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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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Shanghai Pharmaceuticals’ MediTrust Health Partners with Eisai for Comprehensive Patient Services
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Shanghai Pharmaceuticals Holding Co., Ltd’s (HKG: 2607, SHA: 601607) subsidiary, MediTrust Health, which specializes in insurance, financing, and direct-to-patient pharmacy services, has entered into a strategic partnership with Japanese pharmaceutical company Eisai (TYO: 4523). This collaboration grants Eisai access to MediTrust Health’s “One-Code Direct Payment-Diversified Payment Platform,” aiming to establish…
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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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Shanghai Pharmaceutical Co., Ltd Secures Multiple Partnerships at CIIE
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At the 7th China International Import Expo (CIIE), China-based Shanghai Pharmaceutical Co., Ltd (SPH, SHA: 601607, HKG: 2607) announced a series of partnerships with prominent pharmaceutical companies, spanning domestic and international entities. Expanding Collaborations in Pharmaceutical InnovationFrance’s Sanofi (NASDAQ: SNY) has agreed to deepen its existing partnership with SPH, initially…
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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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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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FRα ADC Rina-S by Genmab Enters Late-Stage Clinical Trial Following ProfoundBio Acquisition
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Genmab A/S (NASDAQ: GMAB) has initiated a Phase III clinical trial for its FRα ADC candidate, Rina-S, as registered on ClinicalTrials.gov on October 1, 2024. The trial aims to enroll 530 patients with platinum-resistant advanced ovarian cancer to compare Rina-S head-to-head with chemotherapy, with an anticipated preliminary completion date in…
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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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Eisai and SEED Therapeutics Join Forces on Molecular Glue Degraders for Neurodegeneration and Cancer
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Eisai Co., Ltd (TYO: 4523), a Japanese pharmaceutical company, and SEED Therapeutics Inc., a U.S. biotech firm, have announced their intention to enter into a research collaboration aimed at developing novel molecular glue degraders for neurodegenerative diseases and oncology. Eisai will leverage SEED’s expertise in targeted protein degradation (TPD) to…
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Eisai’s Q1 FY2024 Revenues Reflect Mixed Results with Leqembi Sales Doubling
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Eisai Co., Ltd (TYO: 4523), a prominent Japanese pharmaceutical company, has released its financial results for the three-month first quarter of the fiscal year 2024, concluded on June 30, 2024. The company reported a slight decline of 4% in total revenues year-on-year (YOY), amounting to JPY 189 billion (USD 1.26…
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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 Forges Partnerships with Chinese Firms to Strengthen Alzheimer’s Disease Market Presence
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Eisai Co., Ltd, (TYO: 4523) a Japanese pharmaceutical company, has announced separate strategic partnerships with several Chinese healthcare firms, including iKang Healthcare Group, Zhejiang Dian Diagnostics Co., Ltd (SHE: 300244), V-Medical, Kindstar Global (HKG: 9960), and Ribose. These collaborations are aimed at tapping into the Alzheimer’s disease (AD) market in…
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Eisai Co., Ltd Secures Asia-Pacific Rights for Fungal Drug with Sato Pharma Deal
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Eisai Co., Ltd, (TYO: 4523) a leading Japanese pharmaceutical company, has entered into a strategic licensing agreement with compatriot Sato Pharmaceutical Co., Ltd for the development and commercial rights of the anti-fungal drug fosravuconazole in the Asia and Oceania regions. This deal includes the 10 ASEAN nations, Australia, New Zealand,…
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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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Eslicarbazepine Makes First Appearance in China at Sichuan University’s West China Lecheng Hospital
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Eslicarbazepine, a voltage-gated sodium channel blocker, co-developed by Bial-Portela, Eisai, and Sumitomo Pharma, was first prescribed at the West China Lecheng Hospital of Sichuan University late last month. This epilepsy therapy marks the first special novel drug program implemented through the “first pilot, first trial” policy of the Boao Lecheng…
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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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Eisai to Support Grassroots Healthcare in China with Significant Pariet Donation
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Eisai (TYO: 4523), a leading Japanese pharmaceutical company, has announced its commitment to donate 100,000 boxes of the gastresophageal reflux disease (GERD) medication Pariet (rabeprazole) to the Beijing Health Alliance Charitable Foundation. This initiative is designed to support a new program aimed at enhancing the capabilities of grassroots health care…
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Eisai’s Fycompa Gains New Indication for Generalized Tonic-Clonic Seizures in China
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Eisai Co Ltd (TYO: 4523), a Japanese pharmaceutical company, has announced that its antiepilepsy drug (AED) Fycompa (perampanel) has received a new indication approval from China’s National Medical Products Administration (NMPA). The drug is now approved for use as an additional treatment for adults and children aged 12 and above…
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Eisai Forges Strategic Partnership with China Resource Medicine and China Resources Sanjiu for Pharmaceutical Collaboration
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Japanese pharmaceutical company Eisai (TYO: 4523) has entered into a cooperation agreement with China Resource Medicine Commercial Holdings Ltd. and China Resources Sanjiu Medical & Pharmaceutical Co. Ltd. The partnership aims to expand and unite efforts to carry out in-depth cooperation in traditional medicine, innovative projects, patient management, internet healthcare,…
