (BIIB113), as well as presentations providing insights into the underlying mechanisms of Alzheimer’s disease.

CAMBRIDGE, Mass., Feb. 23, 2024 (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 a marketing authorization under exceptional circumstances for QALSODY® (tofersen) for the treatment of adults with amyotrophic lateral sclerosis (ALS), associated with a mutation in the superoxide dismutase 1 (SOD1) gene. If authorized by the European Commission (EC), QALSODY will be the first treatment approved in the European Union to target a genetic cause of ALS, also known as motor neuron disease (MND).

CAMBRIDGE, Mass., Feb. 12, 2024 (GLOBE NEWSWIRE) --  Biogen Inc. (Nasdaq: BIIB) announced the European Commission (EC) has authorized SKYCLARYS® (omaveloxolone) for the treatment of Friedreich’s ataxia (FA) in adults and adolescents aged 16 years and older. SKYCLARYS is the first treatment approved within the European Union for this rare, genetic, progressive neurodegenerative disease.1

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 therapeutic area expected to drive near and long-term growth. The company will continue to advance LEQEMBI® (lecanemab-irmb), the first anti-amyloid beta treatment with FDA traditional approval in the United States, and will accelerate development of potential new treatment modalities, including its ASO targeting tau (BIIB080) and an oral small molecule inhibitor of tau aggregation (BIIB113). The company will discontinue the development and commercialization of ADUHELM® (aducanumab-avwa) 100 mg/mL injection for intravenous use and will terminate the ENVISION clinical study. This decision is not related to any safety or efficacy concerns. A large portion of the resources released resulting from termination of the ADUHELM program will be redeployed in Biogen’s AD franchise.

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.

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) recommended marketing authorization for SKYCLARYS® (omaveloxolone) for the treatment of Friedreich’s ataxia (FA) in people aged 16 years and older. If approved by the European Commission (EC), SKYCLARYS will be the first treatment authorized within the European Union for this rare, genetic, progressive neuromuscular disease.1 If approved, omaveloxolone will be marketed as SKYCLARYS.

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

Accomplished executive brings deep expertise leading global financial organizations and overseeing successful business transformation

Investigational Subcutaneous Formulation Clears 14% More Plaque Than IV, Pharmacokinetics (AUC) 11% Higher, And Similar ARIA Rates To IV

CAMBRIDGE, Mass., Oct. 25, 2023 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) reported new Phase 1b clinical data from the study of BIIB080, an investigational antisense oligonucleotide (ASO) therapy targeting tau, in mild Alzheimer’s disease (AD). The data showed favorable trends on multiple exploratory endpoints of cognition and activities of daily living in AD (n=46), building upon prior results which showed a reduction of tau protein in the cerebral spinal fluid (CSF t-tau) and tau positron emission tomography (PET) across brain regions. The late-breaking results were presented at the 2023 Clinical Trials on Alzheimer’s Disease (CTAD) meeting held in Boston, MA from October 24-27.

CAMBRIDGE, Mass., Oct. 19, 2023 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) will present new data from its Alzheimer’s disease portfolio at the upcoming Clinical Trials on Alzheimer’s Disease (CTAD) meeting taking place October 24-27 in Boston, Mass. The presentations will advance the understanding of Alzheimer’s disease with data on different treatment approaches, predictive analysis of disease progression, and clinical meaningfulness of amyloid removal for patients and their caregivers.

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) intravenous formulation, a biosimilar monoclonal antibody referencing ACTEMRA. The TOFIDENCE intravenous formulation is approved for the treatment of moderately to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis.

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 inflammation in serious neurologic diseases. As a result of the transaction, Biogen has now acquired SKYCLARYS® (omaveloxolone), as well as other clinical and preclinical pipeline programs.

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 Japan as a treatment for slowing progression of mild cognitive impairment (MCI) and mild dementia due to Alzheimer’s disease (AD).

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.

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

CAMBRIDGE, Mass. and PLANO, Texas, July 28, 2023 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) and Reata Pharmaceuticals, Inc. (Nasdaq: RETA) today announced the companies have entered into a definitive agreement under which Biogen has agreed to acquire Reata for $172.50 per share in cash, reflecting an enterprise value of approximately $7.3 billion.

Further Phase 3 analysis shows benefits of lecanemab on both amyloid-beta and tau, two underlying pathological hallmarks of Alzheimer’s disease

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

CAMBRIDGE, Mass., June 30, 2023 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) announced new SPINRAZA® (nusinersen) data aimed at answering critical questions for the spinal muscular atrophy (SMA) community. The data were presented at the SMA Research & Clinical Care Meeting hosted by Cure SMA this week in Orlando, Fla.

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 their perspective on a range of issues around the company’s performance and strategy.

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

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) protofibril* antibody, for the treatment of early Alzheimer’s disease (mild cognitive impairment due to Alzheimer’s disease (AD) and mild AD dementia) with confirmed amyloid pathology in the brain.

CAMBRIDGE, Mass., April 25, 2023 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) announced today that the U.S. Food and Drug Administration (FDA) has approved QALSODY™ (tofersen) 100 mg/15mL injection for the treatment of amyotrophic lateral sclerosis (ALS) in adults who have a mutation in the superoxide dismutase 1 (SOD1) gene. This indication is approved under accelerated approval based on reduction in plasma neurofilament light chain (NfL) observed in patients treated with QALSODY. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).1 The ongoing Phase 3 ATLAS study of tofersen in people with presymptomatic SOD1-ALS will serve as the confirmatory trial.1

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.

