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Sandoz Receives Positive CHMP Review for Trastuzumab Biosimilar in HER2-Positive Cancers
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Sandoz (SWX: SDZ), the generic and biosimilar drug maker set to separate from Novartis (NYSE: NVS) next month, has received a positive review from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for its trastuzumab biosimilar. The biosimilar is intended for use in treating HER2-positive…
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NMPA Drafts Quality Management Norms for Online Medical Device Sales
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The National Medical Products Administration (NMPA) has issued the “Medical Device Online Sales Quality Management Norms (draft proposal)” and is soliciting public feedback until October 14. This document outlines the fundamental requirements for quality management in the online sales process of medical devices, ensuring that the burgeoning e-commerce sector adheres…
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NMPA Seeks Comments on Medical Device Classification Draft Proposal
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The National Medical Products Administration (NMPA) has issued a notification focusing on the definition and classification of medical device products. The draft proposal is open for public comment until October 18, 2023, allowing stakeholders to provide feedback on the regulatory framework. Risk-Based Classification ProcessThe classification of medical devices involves an…
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Gilead’s Kite CAR-T Therapy Yescarta Achieves 71% CMR in Phase II Trial for R/R LBCL Patients
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Gilead’s (NASDAQ: GILD) subsidiary Kite has announced early results from a Phase II trial of its CAR-T therapy, Yescarta (axicabtagene ciloleucel), for patients with relapsed/refractory (R/R) large B-cell lymphoma (LBCL) who are not eligible for high-dose chemotherapy (HDCT) and autologous stem cell transplantation (ASCT). The study achieved a primary endpoint…
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Pharmanovia Bolsters Neurology Portfolio with Acquisition of Sanofi’s CNS Products
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UK-based healthcare company Pharmanovia has announced the expansion of its neurology portfolio through the strategic acquisition of four central nervous system (CNS) products from French pharmaceutical giant Sanofi (NASDAQ: SNY). This move signifies Pharmanovia’s commitment to enhancing its neurology offerings and aligns with Sanofi’s strategy to divest its Consumer Health…
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Tonghua Dongbao Pharmaceuticals Partners with King-Friend Biochemical on Insulin Development
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China-based Tonghua Dongbao Pharmaceuticals (SHA: 600867) has entered into a partnership with fellow Chinese firm Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd (603707.SH). The collaboration focuses on the development and manufacturing of insulin glargine, insulin aspart, and insulin lispro, with the goal of filing for approval with the US FDA. King-Friend…
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EMA’s CHMP Backs Enhertu for Advanced NSCLC with HER2 Mutations
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The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for the use of Enhertu (trastuzumab deruxtecan), an antibody-drug conjugate (ADC) developed by AstraZeneca (AZ; NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568), in the treatment of advanced non-small cell lung…
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BMS Expands Partnership with Samsung Biologics for Oncology Drug Manufacturing
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Global pharmaceutical company Bristol-Myers Squibb (BMS; NYSE: BMY) has announced an expansion of its existing partnership with Samsung Biologics (KRX: 207940) for the production of an unnamed oncology antibody drug. This new agreement signifies a further step in the collaboration between the two companies, focusing on enhancing the manufacturing capabilities…
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