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GC Biopharma Presents Data Showing Higher Thrombotic Risk with Roche’s Hemlibra
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South Korea’s GC Biopharma (KRX: 006280) has presented evidence suggesting that Roche’s (SWX: ROG) hemophilia therapy, Hemlibra (emicizumab), may display a higher proportion of thrombotic adverse events (AEs) compared to coagulation factor VIII replacements. This finding is based on an analysis of US data reported to the FDA Adverse Event…
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Moderna Announces Immunogenicity of Updated COVID-19 Vaccine Against New Variants
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Moderna (NASDAQ: MRNA) has announced preliminary data indicating that an updated version of its SARS-CoV-2 vaccine is immunogenic against the EG.5 and FL.1.5.1 variants, recently renamed Eris and Fornax by the World Health Organization (WHO), with Eris being classified as a variant of interest (VOI). This development marks a significant…
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Tigermed Establishes International Headquarters in Hong Kong to Accelerate Global Expansion
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China-based Contract Research Organization (CRO) Tigermed (SHE: 300347, HKG: 3347) has announced the opening of its international headquarters in Hong Kong, signifying a significant milestone in the company’s efforts to globalize its operations and corporate development. The new international HQ is set to enhance Tigermed’s ability to coordinate and manage…
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NMPA Approves Rapid Medical Ltd’s Intracranial Thrombectomy Stent for Marketing
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The National Medical Products Administration (NMPA) has granted marketing approval to Rapid Medical Ltd for its intracranial thrombectomy stent. This medical device, which comprises a head end, wire mesh, push shaft, control wire, and handle, is equipped with controllable expansion technology that enhances its utility in surgical procedures. Enhanced Surgical…
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Luye Pharma Launches Rykindo in US, a First for Chinese CNS Drug
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China-based Luye Pharma Group (HKG: 2186) has announced the official commercial operation of its Rykindo (risperidone) extended-release injectable suspension in the United States. Developed on Luye Pharma’s microsphere technology platform, Rykindo is administered via intramuscular injection once every two weeks, utilizing long-acting and extended-release microsphere technology to deliver the active…
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CytoMed Therapeutics Partners with CNK Therapeutics for CAR Gene Grafting Technology
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Singapore-based cell therapy developer CytoMed Therapeutics Ltd (NASDAQ: GDTC) has announced the signing of a memorandum of understanding (MoU) with China’s Hangzhou CNK Therapeutics Co., Ltd. The agreement grants CytoMed a license to utilize CNK’s PiggyBac technology, enabling the permanent grafting of the Chimeric Antigen Receptor (CAR) gene into its…
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CSPC Pharmaceutical Group Receives FDA Approval for NBL-028 Bispecific Antibody Clinical Study
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that it has received the green light from the US FDA to conduct a clinical study for its bispecific antibody (BsAb), NBL-028, which targets CLDN6 and CD137. The initial focus of the study will be on advanced tumors with CLDN6 expression,…
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Aurisco Pharmaceutical Passes US FDA cGMP Inspection at Jiangsu Plant
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China-based Aurisco Pharmaceutical (SHA: 605116) has announced the successful completion of a current Good Manufacturing Practice (cGMP) inspection by the US Food and Drug Administration (FDA) at its Active Pharmaceutical Ingredient (API) and finished dosage form (FDF) plant located in Yangzhou, Jiangsu province. The inspection confirmed that the site was…