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, and caregiver burden and health-related quality of life (QOL), from the results of Eisai’s Phase 3 Clarity AD study of lecanemab (generic name, U.S. brand name: LEQEMBI™), an anti-amyloid-β (Aβ) protofibril* antibody, at the 2023 International Conference on Alzheimer’s and Parkinson’s Diseases annual meeting AD/PD™.

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 impairment (MCI) due to Alzheimer’s disease (AD) and mild AD (collectively known as early AD), were published in the peer-reviewed journals.

CAMBRIDGE, Mass., March 29, 2023 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) reported new promising Phase 1b clinical data showing that the investigational antisense oligonucleotide (ASO) therapy, BIIB080, reduced soluble tau protein in cerebrospinal fluid (CSF) in a dose-dependent and sustained manner in patients with early-stage Alzheimer’s disease (AD). BIIB080 also reduced aggregated tau pathology, as measured by positron emission tomography (PET) in all brain composites assessed. The primary endpoint of the Phase 1b trial (week 25) and open-label long-term extension study (through week 100) was safety and tolerability, with biomarker data as an exploratory endpoint. The results were presented at the International Conference on Alzheimer’s and Parkinson’s Diseases (AD/PD™ 2023) held in Gothenburg, Sweden from March 28 – April 1.

SOD1-ALS is a rare genetic form of the disease affecting approximately 330 people in the United States

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 protection. With this favorable decision, Biogen believes that TECFIDERA is entitled to regulatory marketing protection in the European Union until at least February 4, 2024. Biogen will seek to enforce this protection and continue to enforce its EP 2 653 873 patent related to TECFIDERA, which expires in 2028.

CAMBRIDGE, Mass., March 08, 2023 (GLOBE NEWSWIRE) -- Biogen Inc. (NASDAQBIIB) 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 reelection to the Board at the Annual Meeting.

Confirmatory Phase 3 Clarity AD data to be evaluated by FDA in determining whether to convert accelerated approval of LEQEMBI to a traditional approval

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 been designated for Priority Review by the National Medical Products Administration (NMPA) in China. The Priority Review and Approval Procedure was implemented by the NMPA with the aim of accelerating research, development and launch of new medicines that have significant clinical value. Under this Procedure, the assessment period is expected to be shortened.

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 the filing of a New Drug Application (NDA) for zuranolone in the treatment of major depressive disorder (MDD) and postpartum depression (PPD). Zuranolone is an investigational drug being evaluated as a 14-day, rapid-acting, once-daily, oral treatment in adults with MDD and PPD. The application has been granted priority review and the FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of August 5, 2023.

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* antibody, in Japan has been designated for Priority Review by the Japanese Ministry of Health, Labour and Welfare (MHLW). Priority Review in Japan is granted to new medicines recognized as having high medical utility for serious diseases, and once designated for Priority Review, the target total review period is shortened.

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 investigational anti-amyloid beta (Aβ) protofibril* antibody, for the treatment of early Alzheimer’s disease (mild cognitive impairment due to Alzheimer’s disease (AD) and mild AD dementia) with confirmed amyloid pathology, for review following a standard timeline.

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.

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 oligonucleotide (ASO) therapies into the intrathecal space. Through this agreement, Biogen aims to leverage the ThecaFlex DRx™ System with a goal of improving the patient treatment experience and accessibility for a broader population of people suffering from neurological disorders, such as spinal muscular atrophy (SMA) and amyotrophic lateral sclerosis (ALS).

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 agreement, Biogen will have no payment obligations and will receive tiered royalties on potential net sales of glofitamab within the United States as part of the companies long-standing collaboration on antibodies targeting CD20.

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.

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 superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS). SOD1-ALS is a progressive and uniformly fatal disease that affects less than 1,000 people in Europe.2 There is currently no treatment targeted for SOD1-ALS.3

Distinguished Industry Leader Brings Extensive International Experience in Large Pharmaceutical and Entrepreneurial Biotech Companies

CAMBRIDGE, Mass., Oct. 26, 2022 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) announced new data on multiple sclerosis (MS) disease measurement and advanced analytics being presented at the 38th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) meeting October 26-28, 2022. These data highlight Biogen’s multi-pronged approach to pursue MS-related digital health research aimed at supporting the development of new treatments, individualizing care, and advancing the understanding of disease heterogeneity.

CAMBRIDGE, Mass., Oct. 26, 2022 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) announced new data from its industry-leading portfolio of multiple sclerosis (MS) therapies being presented at the 38th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) meeting October 26-28, 2022. The presentations include the final safety and efficacy results of the VUMERITY® (diroximel fumarate) EVOLVE-MS-1 study, as well as a matching analysis comparing treatment with VUMERITY to Ponvory® (ponesimod) and Aubagio® (teriflunomide); patient-reported outcomes and an analysis of the proprietary StratifyJCV™ assay for TYSABRI® (natalizumab); a study evaluating treatment with TECFIDERA® (dimethyl fumarate) to prevent first clinical manifestation of MS for people with radiologically isolated syndrome; and studies assessing the impact of PLEGRIDY® (peginterferon beta-1a) and AVONEX® (interferon beta-1a) on pregnancy, breastfeeding and child development.