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Boan Biotech Secures FDA Orphan Drug Designations for Pancreatic Cancer Treatments
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China-based Boan Biotech (HKG: 6955) has announced that its novel antibody BA1105 and antibody-drug conjugate (ADC) BA1301 have received orphan drug designations (ODDs) from the U.S. Food and Drug Administration (FDA). Both therapies target Claudin18.2 (CLDN18.2) for the treatment of pancreatic cancer. BA1105 is being developed for Claudin18.2 positive advanced…
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Eli Lilly Teams Up with Fauna Bio to Uncover New Anti-Obesity Drug Targets
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Eli Lilly (NYSE: LLY) has entered a collaboration agreement with fellow U.S. firm Fauna Bio to explore novel anti-obesity drug targets, marking a significant step in the competitive weight-loss therapies market. The financial terms of the deal include an undisclosed upfront payment, potential sales royalties, and up to $494 million…
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Gilead’s Kite Receives FDA Nod to Add Overall Survival Data to Yescarta for Large B-Cell Lymphoma
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Gilead Sciences Inc. (NASDAQ: GILD) subsidiary Kite has received approval from the U.S. Food and Drug Administration (FDA) to update the label of Yescarta (axicabtagene ciloleucel) to include overall survival (OS) data for its use as a second-line treatment for relapsed or refractory large B-cell lymphoma (r/r LBCL). This new…
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FDA Prioritizes Roche’s Xolair for Food Allergy Indication Extension Ahead of Q1 Decision
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The U.S. Food and Drug Administration (FDA) has prioritized Roche’s (SWX: ROG) indication extension filing for Xolair (omalizumab), marking it as the first treatment in the U.S. aimed at reducing allergic reactions associated with accidental food exposure in patients with food allergies. The FDA granted biologic breakthrough therapy designation (BTD)…
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Lepu Biotechnology Completes Enrollment for Phase IIb Trial of MRG003 in Nasopharyngeal Carcinoma
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Lepu Biotechnology Co., Ltd (HKG: 2157), based in China, has announced the completion of subject enrollment in its Phase IIb clinical study for MRG003, its flagship product targeting recurrent/metastatic nasopharyngeal carcinoma (R/M NPC). The randomized, open-label, multi-center pivotal study aims to evaluate the efficacy and safety of this epidermal growth…
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Sino Medical Secures Approvals for Key Coronary Devices in Taiwan, India, and Uzbekistan
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Sino Medical Sciences Technology Inc. (SHA: 688108), a China-based medical device company, has announced that it has received market approvals in Taiwan, India, and Uzbekistan for its SC HONKYTONK coronary artery balloon dilation catheter, NC Rockstar non-compliant coronary artery balloon dilation catheter, and HT Supreme drug-eluting stent system. The NC…
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Shanghai Henlius Secures Indonesian Approval for HanSiZhuang in Small-Cell Lung Cancer
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Shanghai Henlius Biotech Inc. (HKG: 2696) has received market approval from the Indonesian Food and Drug Authority (Badan Pengawas Obat dan Makanan) for its anti-PD-1 monoclonal antibody, HanSiZhuang (serplulimab). This approval allows the drug to be used in the treatment of extensive-stage small-cell lung cancer (ES-SCLC). Henlius is collaborating with…
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IVD Medical Ends Strategic Partnership with Japan’s Sysmex in Coagulation Products
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IVD Medical Holding Ltd (HKG: 1931), a China-based in vitro diagnostic (IVD) specialist, has announced the termination of its strategic partnership agreement with Japan’s Sysmex Corporation concerning its coagulation product business. The partnership, initially established in November 2023, involved Sysmex investing in IVD Medical’s subsidiary, thereby becoming a shareholder and…
