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Sino Biopharmaceutical Submits IND Application for AT2R Antagonist TRD205 to FDA
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Sino Biopharmaceutical Ltd (HKG: 1177), a leading China-based biotech company, has announced the filing of an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) for its AT2R antagonist, TRD205. The drug is intended to address neuropathic pain, a common and debilitating chronic condition that significantly…
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Fosun Pharma’s Serplulimab Approved for Esophageal Squamous Cell Carcinoma and Grafalon for GvHD Study
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196) has issued updates on the development statuses of two of its key products. The company’s Programmed-death 1 (PD-1) inhibitor, HaiSiZhuang (serplulimab), has been approved for a new indication in the treatment of first-line PD-L1 positive unresectable locally advanced/recurrent or metastatic esophageal squamous…
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J&J and HHS Expand Public Health Initiative with Asha Therapeutics
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Johnson & Johnson (J&J; NYSE: JNJ) and the US Department of Health and Human Services (HHS) have welcomed biopharmaceutical company Asha Therapeutics into their joint initiative focused on public health preparedness. This collaboration aims to leverage Asha’s proprietary drug discovery platform, which is capable of designing candidates for a wide…
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CDC Provisionally Recommends Pfizer’s Abrysvo for Maternal Immunization Against RSV
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The US Centers for Disease Control and Prevention (CDC) has issued a provisional recommendation for the use of Pfizer’s (NYSE: PFE) bivalent respiratory syncytial virus (RSV) vaccine, Abrysvo, as a seasonal maternal immunization strategy. This measure aims to prevent RSV lower respiratory tract infection in infants, a significant cause of…
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Boehringer Ingelheim and Eli Lilly’s Jardiance Wins FDA Approval for CKD Prevention
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Boehringer Ingelheim (BI) and Eli Lilly (NYSE: LLY) have received regulatory approval from the US Food and Drug Administration (FDA) for their SGLT2 inhibitor, Jardiance (empagliflozin), marking a significant advancement in the treatment of chronic kidney disease (CKD). The drug is now approved for the prevention of kidney function decline,…
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MSD’s Keytruda Meets Endpoints in Urothelial Carcinoma Trial but Misses in NSCLC Study
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Merck, Sharp & Dohme (MSD; NYSE: MRK), a leading global pharmaceutical company, last week released clinical data from separate late-stage studies for its anti-PD-1 biologic, Keytruda (pembrolizumab), in combination with other oncology therapies from different partners. The results presented a mixed picture of success and challenges in the field of…
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Betta Pharmaceuticals’ CFT8919 Accepted for Review by China’s NMPA for EGFR L858R Solid Tumors
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Betta Pharmaceuticals Co., Ltd (SHE: 300558), a China-based pharmaceutical company, has announced that the National Medical Products Administration (NMPA) in China has accepted a clinical trial filing for its Category 1 drug candidate, CFT8919. This development marks a significant step forward in the drug’s journey towards clinical evaluation and potential…
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Simcere Pharmaceutical Reports 25.2% Revenue Growth in 2023 Interim Financials
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China-based Simcere Pharmaceutical Group (HKG: 2096) has released its interim financial report for 2023, revealing a robust performance in the first half of the year. The company reported revenues of RMB 3.379 billion (USD 466 million), reflecting a 25.2% year-on-year (YOY) increase. Notably, sales of innovative drugs accounted for 71%…
