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Biogen's Lupus Candidate Meets Key Goals in Phase III Study
ZACKS· 2024-09-25 17:01
Biogen Inc. (BIIB) , along with its Belgian partner UCB, announced positive topline data from the phase III PHOENYCS GO study, which evaluated the investigational drug candidate, dapirolizumab pegol, for the treatment of moderate-to-severe systemic lupus erythematosus (SLE).SLE is a chronic and debilitating autoimmune disease that can affect multiple organ systems.The study met the primary endpoint by demonstrating clinical improvement in moderate-to-severe SLE.Year to date, shares of Biogen have plunged 25 ...
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
GlobeNewswire News Room· 2024-09-24 05:00
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.SLE is a chronic, debilitating autoimmune disease that affects multiple organ systems ...
Samsung Bioepis and Biogen Receive Positive CHMP Opinion for Aflibercept Biosimilar, OPUVIZ™
GlobeNewswire News Room· 2024-09-20 12:00
OPUVIZ™, a biosimilar referencing Eylea1 (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 for Human Use (CHMP) has adopted a positive opinion for OPUVIZ™ 40 mg/mL solution for ...
Biogen Inc. (BIIB) Cantor Fitzgerald Global Healthcare Conference (Transcript)
2024-09-18 19:36
Biogen Inc. (NASDAQ:BIIB) Cantor Fitzgerald Global Healthcare Conference Call September 18, 2024 1:20 PM ET Company Participants Chuck Triano - Head, Investor Relations Conference Call Participants Eric Schmidt - Cantor Fitzgerald Eric Schmidt Good afternoon, everyone. If you could take a seat? My name is Eric Schmidt, and my pleasure to host this next fireside chat with Biogen. We're delighted to have with us today Chuck Triano, who heads the IR group there at Biogen. Chuck, thank you very much for joining ...
US Rheumatologists Believe Biogen's Litifilimab Is the Leading SLE Pipeline Asset Poised to Offer Improvement Over Benlysta and Saphnelo Based on Clinical Trial Data
GlobeNewswire News Room· 2024-09-12 20:36
EXTON, PA, Sept. 12, 2024 (GLOBE NEWSWIRE) -- The systemic lupus erythematosus (SLE) advanced treatment landscape is poised for evolution, with multiple new therapies in development to treat this debilitating and chronic disease. While Biogen’s litifilimab has shown promise in its Phase II clinical trial, other contenders such as AbbVie’s Rinvoq (upadacitinib) and Bristol Myers Squibb’s Sotyktu (deucravacitinib) could further broaden the options in rheumatologists’ treatment armamentarium. The recent quarte ...
Biogen Board Appoints Two New Independent Directors
GlobeNewswire News Room· 2024-09-12 11:30
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 University, and Prof Sir Pangalos was most recently Executive Vice President of Bio ...
Bio-Thera Solutions and Biogen Publish Phase 3 Clinical Trial Data for TOFIDENCE™ (BAT1806/BIIB800), an approved Biosimilar referencing tocilizumab in Arthritis Research & Therapy
Prnewswire· 2024-09-11 12:00
Comparable clinical efficacy and safety in Treatment Period 2 (TP2, Week 24-48) is maintained after switch from reference tocilizumab to TOFIDENCE (BAT1806/BIIB800)Phase 3 clinical data in totality demonstrates biosimilarity between TOFIDENCE (BAT1806/BIIB800) and reference tocilizumab before and after switching.1,2GUANGZHOU, China, Sept. 11, 2024 /PRNewswire/ -- Bio-Thera Solutions, Ltd. today announced, in collaboration with Biogen, the publication in the journal Arthritis Research & Therapy of results fr ...
Alzheimer's drug Leqembi promises to give patients more time, but they face a long road to treatment
CNBC· 2024-09-08 12:00
In this articleESALY4523.T-JPBIIBHannah Yoon | The Washington Post | Getty ImagesLeqembi, an Alzheimer's drug from Biogen and Eisai, isn't a cure for the mind-damaging disease. But the treatment promises to give patients such as Missie Meeks more time to live their daily lives normally and independently of others.Meeks, an English professor based in Ellisville, Mississippi, was diagnosed with an early stage of Alzheimer's last summer ahead of her 50th birthday. That eventually made her a good fit for Leqemb ...
Biogen's Phase II/III SMA Study for Higher Spinraza Dose Meets Goals
ZACKS· 2024-09-05 16:00
Biogen (BIIB) announced positive initial data from the pivotal cohort (Part B) of its mid to late-stage study evaluating the safety and efficacy of a higher dose regimen of Spinraza (nusinersen) in previously untreated, symptomatic infants with spinal muscular atrophy (SMA).The investigational higher dosing regimen of Spinraza, an antisense oligonucleotide targeting the root cause of SMA, includes two 50 mg doses 14 days apart, and a higher maintenance regimen, 28 mg, every four months. Please note that the ...
Biogen Inc.'s (BIIB) Morgan Stanley's 22nd Annual Global Healthcare Conference Transcript
Seeking Alpha· 2024-09-04 17:57
Biogen Inc. (NASDAQ:BIIB) Morgan Stanley’s 22nd Annual Global Healthcare Conference September 4, 2022 10:00 AM ET Company Participants Mike McDonnell – Chief Financial Officer Priya Singhal – Executive Vice President and Head-Development Conference Call Participants Terence Flynn – Morgan Stanley Terence Flynn Okay, great. I think we're going to get started, but thanks for joining us, everyone. I'm Terence Flynn, the U.S. biopharma analyst at Morgan Stanley. We're very pleased to be hosting Biogen today. Fr ...