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© Globe Newswire
28.11.2025
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Eisai Submits New Drug Application for Subcutaneous Formulation of “LEQEMBI®” for the Treatment of Early Alzheimer’s Disease in Japan
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If approved, lecanemab would be the first and only anti-amyloid treatment in Japan to offer an at-home injection from the initiation of treatment for this progressive, relentless disease If approved, lecanemab would be the first and only anti-amyloid treatment in Japan to offer an at-home injection from the initiation of treatment for this progress...
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25.11.2025
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Eisai Completes Rolling Submission to US FDA for LEQEMBI® IQLIK™ (lecanemab-irmb) Supplemental Biologics License Application as a Subcutaneous Starting Dose for the Treatment of Early Alzheimer’s Disease Under Fast Track Status
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LEQEMBI IQLIK, if approved for initiation dosing, would be the first and only anti-amyloid treatment to offer at-home injection from the start of therapy to help patients and care partners treat this progressive, relentless disease LEQEMBI IQLIK, if approved for initiation dosing, would be the first and only anti-amyloid treatment to offer at-home...
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24.11.2025
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Biogen and Dayra Therapeutics Announce Research Collaboration to Discover and Develop Oral Macrocyclic Peptides for a Range of Immunological Conditions
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CAMBRIDGE, Mass. and TORONTO, Nov. 24, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) and Dayra Therapeutics today announced a research collaboration to discover and develop oral macrocyclic peptides for priority targets in immunological conditions. Macrocyclic peptides have a unique profile with the potential to offer biologic-like efficacy...
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20.10.2025
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© Globe Newswire
20.11.2025
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Biogen to Highlight New Lecanemab Data and Scientific Advances at the 18th Clinical Trials on Alzheimer’s Disease Conference
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CAMBRIDGE, Mass., Nov. 20, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced upcoming scientific presentations at the 18th Clinical Trials on Alzheimer’s Disease (CTAD) Conference, taking place December 1-4 in San Diego. Data on LEQEMBI® (lecanemab-irmb) will include findings on subcutaneous administration for initiation dosing,...
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20.10.2025
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17.11.2025
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Biogen and Stoke Therapeutics Announce Publication of Two-Year Natural History Data Demonstrating the Severity of Dravet Syndrome, Including Frequent Seizures and Significant Cognitive and Behavioral Impairments
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– Despite treatment with standard-of-care anti-seizure medicines, children with Dravet syndrome experienced high seizure burden and plateaued in neurodevelopment, resulting in a widening gap relative to children with typical development –...
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17.11.2025
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High Dose Regimen of Nusinersen Receives Positive CHMP Opinion for the Treatment of Spinal Muscular Atrophy
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CAMBRIDGE, Mass., Nov. 17, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending by consensus the approval of the high dose regimen of nusinersen for the treatment of 5q spinal muscular atrophy (SM...
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14.11.2025
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Biogen Completes Acquisition of Alcyone Therapeutics
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CAMBRIDGE, Mass., Nov. 14, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) has completed the acquisition of Alcyone Therapeutics, a clinical-stage biotechnology company known for its innovative CNS therapy delivery solutions, such as the ThecaFlex DRx™ drug delivery system....
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© Globe Newswire
13.11.2025
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“LEQEMBI®” (lecanemab) IV Maintenance Dosing for the Treatment of Early Alzheimer’s Disease Approved in the United Kingdom
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TOKYO and CAMBRIDGE, Mass., Nov. 13, 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 “LEQ...
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03.11.2025
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Biogen to Highlight Scientific Progress in Rare Kidney Disease at American Society of Nephrology (ASN) Kidney Week 2025
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CAMBRIDGE, Mass., Nov. 03, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) – will present new data from its felzartamab clinical development programs at Kidney Week 2025, the American Society of Nephrology’s (ASN) annual meeting, taking place November 5-9 in Houston, Texas. Felzartamab, an investigational anti-CD38 monoclonal antibody, is cur...
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26.10.2025
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Health Canada Grants Authorization for “LEQEMBI®” (lecanemab) for the Treatment of Early Alzheimer’s Disease
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In Canada, lecanemab is indicated for the treatment of adult patients with a clinical diagnosis of mild cognitive impairment or mild dementia due to Alzheimer’s disease (early AD) who are apolipoprotein E ε4 (ApoE ε4*) non-carriers or heterozygotes and who have confirmed amyloid pathology In Canada, lecanemab is indicated for the treatment of adult...
