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CARsgen Therapeutics’ BCMA-targeted CAR-T Cell Therapy Approved by China’s NMPA
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CARsgen Therapeutics Holdings Ltd (HKG: 2171), a specialist in chimeric antigen receptor (CAR)-T cell therapies based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its product CT053 (zevorcabtagene autoleucel; zevor-cel). This B-cell maturation antigen (BCMA)-targeted CAR-T cell therapy is now…
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Takeda Partners with Biological E to Boost Production of Dengue Vaccine QDenga
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Takeda (TYO: 4502), a leading Japanese pharmaceutical company, has entered into an agreement with India-based Biological E (BE) with the aim of increasing production capacity for its dengue tetravalent vaccine, QDenga. This strategic partnership is part of Takeda’s broader plan to manufacture 100 million doses of the vaccine annually. QDenga,…
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FDA Withdraws Approval for Multiple Myeloma Drug Pepaxto Over Safety and Efficacy Concerns
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The US Food and Drug Administration (FDA) has announced its final decision to withdraw approval for Pepaxto (melphalan flufenamide), a drug initially approved for use in combination with dexamethasone to treat certain patients with multiple myeloma (MM). The decision stems from two key factors: (1) a confirmatory study, conducted as…
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Chia Tai Tianqing’s Anlotinib-Benmelstobart Combo Therapy Receives CDE Review for Endometrial Cancer
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Chia Tai Tianqing, a renowned biopharmaceutical company based in China, has announced that the Center for Drug Evaluation (CDE) has accepted for review a new indication filing for its anlotinib (trade name: FOCUS V) in combination with the anti-programmed death-ligand 1 (PD-L1) monoclonal antibody (mAb) benmelstobart (TQB2450). The proposed indication…
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CanSino Biologics’ 13-Valent Pneumococcal Vaccine CRM197 Accepted for NMPA Review
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CanSino Biologics Inc., (HKG: 6185), a leading Chinese biopharmaceutical company, has announced that the National Medical Products Administration (NMPA) has accepted for review the New Drug Application (NDA) for its CRM197, a 13-valent pneumococcal polysaccharide conjugate vaccine (TT vector). This development marks a significant step forward in the advancement of…
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Jenscare Scientific Achieves Milestone with First LuX-Valve Plus Implantation in Brazil
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Jenscare Scientific Co., Ltd (HKG: 9877), a leading structural heart disease device manufacturer headquartered in Ningbo, China, has announced the successful completion of the first clinical implantation surgery using its transjugular tricuspid valve replacement product, LuX-Valve Plus, in Brazil. This milestone marks a significant advancement for the company in the…
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Viatris Secures Late-Stage Programs from Idorsia with Potential for Future Asset Additions
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US pharmaceutical company Viatris (NASDAQ: VTRS) has entered into a licensing agreement with Swiss drugmaker Idorsia (SWX: IDIA), in-licensing two late-stage programs with the option to add two more innovative assets in the future. Viatris will pay Idorsia an upfront fee of USD 350 million, along with potential milestone payments…
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MicroPort CardioFlow Forecasts 31%-36% YOY Sales Growth for 2023 Driven by TAVI Product Expansion
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MicroPort CardioFlow Medtech Co., Ltd (HKG: 2160), a spin-off from China-based MicroPort Scientific Corp (HKG: 0853), has announced a forecast for its 2023 financial performance along with key business updates. The company anticipates generating sales within the range of RMB 330 million to RMB 340 million for the year, reflecting…
