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EMA’s CHMP Endorses Bristol Myers Squibb’s CAR-T Therapy Abecma for Multiple Myeloma
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The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has endorsed Bristol Myers Squibb’s (BMS; NYSE: BMY) CAR-T cell therapy, Abecma (idecabtagene vicleucel), for the treatment of relapsed and refractory multiple myeloma (r/r MM) in adults who have undergone at least two prior therapies.…
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Dupixent by Sanofi and Regeneron Approved by FDA for Eosinophilic Esophagitis in Younger Pediatric Patients
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The US Food and Drug Administration (FDA) has concluded a priority review and granted approval to Sanofi (NASDAQ: SNY) and Regeneron (NASDAQ: REGN) for their interleukin blocker Dupixent (dupilumab) as a treatment for eosinophilic esophagitis (EoE) in patients aged 1 to 11 years. This indication expansion makes Dupixent the sole…
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Shandong Boan Biotechnology Strikes Licensing Deal with Joincare for Long-Acting mAb BA2101
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Shandong Boan Biotechnology Co., Ltd (HKG: 6955), based in China, has announced a licensing agreement with fellow Chinese firm Joincare Pharmaceutical Group Industry Co., Ltd (SHA: 600380) for its in-house developed long-acting monoclonal antibody (mAb) BA2101. According to the agreement, Joincare will obtain exclusive rights to develop, regulate, and commercialize…
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Apeloa Pharmaceutical Halts Phase III Trial of Salfaprodil for Acute Ischemic Stroke
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Apeloa Pharmaceutical Co., Ltd (SHE: 000739), a China-based pharmaceutical company, has announced the termination of a Phase III clinical study for its salfaprodil injection, which is being developed as a treatment for acute ischemic stroke. Salfaprodil is a novel NMDA receptor antagonist. According to the public data, Apeloa first filed…
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Laekna Therapeutics Reports Phase II Data for Afuresertib in Platinum-Resistant Ovarian Cancer
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Laekna Therapeutics Shanghai Co., Ltd, a China-based pharmaceutical company, has announced topline data from the global multi-center Phase II PROFECTA-II study for its afuresertib combined with paclitaxel in the treatment of platinum-resistant ovarian cancer (PROC). The Sino-US study aimed to assess the efficacy and safety of the combination therapy in…
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Zhaoke Ophthalmology Strikes Distribution Deal with South Korea’s Kwangdong Pharmaceutical for Brimochol PF
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Lee’s Pharmaceutical Holdings Ltd (HKG: 0950), a China-based pharmaceutical company, through its subsidiary Zhaoke Ophthalmology Ltd (HKG: 6622), has announced a distribution and supply agreement with South Korea’s Kwangdong Pharmaceutical Co., Ltd. The agreement pertains to Brimochol PF, a preservative-free fixed dose of carbachol and bromonidine tartrate, which serves as…
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Yantai Dongcheng’s Radiopharmaceutical 68GaLNC1007 Gets FDA Nod for Diagnostic Use in Solid Tumors
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Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675), a Chinese pharmaceutical company, has announced that it has received approval from the US Food and Drug Administration (FDA) for its radiopharmaceutical 68GaLNC1007. This diagnostic agent targets fibroblast activating protein (FAP) and integrin αvβ3 and is under development to support the treatment…
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Joincare Pharmaceutical Partners with QYuns Therapeutics for Exclusive Rights to QX008N in China and Hong Kong
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Joincare Pharmaceutical Group Industry Co., Ltd (SHA: 600380), a Chinese pharmaceutical company, has announced a strategic cooperation and licensing agreement with Jiangsu QYuns Therapeutics Co., Ltd concerning QX008N, a monoclonal antibody (mAb) that targets thymic stromal lymphopoietin (TSLP). According to the agreement, Joincare will secure exclusive rights to research and…