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FDA Reviews Eisai’s Monthly Maintenance Therapy for Early Alzheimer’s with Leqembi
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Last week, the US Food and Drug Administration (FDA) announced the acceptance of an indication extension filing from Japan’s Eisai (TYO: 4523) for Leqembi (lecanemab), an amyloid-beta (Aβ)-targeting therapy intended as a once-monthly maintenance treatment for early Alzheimer’s disease (AD). Currently, the intravenous therapy has conditional approval in the United…
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FDA Reviews Eisai’s Leqembi for Expanded Use as Monthly Alzheimer’s Therapy
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The US Food and Drug Administration (FDA) has given the green light to review an indication extension filing for Leqembi (lecanemab), an amyloid-beta (Aβ)-targeting therapy developed by Japanese pharmaceutical company Eisai Co., Ltd. (TYO: 4523). Currently, Leqembi has conditional approval in Japan as a bi-weekly treatment for Alzheimer’s disease (AD)…
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Eli Lilly Delays Donanemab Action Date as FDA Calls for Advisory Committee Review
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Eli Lilly (NYSE: LLY) has announced a delay in the action date for its Alzheimer’s disease candidate, donanemab, with the U.S. Food and Drug Administration (FDA) pushing the timeline beyond the fourth quarter of 2024. The delay follows the FDA’s request for an advisory committee meeting to evaluate donanemab’s Phase…
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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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Eisai’s Alzheimer’s Drug Leqembi Earns Marketing Approval in China
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Eisai (TYO: 4523), a leading Japanese pharmaceutical company, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its drug Leqembi (lecanemab), an amyloid-beta (Aβ)-targeting therapy indicated for the treatment of mild cognitive impairment (MCI) and mild dementia due to Alzheimer’s disease (AD). This…
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Eisai and Medivir’s Combo Therapy Advances in Liver Cancer with Positive Trial Results
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Japanese pharmaceutical company Eisai’s (TYO: 4523) kinase inhibitor Lenvima (Lenvatinib), combined with Swedish partner Medivir’s (STO: MVIR) chemotherapy fostroxacitabine bralpamide (fostrox), has demonstrated positive outcomes in an open-label Phase Ib/IIa trial for advanced hepatocellular carcinoma (HCC), Medivir announced. Following last year’s encouraging early data, these results are expected to pave…
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SciClone’s Partner Menarini Files for Elacestrant Approval in Macau for Advanced Breast Cancer
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SciClone Pharmaceuticals Inc. (HKG: 6600) has announced that its Italian partner, Menarini Group, has submitted a pre-licensing application for the import of Orserdu (elacestrant) in Macau, seeking approval for its use in treating advanced or metastatic breast cancer. Elacestrant, a next-generation selective estrogen receptor degrader (SERD) developed by Eisai (TYO:…
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Eisai’s Lemborexant Sleep Aid Lemborexant Filed for NMPA Approval in China
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The China Center for Drug Evaluation (CDE) website has indicated that Japan-based Eisai (TYO: 4523) has filed lemborexant, marketed under the trade name Dayvigo, for approval with the National Medical Products Administration (NMPA) in China. Lemborexant is a dual orexin receptor antagonist that competitively binds to two types of orexin…
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Eisai and BioArctic Set December Launch for Alzheimer’s Drug Leqembi in Japan
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Eisai (TYO: 4523) and BioArctic (STO: BIOA-B) have announced the launch of Leqembi (lecanemab) in the Japanese market on December 20. The amyloid-beta (Aβ)-targeting drug received its second global approval in Japan earlier this year and has been incorporated into the National Health Insurance (NHI) system. Leqembi is indicated for…
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Eli Lilly Partners with Prism BioLab to Discover Peptide-Mimicking Small Molecule Inhibitors
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Eli Lilly and Company (NYSE: LLY) has entered into a partnership with Japan-based biotechnology firm Prism BioLab to discover peptide-mimicking small molecule inhibitors (SMIs) for up to three protein-protein interaction (PPI) targets. Under the agreement, Lilly will be responsible for the clinical development and commercialization of any successful candidates, while…
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MSD to Acquire Caraway Therapeutics for USD 610 Million to Boost Neurodegenerative Disease Portfolio
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced an agreement to purchase Caraway Therapeutics, a US-based pre-clinical company, for a potential total of USD 610 million, which includes upfront and milestone payments. This acquisition will enhance MSD’s portfolio with a range of small-molecule candidates targeting neurodegenerative and rare diseases.…
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Eisai Partners with Shanghai Pharmaceuticals for Alzheimer’s Drug Leqembi in China
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Eisai (TYO: 4523), a Japan-headquartered pharmaceutical company, has entered into a significant partnership with Shanghai Pharmaceuticals (SPH; HKG: 2607; SHA: 601607), a leading China-based pharmaceutical distribution giant, to collaborate on the Alzheimer’s disease (AD) drug Leqembi (lecanemab). The deal is potentially valued at RMB 1.5 billion (USD 205 million) and…
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Japan’s MHLW Approves Eisai and BioArctic’s Leqembi for Alzheimer’s Treatment
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The Ministry of Health, Labour and Welfare (MHLW) in Japan has granted approval to Eisai (TYO: 4523) and BioArctic (STO: BIOA-B) for their amyloid-beta (Aβ)-targeting drug, Leqembi (lecanemab), as a treatment for slowing the progression of mild cognitive impairment (MCI) and mild dementia due to Alzheimer’s disease (AD). This marks…
