Pharmaceuticals
GenAssist Ltd Announces FDA Clearance of Investigational New Drug Application for GEN6050X, a Globally First-in-Class Base Editing Drug for Duchenne Muscular Dystrophy
SUZHOU, China, March 6, 2025 /PRNewswire/ -- On March 06, 2025, GenAssist Ltd (GenAssist), a pioneering gene-editing biotechnology company specializing in genome medicines, is thrilled to announce that it has receivedclearance from the U.S Food and Drug Administration(FDA) for its Investigational...
2025-03-06 17:00
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Everest Medicines Announces First Patient Dosed with EVM16, Its First Internally Developed Personalized mRNA Cancer Vaccine
* The first patient has been dosed with EVM16 at Peking University Cancer Hospital, marking a major milestone as Everest's proprietary AI-based tumor neoantigen prediction algorithm and clinically validated mRNA platform progress into human trials. * In preclinical studies, EVM16 demonstrated...
2025-03-06 16:30
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Akeso Announces Completion of Patient Enrollment in The Phase III Clinical Trial of Cadonilimab for Adjuvant Treatment of High-Risk Recurrent Hepatocellular Carcinoma
HONG KONG, March 5, 2025 /PRNewswire/ -- Akeso, Inc. (9926. HK) ("Akeso" or the "Company") is pleased to announce the completion of patient enrollment for its Phase III registrational clinical trial (COMPASSION-22/AK104-306) evaluating cadonilimab, the world's first PD-1/CTLA-4 bispecific antibod...
2025-03-06 08:30
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CStone Submits Clinical Trial Application in Australia for CS5001 (ROR1 ADC) in Combination with First-Line Standard-of-Care for DLBCL
* Phase Ib trial to evaluate CS5001 in combination with R-CHOP as a first-line treatment for diffuse large B-cell lymphoma (DLBCL), aiming to reshape the standard-of-care landscape. * CS5001 is also being investigated globally in a multi-center Phase Ib clinical trial for multiple solid tumor...
2025-03-06 08:10
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Laminar Pharma Announces first open-label Progression-Free Survival data for LAM561 in combination with standard of Care in First-Line Therapy for Newly Diagnosed Glioblastoma MGMT-methylated patients
PALMA DE MALLORCA, Spain, March 5, 2025 /PRNewswire/ -- Laminar Pharma, a leader in the development of innovative cancer therapy based on membrane lipid therapy, announced today optimistic results from its ongoing clinical trial evaluating LAM561 for the treatment of newly diagnosed glioblastoma ...
2025-03-05 22:45
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SECuRE trial update: 92% of pre-chemo participants experience greater than 35% drop in PSA levels across all cohorts. Cohort Expansion Phase commences.
HIGHLIGHTS * Safety Review Committee (SRC) meeting confirms end of the Dose Escalation Phase and commencement of the Cohort Expansion Phase (Phase II stage) of the SECuRE study. * Based on the efficacy and safety assessment of all cohorts and the focus on earlier stages of treatment, the SRC...
2025-03-05 21:44
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SanyouBio Launches 73 Whole-Series Bispecific Reference Antibody Products, Facilitating New Breakthroughs in Bispecific Drug Development
SHANGHAI, March 5, 2025 /PRNewswire/ -- SanyouBio announced today the official launch of 73 whole-series bispecific antibody reference products, covering globally approved and representative clinical-stage bispecific antibody drugs. The launch of this product series will provide robust support fo...
2025-03-05 20:00
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CordenPharma Expands Peptide Platform with more than 500 Million Euro Greenfield Facility Construction in the Basel Region of Switzerland
* CordenPharma is making a record investment of >€1 billion over the next 3 years in building and / or expanding small, medium, and large peptide manufacturing facilities acrossEurope and the US. * In Switzerland, CordenPharma will invest >€500m to construct a greenfield site for small to lar...
2025-03-05 13:30
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XPOVIO® (selinexor) Approved for Commercialization in Indonesia, Further Expanding Antengene's Commercial Presence in APAC
- XPOVIO® is the first and only approved XPO1 inhibitor in Indonesia. - From the second half of 2024 to now, XPOVIO® was successively approved in Thailand, Malaysia and Indonesia, significantly expanding Antengene's commercial presence in APAC. To date, XPOVIO® has been approved for multiple ind...
2025-03-05 13:00
2166
XPOVIO® (selinexor) Approved for Commercialization in Indonesia, Further Expanding Antengene's Commercial Presence in APAC
- XPOVIO® is the first and only approved XPO1 inhibitor in Indonesia. - From the second half of 2024 to now, XPOVIO® was successively approved in Thailand, Malaysia and Indonesia, significantly expanding Antengene's commercial presence in APAC. To date, XPOVIO® has been approved for multiple ind...
