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Sirnaomics Ltd Granted FDA Approval for Phase I RSV mRNA Vaccine Study
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Sirnaomics Ltd (HKG: 2257) has received approval from the US Food and Drug Administration (FDA) to conduct a Phase I clinical study for its mRNA vaccine candidate RV-1770, targeting the respiratory syncytial virus (RSV) to prevent infections in adults. The study will involve the administration of three different doses (50mg,…
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Roche Receives NMPA Approval for Ophthalmology BsAb Vabysmo (Farcimab) for Diabetic Macular Edema
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Swiss pharmaceutical giant Roche (SWX: ROG) has announced that it has obtained marketing approval from China’s National Medical Products Administration (NMPA) for its ophthalmology bispecific antibody (BsAb) Vabysmo (faricimab), which is indicated for the treatment of diabetic macular edema (DME). Vabysmo targets both vascular endothelial growth factor A (VEGF-A) and…
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Huadong Medicine Gets NMPA Green Light for Clinical Study of Ryzodeg Biosimilar
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its biosimilar version of Novo Nordisk’s (NYSE: NVO) Ryzodeg (insulin degludec, insulin aspart), intended for the treatment of adults with type 2 diabetes.…
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Fosun Pharmaceutical Secures GHIT Fund Investment for Malaria Drug Trial
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Shanghai Fosun Pharmaceutical Co., Ltd (SHA: 600196, HKG: 2196) has received financial backing of JPY 500 million (USD 3.3 million) from the Japan-based Global Health Innovative Technology (GHIT) Fund for a Phase III trial of a triple artemisinin combination drug aimed at treating malaria. Fosun Pharmaceutical is developing a fixed-dose…
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FDA Approves Pfizer-Astellas-MSD Combo Therapy for Advanced Urothelial Cancer
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Pfizer (NYSE: PFE), Astellas (TYO: 4503), and Merck, Sharp & Dohme (MSD; NYSE: MRK) have secured U.S. Food and Drug Administration (FDA) approval for their combination therapy consisting of Padcev (enfortumab vedotin) and Keytruda (pembrolizumab) for the treatment of locally advanced or metastatic urothelial cancer (la/mUC). The FDA’s decision is…
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China Releases Emergency Use Rules for Medical Devices Amid Public Health Emergencies
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The National Medical Products Administration (NMPA), National Health Commission (NHC), and Chinese Center for Disease Control and Prevention (CDC) have jointly issued the “Medical Device Emergency Use Management Rules (trial),” which are effective immediately. These rules govern the emergency use of medical devices within a specified scope and period for…
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Novo Nordisk Acquires Alkermes’ Irish Production Site for $92.5 Million to Boost GLP-1 Output
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Novo Nordisk (CPH: NOVO-B), a Danish pharmaceutical giant, has reached an agreement to acquire a production facility in Ireland from Alkermes (NASDAQ: ALKS), a drug manufacturer, along with related assets for a total consideration of USD 92.5 million. The transaction, which is subject to customary adjustments and fulfillment of closing…
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Reetoo Biotechnology Boosts AI in Medical Diagnostics with $14 Million Funding Round
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Shenzhen Reetoo Biotechnology Co., Ltd, a Chinese firm at the forefront of integrating artificial intelligence with medical diagnostics, has reportedly secured over RMB 100 million (USD 14 million) in a Series B2 financing round. The round was led by CAS Investment and a prominent Chinese fund, with additional participation from…
