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Hasten Biopharmaceutical Secures Licensing Deal for LIB’s Lerodalcibep in Greater China
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China-based Hasten Biopharmaceutical Co., Ltd has entered into a licensing agreement with US firm LIB Therapeutics Inc., securing the development and commercial rights to LIB’s lerodalcibep for the Greater China territory, which includes mainland China, Hong Kong, Macau, and Taiwan. The agreement involves an upfront payment of USD 20 million…
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FDA Extends Pfizer’s Comirnaty Vaccine Indication for Omicron XBB.1.5 Variant
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The US Food and Drug Administration (FDA) has granted Pfizer (NYSE: PFE) an indication extension for its SARS-CoV-2 Omicron XBB.1.5 single-dose monovalent vaccine, Comirnaty. The vaccine is now approved for individuals aged 12 years and older, in addition to receiving an emergency use authorization (EUA) for children between 6 months…
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Amgen’s Lumakras Combo Shows Promising Results in KRAS-mutated NSCLC Early-Stage Trial
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Amgen (NASDAQ: AMGN) has announced positive early-stage data for its KRASG12C inhibitor Lumakras (sotorasib) when combined with carboplatin and pemetrexed in the treatment of KRAS G12C-mutated advanced non-small cell lung cancer (NSCLC) in adults. The confirmed objective response rate (ORR) and disease control rate (DCR) in treatment-naive patients were 65%…
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Gilead’s Trodelvy Combo with MSD’s Keytruda Shows Promise in NSCLC Phase II Trial
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Gilead (NASDAQ: GILD) has announced interim data from a Phase II trial assessing the antibody-drug conjugate (ADC) Trodelvy (sacituzumab govitecan) in combination with Merck, Sharp & Dohme’s (MSD; NYSE: MRK) anti-PD-1 Keytruda (pembrolizumab) for first-line advanced or metastatic non-small cell lung cancer (NSCLC) without actionable genomic alterations. The interim results…
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Wecare Medical Secures Pre-Series A Funding to Advance Brain Health Technology
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Hangzhou-based Wecare Medical, a developer of brain disease diagnosis, monitoring, and treatment products, has reportedly raised tens of millions of renminbi in a Pre-Series A financing round. The round was led by Noyu Capital, with the proceeds earmarked for accelerating the development of temporal interference-based non-invasive deep brain electrical stimulation…
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Sandoz Inks Deal with Samsung Bioepis for Ustekinumab Biosimilar SB17
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The Sandoz (SWX: SDZ) unit of Switzerland-based Novartis (NYSE: NVS) has announced the in-licensing of ustekinumab biosimilar SB17 from South Korea’s Samsung Bioepis. The agreement covers the markets of Canada, the European Economic Area (EEA), Switzerland, UK, and the US. The biosimilar references Johnson & Johnson (J&J; NYSE: JNJ) subsidiary…
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China Updates Narcotics and Psychotropic Substances Catalog, Adds Three Substances
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The National Medical Products Administration (NMPA), Ministry of Public Security, and National Health Commission have jointly released a notification regarding the adjustment of the narcotics and psychotropic substances catalog in China. The updated catalog, which will come into effect on October 1, 2023, sees the addition of three new varieties,…
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Sinovac Biotech Advances SA55 COVID-19 Neutralizing Antibody into Phase II Trials
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China-based vaccines firm Sinovac Biotech Ltd (NASDAQ: SVA) has announced the completion of a Phase I trial and the immediate initiation of a Phase II study for its broad-spectrum COVID-19 neutralizing antibody, SA55. The molecule, which was first approved to enter clinical trials in China on May 24 this year,…
