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Jiangsu Hengrui’s SHR2554 Gets Priority Review for Lymphoma Treatment, Strengthening Global EZH2 Inhibitor Market
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) is on the brink of a breakthrough in cancer treatment, with its drug SHR2554 receiving priority review status from China’s Center for Drug Evaluation (CDE). This enhancer of zeste homolog 2 (EZH2) inhibitor is set to revolutionize the treatment of patients with recurrent…
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Jiangsu Hengrui Secures FDA Nod for Generic Abraxane, Strengthening Oncology Portfolio
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has achieved a first in the US market with the FDA’s approval of its Abbreviated New Drug Application (ANDA) for a generic version of Abraxis BioScience’s Abraxane (paclitaxel, albumin-bound). This marks a significant milestone for the Chinese pharmaceutical firm, which now leads in…
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Roche’s VENTANA CLDN18 Assay Receives EU Approval, Enhances Targeted Therapy Options for Gastric Cancer
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Roche (SWX: ROG; OTCMKTS: RHHBY) has secured CE Mark approval in the European Union for its VENTANA CLDN18 (43-14A) RxDx Assay, marking a pivotal advancement in the treatment landscape for gastric cancer. This immunohistochemistry (IHC) companion diagnostic (CDx) test is the first to determine CLDN18 protein expression in tumors of…
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Biogen Gains FDA Breakthrough Status for Felzartamab in Kidney Transplant Rejection Treatment
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Biogen Inc. (NASDAQ: BIIB) has secured breakthrough therapy designation (BTD) from the U.S. Food and Drug Administration (FDA) for felzartamab, an investigational anti-CD38 monoclonal antibody aimed at treating late antibody-mediated rejection (AMR) without T-cell mediated rejection in kidney transplant patients. This designation is pivotal as AMR is a leading cause…
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Eli Lilly & Co. Boosts Suzhou Plant with $211M to Meet Diabetes and Obesity Drug Demand
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Eli Lilly & Co.(NYSE: LLY)’s China subsidiary is poised to invest a substantial RMB 1.5 billion (USD 211.95 million) to expand its manufacturing capabilities in Suzhou, a strategic move aimed at augmenting the production of drugs for type 2 diabetes and obesity. This capital expenditure is set to not only…
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China’s NMPA Proposes Rewards for Internal Whistleblowers in Drug and Medical Device Safety Reporting
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The National Medical Products Administration (NMPA) of China has issued a draft proposal for the “Notice on Rewarding Internal Whistleblowers for Reporting on the Quality and Safety Issues of Drugs and Medical Devices.” The bureau is seeking public feedback from October 10 to November 9, 2024. This initiative encourages entities…
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Sunvozertinib’s Companion Diagnostic Gets NMPA Nod, Fortifying Targeted Therapy Arsenal for NSCLC in China
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Dizal Pharmaceutical Co., Ltd (SHA: 688192) and Burning Rock Ltd (NASDAQ: BNR, FRA: 6BU0) have announced a significant regulatory milestone in China’s precision medicine space. Their jointly developed companion diagnostic (CDx) for epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins), designed to pair with the targeted therapy sunvozertinib,…
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Sino Medical Sciences Secures NMPA Nod for Balloon Guided Catheter to Aid Vascular Procedures
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China-based Sino Medical Sciences Technology Inc. (SHA: 688108) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its balloon guided catheter. The device is designed to assist in the insertion of intravascular catheters and guide them into the target vessel within the peripheral…
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