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BioNTech and Duality’s DB-1305 Earns Fast-Track Status for Platinum-Resistant Cancers
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German biotechnology company BioNTech SE (NASDAQ: BNTC) and its partner Duality Biologics (Suzhou) Co., Ltd have received fast-track designation from the U.S. Food and Drug Administration for their jointly developed drug candidate DB-1305/BNT325. This designation is in recognition of the drug’s potential to treat platinum-resistant epithelial ovarian cancer, fallopian tube…
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NMPA Reports Record 61 Innovative Medical Device Approvals in 2023
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The National Medical Products Administration (NMPA) has released its 2023 medical device filings work report, detailing the review and approval processes over the past year. In 2023, the NMPA received 13,260 applications for initial registration, renewal registration, and change registration of medical devices, representing a 25.4% increase from 2022. The…
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Novartis to Acquire MorphoSys for €2.7 Billion in Strategic Oncology Expansion
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Switzerland-based Novartis (NYSE: NVS) has announced a voluntary public takeover offer to acquire Germany-based biopharmaceutical firm MorphoSys (FSE: MOR; NASDAQ: MOR) for €2.7 billion. The transaction is anticipated to finalize in the first half of 2024, pending the fulfillment of customary conditions. By acquiring MorphoSys, Novartis aims to incorporate two…
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Bayer Partners with TetraScience to Enhance Data Management in Product Development
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Germany-based Bayer (ETR: BAYN) has announced a partnership with data management firm TetraScience to collect and process cloud-based scientific data, facilitating enhanced insights for its researchers in product development across various sectors, including cell and gene therapy, biopharma, and crop sciences. This collaboration is a key component of Bayer’s digital…
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Zhejiang Anglikang Enters R&D Cooperation Agreement with Affinity Biopharmaceutical
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China-based Zhejiang Anglikang Pharmaceutical Co., Ltd. (SHE: 002940) has entered into a research and development (R&D) collaboration and licensing agreement with fellow domestic entity Affinity Biopharmaceutical Co., Ltd. Under the terms of the agreement, Affinity grants Anglikang exclusive rights for R&D, manufacturing, and commercialization of QHL-1618, a fully water-soluble small-molecule…
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Novo Holdings to Acquire Catalent for $16.5 Billion in Strategic Move to Enhance Biopharmaceutical Capacity
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Novo Holdings, the principal shareholder of Denmark’s Novo Nordisk (CPH: NOVO-B), has announced a definitive agreement to acquire contract development and manufacturing organization (CDMO) Catalent (NYSE: CTLT) for $16.5 billion. The transaction is expected to be finalized by the end of the year, pending customary regulatory conditions. This acquisition comes…
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MSD’s Keytruda Secures 13th Indication Approval in China for Biliary Carcinoma Treatment
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Merck, Sharp & Dohme (MSD; NYSE: MRK), a leading US pharmaceutical company, has announced that its drug Keytruda (pembrolizumab) has received approval from the National Medical Products Administration (NMPA) in China for a new indication. The drug is now approved as a first-line treatment for locally advanced or metastatic biliary…
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Peijia Medical’s Taurus Atlas Pro Balloon Dilation Catheter Approved by NMPA for Pulmonary Valve Procedures
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Peijia Medical Ltd (HKG: 9996) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its second-generation balloon dilation catheter, Taurus Atlas Pro. This non-compliant balloon is designed for percutaneous transluminal valvuloplasty of the pulmonary valve. The Taurus Atlas Pro balloon dilation catheter is…
