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UCB and Biogen’s Dapirolizumab Pegol Shows Promise in Phase III SLE Study
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Partners UCB (FRA: UNC) and Biogen Inc. (NASDAQ: BIIB) have announced positive results from a Phase III study of their co-developed drug candidate, dapirolizumab pegol (DZP), a novel Fc-free anti-CD40L agent, when combined with the standard-of-care (SOC) in patients with moderate-to-severe systemic lupus erythematosus (SLE). The findings, which indicate a…
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Biogen and Samsung Bioepis Win EC Approval for Opuviz Biosimilar in Europe
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US-based Biogen Inc. (NASDAQ: BIIB) and South Korea’s Samsung Bioepis Co., Ltd. have jointly announced that they have received marketing approval from the European Commission (EC) for their Opuviz 40 mg/mL solution for injection in a vial. This biosimilar product, a version of Bayer/Regeneron’s Eylea (aflibercept), is now approved for…
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Eisai and Biogen’s Lecanemab Receives Positive CHMP Opinion for Early Alzheimer’s Treatment
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Eisai Co., Ltd (TYO: 4523) and Biogen Inc. (NASDAQ: BIIB) have jointly announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of lecanemab, an amyloid-beta (Aβ) monoclonal antibody, for the treatment of adult patients…
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Eisai and GE Healthcare Sign MoU at CIIE to Collaborate on Alzheimer’s Disease Solutions
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At the 7th China International Import Expo (CIIE), Japan-based Eisai Co., Ltd (TYO: 4523) entered into a Memorandum of Understanding (MoU) with US medical device and life sciences giant GE Healthcare Technologies Inc. (NASDAQ: GEHC). The partnership, centered on the early detection, precise diagnosis, and treatment of Alzheimer’s disease (AD),…
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Eisai and Biogen Complete BLA Submission for Alzheimer’s Drug Leqembi to FDA
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Eisai Co., Ltd (TYO: 4523) and Biogen Inc. (NASDAQ: BIIB) have jointly announced the completion of a rolling submission of a Biologics License Application (BLA) for their co-developed Alzheimer’s disease drug Leqembi (lecanemab) to the U.S. Food and Drug Administration (FDA). The submission seeks approval for Leqembi as a subcutaneous…
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Biogen Reports Q3 2024 Sales Dip, Raises Full-Year Guidance
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US biotechnology company Biogen Inc. (NASDAQ: BIIB) reported global sales of USD 2.466 billion for the third quarter of 2024, marking a 3% year-on-year (YOY) decrease in operational terms. Despite this, Biogen increased its full-year 2024 financial guidance, with non-GAAP diluted EPS now expected to range between USD 16.10 and…
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Biogen Partners with Neomorph to Develop Molecular Glue Degraders for Alzheimer’s and Rare Diseases
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U.S.-based Biogen Inc. (NASDAQ: BIIB) has announced a research collaboration with Neomorph to jointly develop molecular glue degraders targeting key areas in Alzheimer’s, rare neurological disorders, and immunological diseases. Leveraging Neomorph’s proprietary molecular glue discovery platform, the partnership aims to enhance the identification and validation of novel small-molecule therapeutic degraders…
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Biogen’s Felzartamab Demonstrates Promising Results in Phase II Study for IgA Nephropathy
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Biogen Inc. (NASDAQ: BIIB), a prominent biopharmaceutical company based in the U.S., has announced comprehensive results from the Phase II IGNAZ study for felzartamab in the treatment of IgA nephropathy. The findings were showcased at Kidney Week 2024, the annual meeting of the American Society of Nephrology. The study demonstrated…
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Leqembi, Alzheimer’s Drug by Eisai and Biogen, Now Covered by Qihuibao Insurance in China
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Leqembi (lecanemab), an Alzheimer’s disease treatment co-developed by Eisai Co., Ltd (TYO: 4523) and Biogen Inc. (NASDAQ: BIIB), has been included in the coverage scope of “Qihuibao,” a commercial supplementary health insurance program in Zibo city, Shandong province, China. The drug received approval in China in January of this year…
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Biogen Gains FDA Breakthrough Status for Felzartamab in Kidney Transplant Rejection Treatment
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Biogen Inc. (NASDAQ: BIIB) has secured breakthrough therapy designation (BTD) from the U.S. Food and Drug Administration (FDA) for felzartamab, an investigational anti-CD38 monoclonal antibody aimed at treating late antibody-mediated rejection (AMR) without T-cell mediated rejection in kidney transplant patients. This designation is pivotal as AMR is a leading cause…
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Biogen’s China Unit Gets Conditional NMPA Nod for Qalsody (Tofersen) in ALS Treatment
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Biogen (NASDAQ: BIIB)’s Chinese subsidiary has announced that it has received conditional approval from the National Medical Products Administration (NMPA) for its drug Qalsody (tofersen) for the treatment of adult patients with amyotrophic lateral sclerosis (ALS) who have a superoxide dismutase 1 (SOD1) gene mutation. ALS is a rare disease,…
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UK MHRA Approves Eisai and Biogen’s Alzheimer’s Drug Leqembi, Despite NICE Reimbursement Rejection
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The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted approval for Leqembi (lecanemab), a co-developed Alzheimer’s disease drug by Eisai Co., Ltd (TYO: 4523) and Biogen Inc. (NASDAQ: BIIB). This development, however, was met with a refusal from the National Institute for Health and Clinical Excellence (NICE), the…
