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FDA Assures No Disruption to US Drug Supply Chain After Pfizer Warehouse Tornado
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The US Food and Drug Administration (FDA) has issued a statement this week, ruling out any impacts on the local drug supply chain following a tornado that damaged one of Pfizer’s (NYSE: PFE) local sites, primarily the warehouse portion. The facility in question accounts for 8% of the country’s sterile…
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Biotherus Inc. and BioNTech SE Enter Global License Agreement for Cancer Therapies
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China-based biotech company Biotheus Inc. has announced a strategic research collaboration, option, and worldwide license agreement with Germany’s BioNTech SE (NASDAQ: BNTX). The deal grants BioNTech exclusive worldwide options to a preclinical-stage bispecific antibody and a clinical-stage monoclonal antibody for cancer therapy. Additionally, Biotheus will provide BioNTech with exclusive licenses…
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Antengene Corp. Receives FDA Fast-Track Designation for Xpovio in Myelofibrosis Treatment
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China-based biopharma Antengene Corp., Ltd (HKG: 6996) has announced receiving fast-track designation from the US Food and Drug Administration (FDA) for its drug Xpovio (selinexor) in the treatment of myelofibrosis (MF), an indication that covers primary myelofibrosis, myelofibrosis after primary thrombocytosis, and myelofibrosis after polycythemia vera. Background on Xpovio and…
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Riparian Pharmaceuticals Secures Exclusive License Agreement with Pfizer for Cardiovascular Program
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US-based Riparian Pharmaceuticals, Inc., a biotechnology company focused on cardiovascular diseases and co-incubated by Viva Biotech (HKG: 1873), has announced an exclusive license agreement and research agreement with US pharmaceutical giant Pfizer (NYSE: PFE). Under the terms of the agreement, Pfizer will receive exclusive rights to a Riparian preclinical program…
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Acotec Scientific and Boston Scientific Announce Comprehensive Collaboration Agreement
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China-based Acotec Scientific Holdings Ltd (HKG: 6669) has announced a cooperation framework and service framework agreement with US firm Boston Scientific Group plc (BSG, NYSE: BSX), outlining a series of collaborations on global commercialization, product manufacturing service, product research and development (R&D), and other areas over the next three years.…
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Hansoh Pharmaceutical’s Ibrexafungerp NDA Accepted for Review by China’s NMPA for VVC Treatment
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China-based Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) has announced that the National Medical Products Administration (NMPA) has accepted a New Drug Application (NDA) filing for its ibrexafungerp, intended for the treatment of vulvovaginal candidiasis (VVC) in adult and post-menarche females. Phase III Study Results and NDA FilingThe filing is…
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GenScript Biotech’s CAR-T Therapy Carvykti Reports USD 117 Million in Sales
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China-based Contract Research Organization (CRO) GenScript Biotech Corporation (HKG: 1548) has announced that its subsidiary, Legend Biotech Corporation (NASDAQ: LEGN), has reported sales of USD 117 million for its BCMA-directed chimeric antigen receptor T cell (CAR-T) therapy, Carvykti (ciltacabtagene autoleucel), as of June 30, 2023. The sales data, provided by…
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SCG Cell Therapy Launches Global Manufacturing and R&D Center in Singapore with Automated System
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Singapore-based SCG Cell Therapy Pte. Ltd has announced the initiation of its global manufacturing and R&D center in Singapore, marking the launch of a first-in-class, closed-off automated cell therapy production system. The new facility, supported by the Singapore Economic Development Board, aims to fully utilize and expand SCG’s capabilities in…
