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Biogen Initiates TRANSCEND Study for Felzartamab in Late AMR Kidney Transplant Patients
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US-based Biogen Inc. (NASDAQ: BIIB) announced the initiation of the TRANSCEND study, a global Phase III trial evaluating the efficacy and safety of its investigational drug felzartamab compared to placebo in adult kidney transplant recipients with late antibody-mediated rejection (AMR). This marks a significant step forward in addressing a critical…
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Eisai’s Lecanemab Rejected by Australia’s TGA for Early Alzheimer’s Treatment
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Japan-based Eisai Co., Ltd (TYO: 4523) announced that the Therapeutic Goods Administration (TGA) of Australia has refused to approve its lecanemab for the treatment of early Alzheimer’s disease (AD), specifically for mild cognitive impairment due to AD and mild AD dementia. Background and PartnershipsEisai entered into a licensing agreement with…
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Biogen Licenses Stoke Therapeutics’ Zorevunersen for Dravet Syndrome Outside Americas
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US-based Biogen Inc. (NASDAQ: BIIB) has entered into a licensing agreement with Stoke Therapeutics, Inc. (NASDAQ: STOK), securing exclusive commercialization rights to zorevunersen, a drug for Dravet syndrome, in all territories outside the United States, Canada, and Mexico. Drug ProfileZorevunersen is an antisense oligonucleotide (ASO) targeting the SCN1A gene, the…
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FDA Clears sBLA for Eisai and Biogen’s Leqembi Maintenance Dosing
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Partners Eisai Co., Ltd (TYO: 4523) and Biogen Inc. (NASDAQ: BIIB) have announced that the US Food and Drug Administration (FDA) has cleared their supplemental Biologics License Application (sBLA) for once every four weeks Leqembi (lecanemab-irmb) intravenous (IV) maintenance dosing. The drug is approved in the US for the treatment…
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Sinopharm Partners with Biogen for Comprehensive Service Agreement
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China-based Sinopharm Group Co., Ltd (HKG: 1099) has entered into a strategic partnership with US-based biopharmaceutical company Biogen (NASDAQ: BIIB). Under the agreement, Sinopharm will provide Biogen with a comprehensive suite of one-stop services, including import multi-port services, national multi-warehouse channel services, new product introductions, channel access, professional pharmacy integration,…
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Biogen Proposes to Acquire Sage Therapeutics for $469M
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US-based Sage Therapeutics, Inc. (NASDAQ: SAGE) has announced that it received an unsolicited, nonbinding proposal from its partner Biogen Inc. (NASDAQ: BIIB) to acquire all of the outstanding shares of Sage Therapeutics not already owned by Biogen. The proposed acquisition price is USD 7.22 per share. Sage Therapeutics’ Recent PerformanceSage…
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Leqembi Autoinjector Advances with FDA Review for Alzheimer’s Treatment
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Partners Eisai Co., Ltd (TYO: 4523) and Biogen Inc. (NASDAQ: BIIB) have announced that the US Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) for Leqembi (lecanemab) subcutaneous autoinjector (SC-AI) for review. The application seeks approval for the treatment of Alzheimer’s disease (AD) in patients with…
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Eisai and Biogen’s Leqembi Approved in Mexico for Early Alzheimer’s Disease Treatment
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Eisai Co., Ltd (TYO: 4523) and Biogen Inc. (NASDAQ: BIIB) have announced that their co-developed drug, Leqembi (lecanemab), a humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody, has been approved by the Federal Commission for the Protection Against Sanitary Risk (COFEPRIS) in Mexico. This approval marks another milestone in the treatment…
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Eisai and Biogen Launch Alzheimer’s Treatment Leqembi in South Korea
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Partners Eisai Co., Ltd (TYO: 4523) and Biogen Inc. (NASDAQ: BIIB) have jointly announced the commercial launch of their co-developed amyloid-beta (Aβ) monoclonal antibody, Leqembi (lecanemab), in South Korea. The Ministry of Food and Drug Safety (MFDS) had previously approved the drug in May 2024 for the treatment of adult…
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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,…
