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BMS’ Augtyro Receives EMA Review for Advanced Lung Cancer and Solid Tumors Treatments
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The European Medicines Agency (EMA) has accepted for review a filing submitted by Bristol Myers Squibb (BMS; NYSE: BMY) for its orphan drug, Augtyro (repotrectinib), which targets ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) and NTRK-positive locally advanced or metastatic solid tumors. The next-generation tyrosine kinase inhibitor…
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Allorion Therapeutics Strikes Deal with AstraZeneca for EGFR L858R Inhibitor Development and Commercialization
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Allorion Therapeutics, a China-based biopharmaceutical company, has announced an exclusive option and global licensing agreement with AstraZeneca (AZ, NASDAQ: AZN) to develop and commercialize a novel allosteric inhibitor targeting the L858R mutation of the epidermal growth factor receptor (EGFR). The drug is intended for the treatment of advanced EGFR mutant…
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Orient Gene Biotech to Acquire Hangzhou Laihe Biotech, Expanding POCT and AI in Healthcare
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Zhejiang Orient Gene Biotech Co., Ltd, a leading biotech company in China, is poised to acquire Hangzhou Laihe Biotech Co., Ltd, a move that will grant its subsidiary full control over the latter. This strategic acquisition is set to create synergies, given Laihe Bio’s specialization in drug testing and infectious…
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Shanghai Teogen Life Technology and China National Medical Device Form Strategic Partnership
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Shanghai Teogen Life Technology Co., Ltd, a Chinese-based company, has announced a strategic partnership with its compatriot, China National Medical Device Co., Ltd. The collaboration aims to integrate the respective resource advantages of both companies, optimizing their cooperation layout and enhancing practical collaboration in product promotion and marketing. The financial…
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Shanghai Pharmaceuticals and Sanofi Broaden Collaboration to Include Nationwide Disease Management
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Shanghai Pharmaceuticals (SPH; HKG: 2607; SHA: 601607) , a leading pharmaceutical company based in China, has entered into a comprehensive partnership with the French pharmaceutical giant Sanofi (NASDAQ: SNY). The collaboration aims to address major disease areas on a nationwide scale, establishing an end-to-end value chain system that spans from…
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Servier Faces $475 Million Penalty Over Banned Antidiabetic Drug Mediator in France
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French pharmaceutical company Servier has been ordered by a French court to pay €430.6 million ($475 million) in a partial reversal of a 2021 decision concerning its now-banned antidiabetic drug, Mediator (benfluorex). The new ruling has found Servier guilty of fraud, improper acquisition of regulatory authorizations, aggravated deception, and involuntary…
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J&J Shareholders Cleared to Sue Over Hidden Asbestos Risks in Talc Products
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A US federal court has granted permission for certain Johnson & Johnson (J&J; NYSE: JNJ) shareholders to initiate a class action lawsuit against the company for allegedly concealing the presence of oncogenic asbestos in its talc products. The decision, which impacts stock price events between 2017 and 2018, covers stockholders…
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China’s CDE Releases Guidelines for CGT Clinical Trials Communication
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The Center for Drug Evaluation (CDE) in China has released the “Technical Guiding Principles for Cell and Gene Therapy (CGT) Product Clinical Communication and Exchange,” addressing the unique considerations of personalized and specific CGT products. Applicants are advised to focus on critical factors such as product characteristics, clinical positioning, target…
