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Ascletis Pharma’s ASC40 Earns FDA Breakthrough Therapy Designation for Fibrotic MASH
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China-based Ascletis Pharma Inc. (HKG: 1672) has announced that ASC40 (denifanstat), a fatty acid synthase (FASN) inhibitor co-developed with US partner Sagimet Biosciences Inc. (NASDAQ: SGMT), has received a breakthrough therapy designation (BTD) from the US Food and Drug Administration (FDA). The designation is for the treatment of patients with…
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HitGen Inc. Partners with Ablink Biotech to Develop Antibody-Oligonucleotide Conjugates
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China-based HitGen Inc. (SHA: 688222) has entered into a partnership with compatriot firm Ablink Biotech to integrate their world-leading trillion-level DNA-Encoded Libraries (DELs), a comprehensive small nucleic acid drug discovery and production platform, and a 300 billion-level biopharmaceutical molecule library. The collaboration aims to provide research and development services for…
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Sichuan Biokin’s BL-B01D1 Earns Breakthrough Therapy Designation for Esophageal Cancer from China’s CDE
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506) has announced that its bispecific antibody drug conjugate (ADC), BL-B01D1, has received breakthrough therapy designation (BTD) from the Center for Drug Evaluation (CDE) in China. The designation is for the treatment of patients with recurrent or metastatic esophageal squamous cell carcinoma (ESCC) who…
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Merck’s Keytruda Meets Primary Endpoint in Phase III Study for Head and Neck Cancer
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US pharmaceutical giant Merck & Co., Inc. (MRK, NYSE: MRK) has announced that the Phase III KEYNOTE-689 study for its PD-1 inhibitor Keytruda (pembrolizumab) has met its primary endpoint of event-free survival (EFS) in patients newly diagnosed with stage III or IVA, resected, locally advanced head and neck squamous cell…
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Boehringer Ingelheim’s Survodutide Earns FDA Breakthrough Therapy Designation for MASH Treatment
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German pharmaceutical company Boehringer Ingelheim has received breakthrough therapy designation (BTD) from the US Food and Drug Administration (FDA) for its drug candidate survodutide (BI 456906), a dual glucagon/GLP-1 receptor agonist, for the treatment of non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) in adults with moderate or advanced fibrosis (stages 2 or…
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Eli Lilly Appoints Thomas J. Fuchs as First Chief AI Officer to Lead AI Initiatives
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Eli Lilly and Company (NYSE: LLY) has announced the appointment of Thomas J. Fuchs, Dr.sc., as its first chief AI officer, effective from October 21, 2024. Fuchs will be responsible for providing strategic direction and leadership for AI initiatives across the company, including drug discovery, clinical trials, manufacturing, and commercial…
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Zephyrm Bioscience Limited Files for IPO on Hong Kong Stock Exchange
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China-based Zephyrm Bioscience Limited, a biopharmaceutical company specializing in the development of novel pluripotent stem cell (PSC) derived cell therapies, has filed for an initial public offering (IPO) on the Hong Kong Stock Exchange. Details of the offering have not been disclosed at this stage. Established in 2017, Zephyrm Bio…
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Pfizer Halts Development of Sisunatovir, an RSV Antiviral, After Phase II/III Trials
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U.S. pharmaceutical giant Pfizer (NYSE: PFE) has decided to discontinue the development of sisunatovir, an antiviral drug for respiratory syncytial virus (RSV), following challenges including drug-drug interactions with antacids. The drug had reached the Phase II/III trial stage, and the decision will see two trials discontinued, according to Endpoints News.…
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