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24.10.2025
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Biogen Licenses Oral C5aR1 Antagonist from Vanqua Bio to Expand Immunology Portfolio
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CAMBRIDGE, Mass. and CHICAGO, Oct. 24, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) and Vanqua Bio today announced a license agreement granting Biogen exclusive worldwide rights to Vanqua’s preclinical, oral C5aR1 antagonist. This agreement strengthens Biogen’s immunology strategy by advancing a proven immune mechanism with the potential...
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© Globe Newswire
22.10.2025
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Biogen to Present Additional Results from Phase 3 Study of Dapirolizumab Pegol in Systemic Lupus Erythematosus at ACR Convergence 2025
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CAMBRIDGE, Mass., Oct. 22, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced upcoming presentations from studies evaluating dapirolizumab pegol (DZP), a novel Fc-free anti-CD40L drug candidate, in systemic lupus erythematosus (SLE) to be presented at the American College of Rheumatology (ACR) Convergence 2025 (October 24-29) in...
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20.10.2025
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14.10.2025
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LEQEMBI® IQLIK™(lecanemab-irmb) Subcutaneous Autoinjector Named to TIME's "Best Inventions of 2025"
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TOKYO and CAMBRIDGE, Mass., Oct. 13, 2025 /PRNewswire/ -- 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...
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13.10.2025
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LEQEMBI® IQLIK™(lecanemab-irmb) Subcutaneous Autoinjector Named to TIME’s “Best Inventions of 2025”
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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), f...
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© Globe Newswire
09.10.2025
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Biogen and Stoke Therapeutics Present New Data at the 54th Child Neurology Society (CNS) Annual Meeting that Support the Potential of Zorevunersen as a Disease-Modifying Medicine for Dravet Syndrome
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– 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 –...
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06.10.2025
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Eisai and Biogen Announce U.S. Availability of LEQEMBI® IQLIK™ (lecanemab-irmb) Subcutaneous Injection Maintenance Dose for Treatment of Early Alzheimer's Disease
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New LEQEMBI CompanionTM 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 fi...
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© Globe Newswire
06.10.2025
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Eisai and Biogen Announce U.S. Availability of LEQEMBI® IQLIK™ (lecanemab-irmb) Subcutaneous Injection Maintenance Dose for Treatment of Early Alzheimer’s Disease
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New LEQEMBI Companion™ 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...
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© Globe Newswire
28.09.2025
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“LEQEMBI®” (lecanemab) IV Maintenance Dosing for the Treatment of Early Alzheimer’s Disease Approved in China
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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 “LEQ...
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24.09.2025
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LEQEMBI® (Lecanemab) Approved for the Treatment of Alzheimer’s Disease in Australia
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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 hum...
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23.09.2025
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Biogen Provides Regulatory Update on High Dose Regimen of Nusinersen
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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 lett...
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18.09.2025
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Biogen to Acquire Alcyone Therapeutics, Expanding Drug Delivery Solution Portfolio for Key Product and Pipeline Candidates
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CAMBRIDGE, Mass., Sept. 18, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) announced the company has entered into a definitive agreement to acquire Massachusetts-based Alcyone Therapeutics. As part of an existing partnership with Alcyone Therapeutics, the companies are advancing ThecaFlex DRx™, an implantable subcutaneous port and catheter d...
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17.09.2025
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Biogen Receives European Commission Approval for ZURZUVAE® (zuranolone), the First and Only Treatment Approved for Women with Postpartum Depression in Europe
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CAMBRIDGE, Mass., Sept. 17, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) announced that the European Commission (EC) has granted marketing authorization for ZURZUVAE® (zuranolone) to treat post-partum depression (PPD) in adults following childbirth. ZURZUVAE is a once-daily, oral, 14-day treatment which represents a novel therapeutic appr...
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02.09.2025
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Eisai Initiated Rolling Supplemental Biologics License Application to the U.S. FDA for LEQEMBI® IQLIK™ (lecanemab-irmb) as a Subcutaneous Starting Dose for the Treatment of Early Alzheimer’s Disease Under Fast Track Status
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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 LEQEMBI IQLIK, if approved for initiation dosing, would be the first and only anti-amyloid treatment to offer at-home injection f...
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© Globe Newswire
02.09.2025
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Biogen and Stoke Therapeutics Present Data at the 36th International Epilepsy Congress that Support the Potential for Zorevunersen to be the First Disease-Modifying Medicine for Dravet Syndrome
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– 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 –...