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Biogen and Eisai Secure UAE Approval for Alzheimer’s Therapy Leqembi
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Biogen Inc. (NASDAQ: BIIB), based in the U.S., and Japan’s Eisai Co., Ltd. have announced that their Alzheimer’s disease therapy, Leqembi (lecanemab), has received approval in the United Arab Emirates (UAE) for the treatment of patients with mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) and/or mild AD dementia.…
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EU Regulator Rejects Marketing Authorization for Biogen and Eisai’s Alzheimer’s Drug Leqembi
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Biogen Inc. (NASDAQ: BIIB), a US biotechnology company, and its Japanese counterpart Eisai Co., Ltd have encountered a setback in their efforts to secure European approval for Leqembi (lecanemab), an Alzheimer’s disease therapy. The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a negative…
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Eisai and Biogen’s Alzheimer’s Therapy Leqembi Receives Marketing Approval in Hong Kong
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Eisai Co., Ltd, a Japanese pharmaceutical company, along with its co-development partner Biogen Inc. (NASDAQ: BIIB), has announced that they have received marketing approval in Hong Kong for their Alzheimer’s disease (AD) therapy Leqembi (lecanemab). Known as 乐意保 in Chinese, the drug is administered intravenously every two weeks and is…
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Eisai and Biogen Launch Alzheimer’s Drug Leqembi in China Following Market Approval
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Eisai Co., Ltd (TYO: 4523), a Japanese pharmaceutical company, in partnership with Biogen Inc. (NASDAQ: BIIB), has announced the official market launch of Leqembi (lecanemab), a therapy for Alzheimer’s disease (AD), in China. This follows the drug’s official market approval in China in January this year. Leqembi is a humanized…
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Bio-Thera Solutions’ BAT1806 Receives Positive CHMP Recommendation for EU Approval
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China-based Bio-Thera Solutions Ltd (SHA: 688177) has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for the market approval filing of BAT1806, a biosimilar version of Roche Holding AG’s (SWX: ROG) Actemra/RoActemra (tocilizumab). The CHMP’s recommendation…
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Biogen Appoints Ding Weibo as Head of Asia-Pacific Region, Succeeding Francis Wan
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Biogen (NASDAQ: BIIB) has announced the appointment of Ding Weibo as the new head of its Asia-Pacific region, reporting directly to Fraser Hall, the head of Biogen’s Intercontinental Market. Ding succeeds Francis Wan in this pivotal role. Ding Weibo brings a wealth of experience from his tenure at several multinational…
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Biogen Discontinues Aduhelm Development, Redirects Focus to Other Alzheimer’s Therapies
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Biogen (NASDAQ: BIIB) has announced its decision to discontinue the development and commercialization of its Alzheimer’s disease (AD) drug Aduhelm (aducanumab), including a Phase IV post-marketing confirmatory study that was necessary to upgrade the treatment’s accelerated approval in the US. This move will incur USD 60 million in close-out costs…
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Sandoz Launches Biosimilar Natalizumab in Germany, Challenging Biogen’s Tysabri
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Sandoz, a division of Novartis and a leader in generic drugs and biosimilars headquartered in Switzerland (SWX: SDZ), has announced the launch of Tyruko (natalizumab), the first biosimilar version of Biogen’s (NASDAQ: BIIB) blockbuster Tysabri, in the German market. This move marks a significant advancement in the treatment options for…
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Ji Xing Pharmaceuticals Secures Licensing Rights for Biogen’s BIIB131 in Stroke Treatment
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Shanghai-based Ji Xing Pharmaceuticals, supported by RTW Investments, has secured a licensing agreement with Biogen (NASDAQ: BIIB) for the global clinical development rights to the US company’s pipeline candidate BIIB131. The terms of the deal include an undisclosed upfront payment, milestone payments, and royalties on future global sales. BIIB131 is…
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C4 Therapeutics Outlines 2024 Focus Amid 30% Workforce Reduction, Prioritizes Key Oncology Trials
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C4 Therapeutics (NASDAQ: CCCC), a leader in protein degradation, announced this week its strategic focus for 2024, which includes a significant reduction of 30% in its workforce. The U.S.-based company will prioritize ongoing Phase I/II trials for CFT7455 and CFT1946, targeting relapsed/refractory multiple myeloma (r/rMM) and BRAF V600X-mutant solid tumors,…
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Biogen’s BIIB080 Shows Promise in Phase Ib Trial for Mild Alzheimer’s Disease
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Biogen (NASDAQ: BIIB) has released preliminary findings from a Phase Ib trial for BIIB080, a microtubule-associated protein tau (MAPT)-targeting antisense oligonucleotide (ASO) co-developed with Ionis Pharmaceuticals (NASDAQ: IONS). The trial focused on patients with mild Alzheimer’s disease (AD), showing that high doses of the spinal injection led to improvements in…
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Bio-Thera Solutions’ BAT1806 Receives US FDA Approval as Biosimilar to Actemra/RoActemra
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Bio-Thera Solutions Ltd (SHA: 688177), a China-based biopharmaceutical company, announced that its biosimilar version of Roche Holding AG’s (SWX: ROG) Actemra/RoActemra (tocilizumab), known as BAT1806, has passed review by the US FDA. This milestone marks the approval of BAT1806 for use in the US market to treat a range of…
