Pharmaceuticals
Norgine welcomes PBS listing in Australia of IFINWIL® (eflornithine) for patients with high-risk neuroblastoma (HRNB)
This news is for Australian Media only * Eflornithine is now reimbursed by the government under Australia's Pharmaceutical Benefits Scheme (PBS). The Pharmaceutical Benefits Advisory Committee (PBAC) recommended the listing of eflornithine for post-maintenance treatment to prevent relapse in p...
2025-08-01 06:01
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Alphamab Oncology Announces Anti-HER2 Biparatopic ADC JSKN003 Received U.S. FDA IND Approval to Initiate a Phase II Clinical Study for Platinum-Resistant Ovarian Cancer
SUZHOU, China, July 31, 2025 /PRNewswire/ -- Alphamab Oncology (stock code: 9966.HK) announced that anti-HER2 biparatopic antibody-drug conjugate (ADC) JSKN003 has received approval from the U.S. Food and Drug Administration (FDA) to initiate a Phase II clinical study inthe United States (study n...
2025-07-31 18:36
2758
Chipscreen Biosciences' Brain-Penetrant Aurora B Selective Inhibitor CS231295 Tablet Receives FDA IND Approval, Advancing Global Clinical Development
SHENZHEN, China, July 31, 2025 /PRNewswire/ -- Shenzhen Chipscreen Biosciences Co., Ltd. ("Chipscreen Biosciences") announced that its wholly owned subsidiary, Chipscreen Biosciences (USA) Ltd., has received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) ...
2025-07-31 17:55
2710
Akeso Announces Completion of First Dosing in Phase III Clinical Trial of Ivonescimab (PD-1/VEGF) Combination Therapy for Immunotherapy-Resistant NSCLC
HONG KONG, July 30, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") announced that the first patient has been dosed in its pivotal Phase III clinical study (AK112-305/HARMONi-8A) of ivonescimab (PD-1/VEGF bispecific antibody) in combination with docetaxel for the treatment o...
2025-07-31 09:46
2124
BON Launches AI-Powered New Drug Research and Development
XI'AN, China, July 30, 2025 /PRNewswire/ -- Bon Natural Life Limited (Nasdaq: BON) ("BON" or "the Company"), a leading provider of bio-ingredient solutions for the natural health and personal care industries, today announced the official launch of its AI-driven drug research and development (R&D)...
2025-07-30 21:00
3180
Emerald Clinical Trials Confirms CEO Transition and Continuity Plan
SINGAPORE, July 30, 2025 /PRNewswire/ -- Emerald Clinical Trials, a leading global clinical research organization, today announced a leadership transition. Mary Gunn has stepped down effective immediately. The Board has appointedGlenn Kerkhof, a long-standing Board member and experienced CRO exec...
2025-07-30 20:00
2612
Dx&Vx Signs USD 220 Million Co-Development and License Agreement for mRNA Cancer Vaccine with U.S. Biotech Company
- First global out-licensing deal since founding — tangible return on new drug development investments - Significant milestone payments and future revenue expected — additional out-licensing of proprietary technologies anticipated SEOUL, South Korea, July 30, 2025 /PRNewswire/ -- Dx&Vx (DXVX) ha...
2025-07-30 20:00
2689
Harbour BioMed to Present Phase II Data of HBM4003 and Tislelizumab Combination in MSS Metastatic Colorectal Cancer at ESMO 2025
CAMBRIDGE, Mass., ROTTERDAM, Netherlands and SHANGHAI, July 29, 2025 /PRNewswire/ -- Harbour BioMed (HKEX: 02142), a global biopharmaceutical company focused on the discovery and development of novel antibody therapeutics in immunology and oncology, today announced that it will present Phase II ...
2025-07-30 08:01
2366
Telix H1 2025 Results: Investor Webcast Notification
MELBOURNE, Australia and INDIANAPOLIS, July 30, 2025 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, "Telix") today advises that it will release its financial results for the half-year ended30 June 2025 on Thursday21 August 2025. An investor webcast and conference call wi...
2025-07-30 07:00
3377
Kyowa Kirin Announces Abstract Presentation at the European Academy of Dermatology and Venereology (EADV) Congress
PRINCETON, N.J. and TOKYO, July 29, 2025 /PRNewswire/ -- Kyowa Kirin Co., Ltd. (TSE: 4151) today announced that results of the Phase 3 ROCKET IGNITE trial of rocatinlimab, an investigational therapy targeting the OX40 receptor (OX40R) in patients with moderate-to-severe atopic dermatitis (AD), wi...
