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Ascentage Pharma’s Lisaftoclax and AceLink Therapeutics’ AL01211 Receive FDA Designations
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The Center for Drug Evaluation (CDE) website has indicated that China-based Ascentage Pharma’s (HKG: 6855) lisaftoclax (APG-2575) and AceLink Therapeutics(Suzhou)’s AL01211 are on track to receive priority review and breakthrough therapy designation (BTD) statuses respectively from the US Food and Drug Administration (FDA). Lisaftoclax, an oral BCL-2 inhibitor, is indicated…
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AskBio’s AB-1003 Receives Rare Pediatric Disease and Orphan Drug Designations from FDA
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Asklepios BioPharmaceutical, Inc. (AskBio), a wholly owned subsidiary of Bayer AG (ETR: BAYN), has announced that it has received both rare pediatric disease designation (RPDD) and orphan-drug designation (ODD) from the US Food and Drug Administration (FDA) for its investigational gene therapy, AB-1003 (LION-101). The therapy targets limb-girdle muscular dystrophy…
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Teva Pharmaceutical Expands Partnerships in China’s One Health Sector with New Agreements
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Israel based Teva Pharmaceutical Industries Ltd (NYSE: TEVA) has announced new partnerships with Chinese firms Zhejiang International Group Co., Ltd. and Jianmin International Co., Ltd. These collaborations aim to enhance Teva’s commercial layout in the “One Health” sector, increasing the availability of quality products for Chinese consumers. Strategic Agreements at…
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Bayer’s Leap Forward: Implementing Salesforce on Alibaba Cloud for Customer Engagement
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Bayer (ETR: BAYN) has announced that its China Prescription Medicines business has fully adopted the “Salesforce on Alibaba Cloud” solution, creating an all-new customer interaction platform, OPERA 2.0, for thousands of internal Bayer users. Bayer is one of the first multinational pharmaceutical companies in China to implement a new customer…
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CDE Releases Technical Guidelines for Pilot Registration and Phased Manufacturing of ADCs
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The Center for Drug Evaluation (CDE) has issued the “Technical Requirements for Pilot Registration and Application of Phased Manufacturing of Antibody Drug Conjugates (ADC).” This document complements the “Pilot Work Plan for Phased Manufacturing of Biological Products” released last month and aims to guide the pilot work of phased manufacturing…
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Shanghai Pharmaceuticals’ MediTrust Health Partners with Eisai for Comprehensive Patient Services
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Shanghai Pharmaceuticals Holding Co., Ltd’s (HKG: 2607, SHA: 601607) subsidiary, MediTrust Health, which specializes in insurance, financing, and direct-to-patient pharmacy services, has entered into a strategic partnership with Japanese pharmaceutical company Eisai (TYO: 4523). This collaboration grants Eisai access to MediTrust Health’s “One-Code Direct Payment-Diversified Payment Platform,” aiming to establish…
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Boehringer Ingelheim Partners with Wuhan Union Hospital to Enhance Clinical Research and Development
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Boehringer Ingelheim, a leading German pharmaceutical company, has entered into a strategic partnership with Wuhan Union Hospital, marking a significant step in the realm of clinical research. This collaboration will extend beyond clinical studies to include academic exchanges, patient education, and talent development, among other areas, in alignment with Boehringer…
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NHSA and MCA Boost Medical Assistance with Enhanced Information Sharing Measures
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The National Healthcare Security Administration (NHSA) and the Ministry of Civil Affairs (MCA) have jointly issued a notification with the goal of enhancing the information sharing process for medical assistance recipients. This initiative is designed to address the issue of delayed inter-departmental information sharing, which impacts the timely disbursement and…
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