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GBA Center of NMPA Launches Filing Guidance for Pharmaceutical Enterprises
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The Guangdong-Hong Kong-Macau Greater Bay Area (GBA) Center for Drug Evaluation and Inspection, under the National Medical Products Administration (NMPA), has announced the commencement of filing guidance services for pharmaceutical R&D entities within the GBA. This initiative aligns with the Drug Registration Regulation, aiming to offer technical guidance, facilitate communication,…
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Keymed Biosciences’ IL-4Rα Monoclonal Antibody for Allergic Rhinitis Accepted by China NMPA
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China-based biopharmaceutical company Keymed Biosciences Inc. (HKG: 2162) has announced that the National Medical Products Administration (NMPA) has accepted for review its market filing for stapokibart (CM310), an IL-4Rα monoclonal antibody (mAb) drug candidate, for the treatment of seasonal allergic rhinitis (SAR). The market filing is supported by a Phase…
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Bristol-Myers Squibb’s Camzyos Approved by China’s NMPA for Hypertrophic Cardiomyopathy Treatment
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Bristol-Myers Squibb (BMS; NYSE: BMY) has received marketing approval from China’s National Medical Products Administration (NMPA) for its innovative drug Camzyos (mavacamten) for the treatment of patients with obstructive hypertrophic cardiomyopathy (HCM) graded as II to III under the New York Heart Association (NYHA) functional classification. The drug is indicated…
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Cutia Therapeutics Submits New Drug Application for Androgenic Alopecia Treatment in Hong Kong
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Cutia Therapeutics (HKG: 2487), a dermatology-focused pharmaceutical company, has announced the submission of a New Drug Application (NDA) for its proprietary CU-40102 (external einasteride spray) for the treatment of androgenic alopecia to the Department of Health of Hong Kong, China. CU-40102 is positioned as the world’s first and currently only…
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Zhejiang Huahai Pharmaceutical Wins IND Approval for Antibody-Drug Conjugate from China’s NMPA
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Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521), a China-based pharmaceutical company, has announced that it has received Investigational New Drug (IND) approval from the National Medical Products Administration (NMPA) for its innovative injectable drug candidate, HB0052. The drug is initially intended for evaluation in patients with general advanced solid tumors.…
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German Study Highlights Potential of Amgen’s Blinatumomab in Treating Rheumatoid Arthritis
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Researchers from Germany’s University of Erlangen-Nuremberg have unveiled promising clinical data on the use of bispecific T cell engagers (BiTes) in combating B-cell mediated autoimmune diseases, such as rheumatoid arthritis (RA). The study, titled “Bispecific T cell engager therapy for refractory rheumatoid arthritis,” published in Nature Medicine in December 2023,…
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U.S. Judge Dismisses Johnson & Johnson and Bristol-Myers Squibb Lawsuits Against Drug-Pricing Provisions in Inflation Reduction Act
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In a recent legal development, a U.S. federal court judge has rejected the legal challenges brought by pharmaceutical giants Johnson & Johnson (J&J; NYSE: JNJ) and Bristol-Myers Squibb (BMS; NYSE: BMY) against the drug-price negotiations outlined in President Joe Biden’s Inflation Reduction Act (IRA). The companies had filed separate lawsuits…
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Sino Biological Inc. to Acquire Canadian Bioactive Enzyme Manufacturer SignalChem Biotech
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Sino Biological Inc. (SHE: 301047), a leading provider of biological research reagents and technical contract research services based in China, has entered into a definitive Share Purchase Agreement to acquire SignalChem Biotech Inc. (SCB), a Vancouver, Canada-based manufacturer of specialized bioactive enzymes. The transaction values 100% of SCB’s shares at…