2025-07-29 20:00
2216
Alphamab Oncology Announces Anti-HER2 Biparatopic ADC JSKN003 Obtained Orphan Drug Designation from the U.S. FDA for the Treatment of GC/GEJ
SUZHOU, China, July 29, 2025 /PRNewswire/ -- Alphamab Oncology (stock code: 9966.HK) announced that anti-HER2 biparatopic antibody-drug conjugate (ADC) JSKN003 has been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) for the treatment of gastric cancer and ga...
2025-07-29 10:37
2219
Antengene Announces XPOVIO® Approved in China for the Second-Line Treatment of Multiple Myeloma, Marking the Third Approved Indication of the Drug
- This approval for XPOVIO® in combination with bortezomib and dexamethasone (XVd) for the treatment of adult patients with multiple myeloma (MM) who have received at least one prior therapy marks the third approved indication of the drug inChina. - XPOVIO® as a monotherapy in patients with relap...
2025-07-28 18:49
2810
Caliway Announces FDA Clearance of IND Application for CBL-514 to Proceed with SUPREME-01, the First Global Pivotal Phase 3 Study for Reducing Abdominal Subcutaneous Fat
* CBL-514, Caliway's first-in-class lipolysis drug candidate, has been granted clearance from the U.S. FDA to proceed with SUPREME-01, a global, multicenter, pivotal Phase 3 study. Subject recruitment is expected to begin in the U.S. andCanada in Q3 2025. * CBL-514 is the first 505(b)(1) inve...
2025-07-28 17:51
2206
Successful Completion of First CRS with HIPEC on a 60-year-old Woman with Advanced Peritoneal Carcinomatosis
KOLKATA, India, July 28, 2025 /PRNewswire/ -- In a landmark achievement, a 60-year-old woman with advanced primary peritoneal carcinomatosis was successfully treated withCytoreductive Surgery (CRS) combined with Hyperthermic Intraperitoneal Chemotherapy (HIPEC)at Manipal Hospital Dhakuria, under ...
2025-07-28 15:20
1807
Alteogen Receives Positive CHMP Opinion for Aflibercept Biosimilar, 'EYLUXVI® (ALT-L9)'
* CHMP positive opinion is based on a robust analytical, non-clinical and clinical data package comparing EYLUXVI® to the reference product Eylea® * Upon approval, EYLUXVI® will be Alteogen's second biosimilar product, following a Herceptin® biosimilar by Alteogen's license partner Qilu Pharm...
2025-07-28 14:00
2790
NMPA Accepts sNDA for Ivonescimab in Combination with Chemotherapy as First-Line Treatment for Advanced Squamous Non-Small Cell Lung Cancer
HONG KONG, July 28, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") is pleased to announce that the National Medical Products Administration (NMPA) has accepted the supplementary New Drug Application (sNDA) for ivonescimab (PD-1/VEGF bispecific antibody) in combination with ...
2025-07-28 12:14
3738
Antengene Announces Poster Presentation of ATG-022 (Claudin 18.2 ADC) at ESMO 2025
SHANGHAI and HONG KONG, July 28, 2025 /PRNewswire/ -- Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercialising first-in-class and/or best-in-class medicines for canc...
2025-07-28 10:40
2120
Ascletis Announces First Participants with Obesity or Overweight Dosed in Its U.S. 12-week Phase IIa Study Evaluating Once-Monthly Subcutaneous Depot Formulation of Small Molecule GLP-1R Agonist ASC30
- First participants with obesity or overweight with at least one w eight-related comorbidity have been dosed in a U.S. 12-week Phase IIa study with once-monthly subcutaneous (SQ) depot formulation of small molecule GLP-1 receptor agonist ASC30. - Ultra-long-acting SQ depot for...
2025-07-28 08:15
2287
Harbour BioMed Announces Positive Profit Alert for 2025 Interim Results
CAMBRIDGE, Mass., ROTTERDAM, Netherlands and SHANGHAI, July 27, 2025 /PRNewswire/ -- Harbour BioMed (the "Company"; HKEX: 02142), a global biopharmaceutical company focused on the discovery and development of novel antibody therapeutics in immunology and oncology, today announced a positive prof...
2025-07-28 08:11
2542
Elpis Biopharmaceuticals Signs Memorandum of Understanding with National Cancer Centre Singapore to Conduct Translational Cell Therapy Research in Singapore
Collaboration focuses on advancing clinically validated armored CAR technologies into first-in-human trials inSingapore and accelerate translational research from bench-to-bedside SINGAPORE and LEXINGTON, Mass., July 28, 2025 /PRNewswire/ -- Elpis Biopharmaceuticals, a clinical-stage cell therap...
2025-07-28 07:33
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