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Merck’s Keytruda Gains Two Additional EU Indications for Gynecologic Cancer Treatment
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Merck, Sharp & Dohme Inc., known as MSD (NYSE: MRK), has received two additional indication approvals from the European Union for its immunotherapy drug Keytruda (pembrolizumab), increasing the total number of approved uses in the region to 30. The PD-1 inhibitor is now approved for use in combination with carboplatin…
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WuXi AppTec Reports Q3 2024 Revenues of RMB 10.46 Billion Amid Biosecure Act Challenges
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WuXi AppTec Co., Ltd (SHA: 603259), the China-based Contract Development and Manufacturing Organization (CDMO) facing potential restrictions under the Biosecure Act—set to ban drugmakers with U.S. government contracts from utilizing Chinese services post-2032—reported its financial results for the first three quarters of 2024. In the third quarter, revenues reached RMB…
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Monte Rosa Therapeutics Strikes Licensing Deal with Novartis for VAV1 Degraders
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US-based Monte Rosa Therapeutics (NASDAQ: GLUE) has entered into a licensing agreement with Swiss pharmaceutical company Novartis (NYSE: NVS), granting Novartis exclusive global development and commercialization rights to Monte Rosa’s VAV1-targeted molecular glue degraders (MGDs), including the investigational drug MRT-6160. As per the agreement, Novartis will make an upfront payment…
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Jiangsu Hengrui Pharmaceuticals Advances Clinical Trials for Cancer Therapies with NMPA Clearance
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has received clinical clearance from China’s National Medical Products Administration (NMPA) for a suite of cancer treatments, including HRS-4642 (adebrelimab), SHR-1826, SHR-8068, and a bevacizumab biosimilar. The company is set to initiate a multi-center, open Phase Ib/II study to evaluate the safety, tolerability,…
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AstraZeneca’s Fasenra Approved by EU for Eosinophilic Granulomatosis Treatment
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UK pharmaceutical giant AstraZeneca Inc. (NASDAQ: AZN) has received marketing approval from the European Commission for its drug Fasenra (benralizumab) as an additional treatment for adult patients suffering from relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA). The approval follows the successful outcomes of the MANDARA Phase III trial, marking…
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AbbVie Inks $1.4 Billion Deal to Acquire Alzheimer’s Drug Developer Aliada Therapeutics
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US pharmaceutical company AbbVie (NYSE: ABBV) has entered into a definitive agreement to acquire all outstanding equity of Aliada Therapeutics, Inc., a fellow US firm, for $1.4 billion in cash. The acquisition includes ALIA-1758, an anti-pyroglutamate amyloid beta (3pE-Aβ) antibody in development for the treatment of Alzheimer’s disease (AD). Aliada’s…
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CSPC Pharmaceutical’s SYS6020 Receives NMPA Approval for Myasthenia Gravis Clinical Trial
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CSPC Pharmaceutical Group Ltd (HKG: 1093), a leading pharmaceutical company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its SYS6020. This investigational treatment is a BCMA-targeted chimeric antigen receptor (CAR)-T cell therapy intended for myasthenia gravis (MG). Notably,…
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Eli Lilly’s Ebglyss Shows Positive Results in Phase III Study for Atopic Dermatitis Patients Previously Treated with Dupilumab
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Eli Lilly & Co. (NYSE: LLY), a leading U.S. pharmaceutical company, has announced the results of the Phase III Adapt study for its interleukin-13 (IL-13) inhibitor, Ebglyss (lebrikizumab). The study demonstrated that Ebglyss improved skin conditions, including on the hands and face, and reduced itch in patients with moderate-to-severe atopic…
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CANbridge Pharmaceuticals Scales Back US Operations, Focuses on China for R&D and Commercialization
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CANbridge Pharmaceuticals Inc., (HKG: 1228), a China-based pharmaceutical company specializing in rare diseases, has announced recent developments regarding its operations in the United States, where the company is considering scaling down its presence. The management has decided to terminate a licensing agreement with the University of Massachusetts (UMASS) that was…
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Biogen’s Felzartamab Demonstrates Promising Results in Phase II Study for IgA Nephropathy
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Biogen Inc. (NASDAQ: BIIB), a prominent biopharmaceutical company based in the U.S., has announced comprehensive results from the Phase II IGNAZ study for felzartamab in the treatment of IgA nephropathy. The findings were showcased at Kidney Week 2024, the annual meeting of the American Society of Nephrology. The study demonstrated…
