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NMPA Grants Marketing Approval for Hui Sheng Bio-pharmaceutical’s Janagliflozin
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The National Medical Products Administration (NMPA) has granted marketing approval for Hui Sheng Bio-pharmaceutical Co., Ltd’s Category 1 drug janagliflozin, which is indicated for the control of blood sugar levels in adults with type 2 diabetes. The drug can be used as a monotherapy or in combination with metformin. Janagliflozin,…
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Novartis Lutathera Combo Therapy Shows Significant Progress in GEP-NETs
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has announced preliminary results from a Phase III study that evaluated the efficacy of radioligand therapy (RLT) Lutathera (lutetium (177Lu) oxodotreotide) in combination with the symptom-control drug octreotide as a first-line therapy for SSTR+ well-differentiated grade 2/3 advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The clinical…
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AstraZeneca’s Imfinzi Meets Primary Endpoint in Hepatocellular Carcinoma Trial
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UK pharmaceutical company AstraZeneca (AZ; NASDAQ: AZN) announced the successful completion of the primary endpoint in a Phase III trial for its anti-PD-L1 drug Imfinzi (durvalumab). The trial investigated the combination of Imfinzi with bevacizumab, originally developed by Roche (SWX: ROG) as Avastin, and transarterial chemoembolization (TACE) for embolization-eligible hepatocellular…
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J&J’s Balversa Receives Full FDA Approval for Urothelial Carcinoma Treatment
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The US Food and Drug Administration (FDA) has converted the 2019 accelerated approval for Johnson & Johnson’s (J&J; NYSE: JNJ) FGFR kinase inhibitor Balversa (erdafitinib) into a full registration. Balversa is indicated for the treatment of locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 mutations in patients who…
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Shandong Province Launches Initiatives to Accelerate Pharmaceutical Innovation and Growth
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Shandong province has announced a comprehensive set of measures aimed at optimizing review and approval services and fostering high-quality development in the pharmaceutical sector. The initiatives include supporting innovative R&D, providing financial incentives, enhancing inspection and testing capabilities, improving review and approval efficiency, and aiding in product promotion and standards…
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Everest Medicines Projects Sharp Revenue Increase for 2023 on New Product Launches
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Everest Medicines (HKG: 1952), a China-based pharmaceutical company, has announced a preliminary revenue forecast for the fiscal year ending December 31, 2023. The company expects to report revenues within the range of RMB 124-126 million (USD 17.2-17.5 million), a significant increase compared to the RMB 12.8 million (USD 1.78 million)…
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Uni-Bio Science Group Wins NMPA Nod for Generic Forteo Injection for Osteoporosis
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Hong Kong-listed biopharmaceutical company Uni-Bio Science Group Ltd (HKG: 0690) has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its generic version of Eli Lilly Inc (NYSE: LLY)’s Forteo (teriparatide) injection, indicated for the treatment of osteoporosis in postmenopausal women who are at…
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Endoso Life Raises Over $14 Million in Series A to Expand Endoscope Product Lines
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Endoso Life, a developer of high-end medical endoscope systems headquartered in Hangzhou, has reportedly secured more than RMB 100 million (USD 14 million) in a Series A financing round. The round was led by WEGO’s fund, with additional investment from Lapam Capital. The funds raised will be directed towards expanding…
