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Zelgen Biopharmaceuticals’ rhTSH Achieves Primary Endpoint in Phase III Study
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266), a China-based pharmaceutical company, has announced that its Phase III clinical study for the drug candidate, recombinant human thyroid stimulating hormone for injection (rhTSH), has successfully reached its pre-set primary endpoint. Following this achievement, the company will proceed with a pre-BLA (Biologics License…
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China’s CDE Proposes Removal of Ambroxol Inhalation Solution and Four Other Drugs
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The Center for Drug Evaluation has issued a notification concerning the Chemical Generic Drug Reference Preparation Adjustment List, inviting public feedback on the draft proposal before the deadline of October 7, 2023. The list proposes the removal of Ambroxol inhalable solution and four other varieties, totaling nine specifications. Specific Drugs…
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CSBIO’s Albenatide Shows Positive Results in Two Phase III Diabetes Trials
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Hebei Changshan Biochemical Pharmaceutical Co., Ltd (CSBIO; SHE: 300255) has announced encouraging results from two Phase III clinical studies for its innovative drug candidate, albenatide (CJC-1134-PC). This Category 1 drug is a long-acting glucagon-like peptide-1 receptor agonist (GLP-1RA), modified with Drug Affinity Complex (DAC) technology based on exenatide. CSCJC DM301…
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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…
