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Biogen Inc. develops and commercializes biopharmaceutical therapies focused on neurodegenerative diseases, rare diseases and adjacent specialty areas. Company news commonly covers Alzheimer’s disease therapy LEQEMBI with Eisai, spinal muscular atrophy treatment SPINRAZA, Friedreich’s ataxia therapy SKYCLARYS, postpartum depression therapy ZURZUVAE, ALS therapy QALSODY, multiple sclerosis products and CD20 collaboration revenue tied to Roche-partnered medicines.
Recurring updates include FDA review activity, supplemental biologics license applications, global regulatory status, clinical development programs, collaboration and licensing economics, asset-rights transactions and product demand trends. Biogen news also includes financial results, acquired in-process research and development expense, governance changes and corporate-status disclosures typical of a Nasdaq-listed biotechnology issuer.
Biogen (Nasdaq: BIIB) has announced a collaboration with TheraPanacea to utilize machine learning and artificial intelligence in neurology. This partnership aims to enhance patient care, streamline drug development, and deepen understanding of neurological diseases. Biogen will invest up to $15 million and can earn up to $41 million in milestone payments based on R&D achievements. The collaboration grants Biogen exclusive rights to TheraPanacea's technology in neuroscience, promoting a new era in personalized medicine.
Sage Therapeutics and Biogen announced promising results from their clinical program for zuranolone, an investigational treatment for major depressive disorder (MDD). In the WATERFALL Study, patients receiving 50 mg zuranolone showed rapid improvements in depressive symptoms as early as Day 3, with effects maintained through Day 42. Safety profiles were consistent with previous studies, showing no increase in adverse events typical of existing antidepressants. Results for older patients (65+) were similarly favorable. These findings were presented at the American College of Neuropsychopharmacology Congress.
Sage Therapeutics and Biogen have announced positive 12-month results for zuranolone 50 mg in the ongoing Phase 3 SHORELINE Study. The study included 199 patients with major depressive disorder (MDD), demonstrating that 74.9% responded to the initial treatment. Zuranolone was well-tolerated, with 68.8% reporting adverse events, mostly mild to moderate. Approximately 80% of responders received just one or two treatment courses over a year, showcasing the drug's potential for quick symptom relief without frequent dosing.
On November 17, 2021, Biogen and Eisai announced a negative trend vote regarding their Marketing Authorization Application for aducanumab (100 mg/mL) for Alzheimer’s treatment by the European Medicines Agency's CHMP. Following an oral explanation, a formal opinion is expected by December 16, 2021. Biogen emphasized its belief in the data supporting aducanumab, citing new Phase 3 findings that suggest it effectively reduces amyloid beta plaques. The drug is already approved in the U.S. under accelerated conditions, pending further confirmatory trials.
Biogen has received marketing authorization from the European Commission for VUMERITY (diroximel fumarate), a next-generation oral treatment for adults with relapsing-remitting multiple sclerosis (MS). The approval builds on Biogen's reputation in MS therapies and follows similar authorizations in the U.S., Great Britain, and Switzerland. Data from Phase 3 trials indicate that VUMERITY has a favorable gastrointestinal tolerability profile, resulting in lower discontinuation rates compared to TECFIDERA. The launch aims to provide patients flexibility in treatment adherence amid the ongoing COVID-19 pandemic.
Biogen (Nasdaq: BIIB) announced that Dr. Alfred Sandrock, Head of Research & Development, will retire on December 31, 2021, after 23 years with the company. He has spearheaded the development of key therapies such as Tysabri, Tecfidera, Spinraza, and Aduhelm. Priya Singhal will serve as interim Head of Research & Development until a permanent successor is found. Biogen's CEO and Board acknowledged Dr. Sandrock's significant contributions, emphasizing his impact on R&D and the company's growth.
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Biogen and Eisai announced significant findings from ADUHELM's Phase 3 trials at the CTAD conference. Analysis of over 7,000 plasma samples revealed that ADUHELM notably lowered plasma p-tau181, a biomarker for tau tangles in Alzheimer's, in a dose- and time-dependent manner compared to placebo. The reduction in p-tau181 correlated with decreased amyloid beta plaque and less cognitive decline, supporting ADUHELM's efficacy. The EMERGE high-dose group showed a 13% decrease in p-tau181, while ENGAGE showed a 16% decrease. These results strengthen the case for ADUHELM as a treatment option in early Alzheimer's disease.
Eisai and Biogen have announced the use of plasma-based biomarkers in their Phase 3 AHEAD 3-45 clinical trial for lecanemab, an investigational treatment for Alzheimer's disease. This innovative approach aims to improve screening efficiency by identifying cognitively unimpaired individuals eligible for PET imaging. Results from 659 participants indicate that the Aβ42/40 ratio accurately predicts PET eligibility (AUC of 0.87). The trial, which began in July 2020, is pivotal for early Alzheimer's research and was presented at the CTAD conference.
Eisai Co., Ltd. and Biogen Inc. presented positive results from sensitivity analyses of lecanemab at the CTAD conference, demonstrating consistent efficacy for patients with early Alzheimer's disease (AD). Lecanemab outperformed placebo in several key assessments including the Alzheimer’s Disease Composite Score (ADCOMS). The Phase 2b trial achieved super-superiority in clinical change and identified an effective dosing strategy. The companies continue to advance lecanemab through ongoing studies, seeking regulatory approval under the FDA's accelerated pathway.