2025-03-05 13:00
2376
GHIT-backed Innovation Achieves Landmark: New Treatment Option for Schistosomiasis Reaches Preschool-Aged Children
TOKYO, March 5, 2025 /PRNewswire/ -- The Global Health Innovative Technology (GHIT) Fund is today announcing a significant milestone: the first administration of arpraziquantel to preschool-aged children inUganda, in an implementation science setting. This new pediatric treatment for schistosomi...
2025-03-05 09:00
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Celltrion receives U.S. FDA approval for STOBOCLO® (denosumab-bmwo) and OSENVELT® (denosumab-bmwo) biosimilars referencing PROLIA® and XGEVA®
* STOBOCLO® (denosumab-bmwo) and OSENVELT® (denosumab-bmwo) are approved by FDA for all indications of reference products PROLIA® (denosumab) and XGEVA® (denosumab) respectively[1], [2] * The FDA approval is based on robust clinical evidence, which show no clinically meaningful differences fr...
2025-03-04 12:28
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Raziel and Fosun Pharma (by JuveStar an affiliate company of Fosun Pharma) Initiate Phase 3 Registration Trial in China for Submental Fat Reduction ("double chin")
REROVOT, Israel, March 3, 2025 /PRNewswire/ -- Raziel Therapeutics, a pharmaceutical company developing next-generation novel prescription products for the medical aesthetics market, announces phase 3 study initiation inChina for the treatment of fat reduction in the submental area. Submental fat...
2025-03-04 09:00
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Raziel and Fosun Pharma (by JuveStar an affiliate company of Fosun Pharma) Initiate Phase 3 Registration Trial in China for Submental Fat Reduction ("double chin")
REROVOT, Israel, March 4, 2025 /PRNewswire/ -- Raziel Therapeutics, a pharmaceutical company developing next-generation novel prescription products for the medical aesthetics market, announces phase 3 study initiation inChina for the treatment of fat reduction in the submental area. Submental fat...
2025-03-04 09:00
1826
CStone Announces First Patient Dosed in Global Multicenter Phase I Clinical Trial of CS2009, a PD-1/VEGF/CTLA-4 Trispecific Antibody
SUZHOU, China, March 3, 2025 /PRNewswire/ --CStone Pharmaceuticals ("CStone", HKEX: 2616), an innovation-driven biopharmaceutical company focused on the research and development of anti-cancer therapies, today announced thatthe first patient has been successfully dosed in the global multicenter P...
2025-03-04 08:10
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Investor Webinar: Telix Therapeutics Urology Showcase and Expert Forum
MELBOURNE, Australia and INDIANAPOLIS, Ind., March 4, 2025 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) invites investors to join a webinar showcasing the Company's late-stage and next-generation radiotherapeutic candidates in urologic oncology. In ...
2025-03-04 05:58
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Callio Therapeutics Launches with US$187 Million Series A to Advance Multi-Payload Antibody-Drug Conjugate Platform Through Clinical Proof-of-Concept
* Frazier Life Sciences launches Callio Therapeutics based on multi-payload antibody-drug conjugate technology and programs exclusively in-licensed from Singapore-based Hummingbird Bioscience * Financing led by Frazier Life Sciences with significant participation from Jeito Capital alongside o...
2025-03-03 22:00
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Acurx Announces Publication of Nonclinical In Vivo Data Differentiating Ibezapolstat's Gut Microbiome Effects from Other Anti-CDI Antibiotics
* First ever head-to-head comparison of gut microbiome changes associated with ibezapolstat (IBZ) to other anti-CDI antibiotics in a germ-free mouse model * Changes in alpha and beta microbiome diversities following IBZ treatment were less pronounced compared to those observed in vancomycin (VA...
2025-03-03 21:00
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METiS Pharmaceuticals Appoints Mark Herbert as Chief Business Officer
HANGZHOU, China, March 3, 2025 /PRNewswire/ -- METiS Pharmaceuticals, a clinical-stage, AI-driven biotechnology company specializing in innovative drug delivery technologies, today announced the appointment ofMark Herbert as Chief Business Officer (CBO), effectiveJanuary 22, 2025. In this role, M...
2025-03-03 16:20
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Sole Pharma - Launches in the Philippines to Meet Rising Demand for High-Quality Supplements
MANILA, Philippines, March 3, 2025 /PRNewswire/ -- In response to the growing demand for high-quality health supplements in the Philippines, Sole Pharma, as one of the leading Europeanpharmaceutical manufacturer, announces its expansion into the Southeast Asian market. Products are available onli...
2025-03-03 08:55
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