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29.08.2025
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FDA Approves LEQEMBI® IQLIK™ (lecanemab-irmb) Subcutaneous Injection for Maintenance Dosing for the Treatment of Early Alzheimer's Disease
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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...
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25.08.2025
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Biogen and Stoke Therapeutics Announce Presentations of Clinical Data from Studies of Zorevunersen for the Potential Treatment of Dravet Syndrome at the 36th International Epilepsy Congress
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– 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 –...
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25.08.2025
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Austria and Germany to become the first markets in the European Union (EU) to launch LEQEMBI® (lecanemab)
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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 i...
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11.08.2025
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Biogen and Stoke Therapeutics Announce First Patient Dosed in Phase 3 EMPEROR Study of Zorevunersen, a Potential Disease-Modifying Treatment for Dravet Syndrome
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– Global, pivotal Phase 3 study will evaluate efficacy and safety of zorevunersen compared to sham over a 52-week treatment period –...
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© Globe Newswire
30.07.2025
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Two-Year Real-World Study of LEQEMBI® in the United States Presented at Alzheimer's Association International Conference (AAIC) 2025
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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...
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30.07.2025
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Early Alzheimer's Patients Continue to Benefit from Four Years of LEQEMBI® (lecanemab-irmb) Therapy New Clinical Data Presented at AAIC
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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,...
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25.07.2025
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ZURZUVAE® (zuranolone) Receives Positive Opinion from CHMP for the Treatment of Women with Postpartum Depression
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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 ch...
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21.07.2025
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Biogen to Highlight Scientific Progress Across Alzheimer’s Disease at the Alzheimer’s Association International Conference 2025
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CAMBRIDGE, Mass., July 21, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced upcoming scientific presentations at the 2025 Alzheimer’s Association International Conference (AAIC), taking place July 27-31 in Toronto, Canada. Data on LEQEMBI® (lecanemab) will include 48-month results from the Clarity AD open-label extension, real-...
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© Globe Newswire
27.06.2025
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New Data for Nusinersen Underscore Biogen’s Commitment to Advancing Clinical Research to Improve Outcomes in SMA
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CAMBRIDGE, Mass., June 27, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced new data that reinforce the clinical impact of nusinersen across a broad spectrum of individuals affected by spinal muscular atrophy (SMA). These latest findings from Part C of the DEVOTE trial evaluating a higher dose regimen of nusinersen and the NURT...
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12.06.2025
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Dapirolizumab Pegol Phase 3 Data in SLE Presented at the Annual European Congress of Rheumatology (EULAR) Show Improvement in Fatigue and Reduction in Disease Activity
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BRUSSELS and CAMBRIDGE, Mass., June 12, 2025 (GLOBE NEWSWIRE) -- UCB (Euronext Brussels: UCB) and Biogen Inc. (NASDAQ: BIIB) today presented additional detailed results from the Phase 3 PHOENYCS GO study evaluating dapirolizumab pegol (DZP), a novel Fc-free anti-CD40L drug candidate. In the study, DZP demonstrated significant clinical improvement...
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15.04.2025
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Leqembi®∇ (lecanemab) is the First Medicine that Slows Progression of Early Alzheimer’s Disease to be Authorized in the European Union
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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...
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© Globe Newswire
31.01.2025
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Update on Regulatory Review of Lecanemab for Early Alzheimer’s Disease in the European Union
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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 Applicat...
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27.01.2025
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FDA Approves LEQEMBI® (lecanemab-irmb) IV Maintenance Dosing for the Treatment of Early Alzheimer's Disease
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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., Lt...
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© Globe Newswire
26.01.2025
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FDA Approves LEQEMBI® (lecanemab-irmb) IV Maintenance Dosing for the Treatment of Early Alzheimer’s Disease
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Once every four weeks maintenance dosing may be easier for patients and care partners to continue treatment...
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14.01.2025
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FDA Accepts LEQEMBI® (lecanemab-irmb) Biologics License Application for Subcutaneous Maintenance Dosing for the Treatment of Early Alzheimer's Disease
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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: Cambridg...
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14.01.2025
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FDA Accepts LEQEMBI® (lecanemab-irmb) Biologics License Application for Subcutaneous Maintenance Dosing for the Treatment of Early Alzheimer’s Disease
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LEQEMBI is the only FDA-approved anti-amyloid therapy that potentially could offer the convenience of a subcutaneous injection with at-home administration option LEQEMBI is the only FDA-approved anti-amyloid therapy that potentially could offer the convenience of a subcutaneous injection with at-home administration option...
