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China’s CDE Expands Market Approval Services with Two New Regional Windows
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The China Center for Drug Evaluation (CDE) has announced the establishment of two additional external acceptance service windows at the National Medical Products Administration (NMPA) subcenters in the Yangtze River Delta and the Greater Bay Area. These service windows will commence operations from December 1, 2023, and will be responsible…
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Sinocelltech’s PD-1 Inhibitor SCT-I10A for HNSCC Accepted for NMPA Review
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Sinocelltech Group Ltd (SHA: 688520), a Chinese biopharmaceutical company, has announced that its market approval filing for the investigational product SCT-I10A, a programmed-death 1 (PD-1) monoclonal antibody (mAb), has been accepted for review by the National Medical Products Administration (NMPA). The filed indication is for the treatment of head and…
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Bosscome Science & Technology Secures Series A Funding for Precision Medical Navigation Systems
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Bosscome Science & Technology, a Chongqing-based developer of integrated optical and magnetic navigation systems, has reportedly secured “tens of millions” of renminbi in a Series A financing round led by Zhongxi Life Investment Partnership and Rayfund Investment. The funds raised will be allocated towards market promotion of its submillimeter level…
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NMPA Approves TINGSN Technology’s Disposable Intracardiac Ultrasound Diagnostic Catheter
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The National Medical Products Administration (NMPA) has granted market approval to TINGSN Technology, a China-based firm, for its disposable intracardiac ultrasound diagnostic catheter. This approval is the 239th for an official innovative medical device by the NMPA. The product comprises a catheter body, an operating handle, and a connector, and…
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Everest Medicines’ Nefecon NDA for IgAN Accepted for Review in South Korea
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Everest Medicines (HKG: 1952), a China-based pharmaceutical company, has announced that the New Drug Application (NDA) for Nefecon (sustained-release budesonide) has been accepted for review by South Korea’s Ministry of Food and Drug Safety (MFDS). The therapy is under consideration for approval as a treatment for primary immunoglobulin A nephropathy…
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ClouDr Partners with Yangtze River Pharmaceutical to Digitize Chronic Disease Marketing
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Hangzhou Kang Ming Information Technology Co., Ltd, trading as “ClouDr” (HKG: 9955), has entered into a partnership with fellow Chinese company Yangtze River Pharmaceutical (Group) Co., Ltd. The collaboration will concentrate on providing digitalized marketing services within specific chronic disease sectors, with both parties looking to expand and deepen their…
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CAR T-Cell Therapy Stocks Plunge as FDA Investigates Cancer Reports Linked to Treatments
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Shares of Chimeric Antigen Receptor (CAR) T cell therapy companies plummeted on November 28, 2023, following an announcement from the U.S. FDA regarding an investigation into reports of patients developing cancer as a potential side effect of their treatments. The FDA’s notice highlighted that both clinical trials and post-market surveillance…
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Pfizer Enters Strategic Alliance with Guangdong Government to Boost Biomedicine R&D
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Pfizer (NYSE: PFE), the US pharmaceutical powerhouse, has signed a strategic memorandum of understanding with the People’s Government of Guangdong Municipality to collaborate on various initiatives within the biomedicine sector. This partnership will focus on research and development innovation, R&D translation, and talent cultivation, with the overarching goal of enhancing…
