GlobeNewswire: Biogen Inc. Contains the last 10 of 236 releaseshttp://www.globenewswire.com/External?Length=42024-03-28T18:08:11ZGlobeNewswirehttp://www.globenewswire.com/External?Length=4newsdesk@globenewswire.com (NewsDesk)https://www.globenewswire.com/news-release/2024/03/06/2841312/0/en/New-Biomarker-Data-Add-Further-Evidence-Supporting-the-Potential-Benefit-of-SPINRAZA-nusinersen-in-Infants-and-Toddlers-with-Unmet-Clinical-Needs-after-Gene-Therapy.html?f=22&fvtc=4&fvtv=48315New Biomarker Data Add Further Evidence Supporting the Potential Benefit of SPINRAZA® (nusinersen) in Infants and Toddlers with Unmet Clinical Needs after Gene Therapy2024-03-06T12:30:51Z<![CDATA[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).]]>https://www.globenewswire.com/news-release/2024/03/04/2839989/0/en/Biogen-Highlights-New-Data-at-the-International-Conference-on-Alzheimer-s-and-Parkinson-s-Diseases-AD-PD-2024-Annual-Meeting.html?f=22&fvtc=4&fvtv=48315Biogen Highlights New Data at the International Conference on Alzheimer’s and Parkinson’s Diseases (AD/PD™) 2024 Annual Meeting2024-03-04T21:15:57Z<![CDATA[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.]]>https://www.globenewswire.com/news-release/2024/02/23/2834389/0/en/Biogen-s-QALSODY-tofersen-the-First-Therapy-to-Treat-Rare-Genetic-Form-of-ALS-Received-Positive-Opinion-from-CHMP.html?f=22&fvtc=4&fvtv=48315Biogen’s QALSODY® (tofersen), the First Therapy to Treat Rare, Genetic Form of ALS, Received Positive Opinion from CHMP2024-02-23T12:00:26Z<![CDATA[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).]]>https://www.globenewswire.com/news-release/2024/02/12/2827864/0/en/Biogen-Received-European-Commission-Approval-for-SKYCLARYS-omaveloxolone-the-First-Therapy-to-Treat-Friedreich-s-Ataxia.html?f=22&fvtc=4&fvtv=48315Biogen Received European Commission Approval for SKYCLARYS® (omaveloxolone), the First Therapy to Treat Friedreich’s Ataxia2024-02-12T21:06:00Z<![CDATA[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]]>https://www.globenewswire.com/news-release/2024/01/31/2821003/0/en/Biogen-to-Realign-Resources-for-Alzheimer-s-Disease-Franchise.html?f=22&fvtc=4&fvtv=48315Biogen to Realign Resources for Alzheimer's Disease Franchise2024-01-31T12:30:00Z<![CDATA[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.]]>https://www.globenewswire.com/news-release/2023/12/19/2798443/0/en/Centralized-Marketing-Authorizations-of-Generic-Versions-of-TECFIDERA-are-Revoked-by-the-European-Commission.html?f=22&fvtc=4&fvtv=48315Centralized Marketing Authorizations of Generic Versions of TECFIDERA® are Revoked by the European Commission2023-12-19T12:30:21Z<![CDATA[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.]]>https://www.globenewswire.com/news-release/2023/12/15/2797103/0/en/CHMP-Issues-Positive-Opinion-for-Biogen-s-SKYCLARYS-omaveloxolone-the-First-Therapy-to-Treat-Friedreich-s-Ataxia-a-Rare-Neurodegenerative-Disease.html?f=22&fvtc=4&fvtv=48315CHMP Issues Positive Opinion for Biogen’s SKYCLARYS® (omaveloxolone), the First Therapy to Treat Friedreich’s Ataxia, a Rare Neurodegenerative Disease2023-12-15T14:05:25Z<![CDATA[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.]]>https://www.globenewswire.com/news-release/2023/12/14/2796102/0/en/ZURZUVAE-zuranolone-CIV-a-Landmark-Oral-Treatment-for-Women-with-Postpartum-Depression-PPD-is-Now-Available-in-the-U-S.html?f=22&fvtc=4&fvtv=48315ZURZUVAE™ (zuranolone) CIV, a Landmark Oral Treatment for Women with Postpartum Depression (PPD), is Now Available in the U.S.2023-12-14T11:30:00Z<![CDATA[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]]>https://www.globenewswire.com/news-release/2023/11/06/2773981/0/en/Biogen-Appoints-Monish-Patolawala-to-its-Board-of-Directors.html?f=22&fvtc=4&fvtv=48315Biogen Appoints Monish Patolawala to its Board of Directors2023-11-06T12:30:00Z<![CDATA[Accomplished executive brings deep expertise leading global financial organizations and overseeing successful business transformation Accomplished executive brings deep expertise leading global financial organizations and overseeing successful business transformation]]>https://www.globenewswire.com/news-release/2023/10/25/2767024/0/en/Eisai-Presents-New-LEQEMBI-lecanemab-irmb-Investigational-Subcutaneous-Formulation-Interim-Study-Results-and-Clinical-Improvement-Data-in-Earlier-Stages-of-Early-Alzheimer-s-Diseas.html?f=22&fvtc=4&fvtv=48315Eisai Presents New LEQEMBI® (lecanemab-irmb) Investigational Subcutaneous Formulation Interim Study Results and Clinical Improvement Data in Earlier Stages of Early Alzheimer’s Disease From Additional Analyses of Clarity AD at The Clinical Trials On Alzheimer’s Disease (CTAD) Conference2023-10-25T21:26:00Z<![CDATA[Investigational Subcutaneous Formulation Clears 14% More Plaque Than IV, Pharmacokinetics (AUC) 11% Higher, And Similar ARIA Rates To IV]]>