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05.12.2024
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"LEQEMBI®" (Lecanemab) Approved for the Treatment of Early Alzheimer's Disease in Mexico
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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 Mexi...
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28.11.2024
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"LEQEMBI®" (Lecanemab) for the Treatment of Alzheimer's Disease Launched in South Korea
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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 "LEQE...
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© Globe Newswire
19.11.2024
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Dapirolizumab Pegol Phase 3 Data Presented at the American College of Rheumatology Shows Significant Reduction in Systemic Lupus Erythematosus Disease Activity
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BRUSSELS, Belgium and CAMBRIDGE, Mass., Nov. 19, 2024 (GLOBE NEWSWIRE) -- UCB (Euronext Brussels: UCB) and Biogen Inc. (NASDAQ: BIIB) 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 activit...
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14.11.2024
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Eisai Receives Positive Opinion from the CHMP in the European Union for Lecanemab in Early Alzheimer's Disease
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TOKYO and CAMBRIDGE, Mass., Nov. 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 a positive opinion has been received from the Committee for Medicinal Products for Hum...
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14.11.2024
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Eisai Receives Positive Opinion from the CHMP in the European Union for Lecanemab in Early Alzheimer’s Disease
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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...
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30.10.2024
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Eisai Presents Data on Benefits of Long-Term Administration of Dual-Acting Lecanemab at the 17th Clinical Trials for Alzheimer’s Disease (CTAD) Conference
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-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-...
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29.10.2024
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Biogen and Neomorph Announce Multi-Target Research Collaboration to Discover and Develop Molecular Glue Degraders for Alzheimer’s, Rare, and Immunological Diseases
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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....
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© Globe Newswire
27.10.2024
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Biogen Presents Positive Results from Phase 2 IGNAZ Study of Felzartamab in IgA Nephropathy at American Society of Nephrology (ASN) Kidney Week 2024
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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 fun...
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© Globe Newswire
24.09.2024
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UCB and Biogen Announce Positive Topline Results From Phase 3 Study of Dapirolizumab Pegol in Systemic Lupus Erythematosus and are Initiating Second Phase 3 Study in 2024
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BRUSSELS and CAMBRIDGE, Mass., Sept. 24, 2024 (GLOBE NEWSWIRE) -- UCB (Euronext Brussels: UCB) and Biogen Inc. (NASDAQ: BIIB) 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 (...
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© PR Newswire
22.08.2024
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Leqembi® (lecanemab) Authorized for Early Alzheimer's Disease in Great Britain
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FOR GLOBAL MEDIA AND JOURNALISTS OUTSIDE THE EMEA REGION
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-carriers1
Great Britain becomes the first country in Europe to authorize...
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© Globe Newswire
30.07.2024
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New Clinical Data Demonstrates Three Years of Continuous Treatment with Dual-Acting LEQEMBI® (lecanemab-irmb) Continues to Significantly Benefit Early Alzheimer’s Disease Patients Presented at The Alzheimer’s Association International Conference (AAIC) 20
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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...
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© Globe Newswire
26.07.2024
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Update on Regulatory Review of Lecanemab for Early Alzheimer’s Disease in the European Union
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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 Med...
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© Globe Newswire
02.07.2024
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Biogen Completes Acquisition of Human Immunology Biosciences
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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)....
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© Globe Newswire
27.06.2024
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“LEQEMBI®” (Lecanemab) for the Treatment of Alzheimer’s Disease Launched in China
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China is the Third Country to Launch LEQEMBI Following the United States and Japan China is the Third Country to Launch LEQEMBI Following the United States and Japan...
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© Globe Newswire
09.06.2024
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FDA Accepts Eisai’s Filing of LEQEMBI® (lecanemab-irmb) Supplemental Biologics License Application for IV Maintenance Dosing for the Treatment of Early Alzheimer’s Disease
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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...
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© Globe Newswire
30.05.2024
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Biogen Receives European Commission Approval for QALSODY® (tofersen), the First Therapy to Treat a Rare, Genetic Form of ALS
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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 su...
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© Globe Newswire
22.05.2024
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Biogen Bolsters Late-Stage Pipeline, Expands Immunology Portfolio with Agreement to Acquire Human Immunology Biosciences
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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 de...
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© Globe Newswire
14.05.2024
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Eisai Initiates Rolling Biologics License Application to US FDA for LEQEMBI® (lecanemab-irmb) for Subcutaneous Maintenance Dosing for the Treatment of Early Alzheimer’s Disease Under the Fast Track Status
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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...
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