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Humanwell Healthcare Receives NMPA Approval for Chemically Synthesized Semaglutide Clinical Trial
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Humanwell Healthcare (Group) Co., Ltd (SHA: 600079), a leading healthcare company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its Category 2.2 chemically synthesized semaglutide injection, intended for the treatment of type 2 diabetes. Semaglutide, a glucagon-like peptide-1…
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RiboX Therapeutics’ Circular RNA Therapy RXRG001 Gets FDA Green Light for Dry Mouth Clinical Trial
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RiboX Therapeutics, a Shanghai-based developer of circular RNA (circRNA) therapies, has announced that it has received approval from the US Food and Drug Administration (FDA) to initiate the Phase I/IIa clinical study SPRINX-1 for its candidate RXRG001. This study will evaluate the efficacy and safety of RXRG001 in patients suffering…
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AstraZeneca’s Zoladex Receives NMPA Approval for Higher Dosage Form in Breast Cancer Treatment
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AstraZeneca Inc., (AZ, NASDAQ: AZN), a UK-based pharmaceutical giant, has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its Zoladex (goserelin sustain-released implant) 10.8mg. This new dosage form is intended for use in premenopausal and perimenopausal women with breast cancer who can be…
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MicuRx Pharmaceuticals’ Antibiotic MRX-5 Completes Successful Phase I Clinical Trial in Australia
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MicuRx Pharmaceuticals Inc. (SHA: 688373), a Sino-US pharmaceutical company, has announced the successful completion of a Phase I clinical study for its in-house developed antibiotic, MRX-5, in Australia. This new benzodiazole antibiotic is designed to treat infections caused by Mycobacterium, with a particular focus on non-tuberculosis Mycobacterium (NTM). The Phase…
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NMPA’s CDE Prioritizes Marketing Filings for Innovative Drugs with Priority Review Status
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The Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) released a notification last week, announcing that marketing filings for innovative drugs and varieties that have been confirmed to receive priority review and conditional approval statuses will be given precedence in processing, effective as of November 1,…
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Wantai Biological’s P85 Ab Detection Kit Receives NMPA Approval for Nasopharyngeal Carcinoma Screening
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Beijing Wantai Biological Pharmacy Enterprise Co., Ltd (SHA: 603392), a Chinese pharmaceutical company, announced last week that it has received marketing approval from the National Medical Products Administration for its EB virus BNLF2b antibody (P85 Ab) detection kit, which utilizes the magnetic particle chemiluminescence method. This product is a collaborative…
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Chinese ADCs from Escugen, Hansoh, and MediLink Therapeutics Eye Breakthrough Designations in China
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The Center for Drug Evaluation of the National Medical Products Administration (NMPA) has indicated on its website that three antibody drug conjugates (ADCs) from Chinese pharmaceutical companies are on track to receive breakthrough therapy designations (BTDs) in China. These include Shanghai Escugen’s ESG401, Jiangsu Hansoh Pharmaceutical Co., Ltd (HKG: 3692)’s…
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GSK Commits USD 800 Million to New State-of-the-Art Manufacturing Facility in Pennsylvania
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GSK plc (NYSE: GSK), a leading UK pharmaceutical company, has announced a significant investment in the United States with the establishment of a multi-purpose facility in Marietta, Pennsylvania. The company will invest USD 800 million to develop a state-of-the-art drug substance manufacturing facility and additional drug product manufacturing capabilities, creating…
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ImmuneOnco Biopharmaceuticals Partners with Yangtze River Pharmaceutical to Boost Pipeline Development
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ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd (HKG: 1541), a biopharmaceutical company based in China, has entered into a strategic partnership with fellow Chinese firm Yangtze River Pharmaceutical (Group) Co., Ltd. This collaboration aims to strengthen and enhance the development of ImmuneOnco’s investigational pipeline programs. The partnership encompasses a wide range of…
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LaNova Medicines Regains Rights to Claudin 18.2 Targeting ADC LM-302 from BMS
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LaNova Medicines Ltd, a Shanghai-based developer of cancer therapies, has announced the reclamation of control over LM-302, an antibody drug conjugate (ADC) targeting Claudin 18.2, from US pharmaceutical giant Bristol-Myers Squibb (BMS; NYSE: BMY). LaNova had previously signed an agreement with Turning Point Therapeutics, Inc. (TPTX.US) in May 2022 to…
