Pharmaceuticals
Kelun-Biotech's TROP2 ADC Sacituzumab Tirumotecan (sac-TMT) Approved for Marketing in Second Indication by NMPA for EGFRm NSCLC
CHENGDU, China, March 10, 2025 /PRNewswire/ -- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the "Company") announced that the Company's trophoblast cell-surface antigen 2 (TROP2)-directed antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT, formerly SKB264/MK-2870) was approved ...
2025-03-10 19:22
2543
Lundbeck's potential treatment for Multiple System Atrophy granted Orphan Drug Designation in Japan
VALBY, Denmark, March 10, 2025 /PRNewswire/ -- The Ministry of Health, Labor, and Welfare (MHLW) inJapan has granted Orphan Drug Designation (ODD) to Lundbeck's investigational drug, amlenetug, a potential new treatment option targeting Multiple System Atrophy (MSA). H. Lundbeck A/S (Lundbeck) a...
2025-03-10 16:57
2342
Doer Biologics Completes Enrollment of the Phase 2 Clinical Study of DR10624 for Treatment of Severe Hypertriglyceridemia
HANGZHOU, China, March 9, 2025 /PRNewswire/ -- Zhejiang Doer Biologics Co., Ltd. ("Doer Bio"), a clinical stage biopharmaceutical company developing innovative biotherapeutics for metabolic diseases and cancers,today announces that DR10624, its first-in-class (FIC), tri-specific agonist targeting...
2025-03-10 10:53
2439
RiboX Therapeutics Announces First Patient Dosed in Phase I/IIa Clinical Trial of RXRG001, the First Circular RNA Therapy for the Treatment of Radiation-Induced Xerostomia and Hyposalivation
PRINCETON, N.J., March 9, 2025 /PRNewswire/ -- RiboX Therapeutics Ltd. (RiboX), a pioneering biopharmaceutical company, focused on discovering and developing fully engineered circular RNA therapeutics, today announced that the first patient was dosed last week in its first-in-human (FIH) Phase I/...
2025-03-10 09:30
2796
U.S. FDA approves Celltrion's OMLYCLO® (omalizumab-igec) as the first and only biosimilar with interchangeability designation referencing XOLAIR®
* OMLYCLO® (omalizumab-igec) is the first and only omalizumab biosimilar approved by theFDA * Regulatory approval for interchangeability was supported by positive phase III data demonstrating comparable efficacy and safety profile with the reference product XOLAIR® (omalizumab)[1] * The ava...
2025-03-10 07:16
3601
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
2296
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
2896
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
2781
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
2964
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
2264
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
3365
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
2465
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
2908
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
2664
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
2802
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
2506
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
2982
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
2212
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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