Pharmaceuticals
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
1740
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
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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
1865
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
3551
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
1931
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
2031
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
2163
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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Phase II Stage Of Pivotal Clinical Trial Of KX-826 Tincture 1.0% For The Treatment Of Male Adult Aga In China Reached Primary Endpoint
SUZHOU, China, July 26, 2025 /PRNewswire/ -- The Kintor Pharmaceutical Limited (the "Company") is pleased to announce that the Phase II Stage of the Pivotal Clinical Trial of its in-house developed and potential first-in-class KX-826 tincture 1.0% for the treatment of AGA has obtained top-line re...
2025-07-26 07:30
4050
Shanton Receives Fast Track Designation from US FDA for Refractory Gout Program
SAP-001 is Shanton's lead investigational compound with First- and Best-in-Class potential in uncontrolled gout SINGAPORE and PRINCETON, N.J., July 25, 2025 /PRNewswire/ -- Shanton Pharma, a clinical-stage biotech company developing a novel treatment for gout, today announced that FDA has design...
2025-07-25 22:59
3802
Phase II Stage Of Pivotal Clinical Trial Of KX-826 Tincture 1.0% For The Treatment Of Male Adult Aga In China Reached Primary Endpoint
SUZHOU, China, July 25, 2025 /PRNewswire/ -- The Kintor Pharmaceutical Limited (the "Company") is pleased to announce that the Phase II Stage of the Pivotal Clinical Trial of its in-house developed and potential first-in-class KX-826 tincture 1.0% for the treatment of AGA has obtained top-line re...
2025-07-25 20:30
3435
Everest Medicines Announces Share Placement to Raise Approximately HK$1,572.50 Million
SHANGHAI, July 25, 2025 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK, "Everest" or the "Company"), a biopharmaceutical company focused on the discovery, clinical development, manufacturing, and commercialization of innovative therapeutics, today announced that it has entered into a placing and...
2025-07-25 10:30
3014
Colorcon Celebrates Grand Opening of New Manufacturing Facility in Malaysia
Johor plant is Colorcon's 7th major film coating plant and 16th manufacturing facility worldwide HARLEYSVILLE, Pa. and JOHOR, Malaysia, July 24, 2025 /PRNewswire/ -- Colorcon, a global leader of film coating systems, specialty excipients, controlled release formulations and controlled atmosphere...
2025-07-24 22:00
2985
AMSC Malaysia 2025 Set to Spotlight World-Class Expertise and Innovation in Aesthetic Medicine and Surgery
KUALA LUMPUR, Malaysia, July 24, 2025 /PRNewswire/ -- The Aesthetic Medicine &
Surgery Conference & Exhibition (AMSC)
2025-07-24 20:24
3942
Seegene unveils the world's first unattended PCR automation, igniting a global diagnostic paradigm shift at ADLM 2025
* Fully Unmanned— CURECA™, the 100% Automated Diagnostic System Defining the Future Gold Standard, Debuts inChicago, July 28–31 * Unifying global diagnostic data - STAgora™, the big data platform set to transform the future of diagnostics * Offering early access to the new diagnostic parad...
2025-07-24 17:36
2329
Akeso Announces First Patient Enrollment in Phase III Trial of Ivonescimab for Pancreatic Cancer
HONG KONG, July 23, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") is pleased to announce that the first patient has been enrolled in the pivotal/registration Phase III clinical trial (AK112-310/HARMONi-GI2) of ivonescimab, a first-in-class PD-1/VEGF bispecific antibody dev...
2025-07-24 09:14
1455
HBM9378/WIN378, a Long-Acting, Fully Human Anti-TSLP Antibody, Enters Global Phase 2 POLARIS Trial for Asthma
* Phase 2 POLARIS trial will evaluate the dosing, safety, and efficacy of HBM9378/WIN378 in patients with asthma, with an initial data readout expected in mid-2026 * HBM9378/WIN378 has the potential to be the first-to-market long-acting anti-TSLP antibody with twice-yearly dosing for asthma ...
2025-07-23 20:36
2195
Samsung Biologics reports second quarter 2025 financial results
* Recorded Q2'25 consolidated revenue of KRW 1,289.9 billion * Recorded Q2'25 consolidated operating profit of KRW 475.6 billion * Solid momentum sustained through capacity ramp-up and stable project execution INCHEON, South Korea, July 23, 2025 /PRNewswire/ -- Samsung Biologics (KRX: 207940...
2025-07-23 14:54
2168
Telix Reports $204M Revenue, Up 63% YOY
MELBOURNE, Australia and INDIANAPOLIS, July 22, 2025 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, "Telix") today provides an update on its commercial and operational performance for the quarter ended30 June 2025 (Q2 2025). All figures are in USD unless stated otherwise. ...
2025-07-22 16:02
2569
METiS Technologies Showcases AI-Powered Nanodelivery Platform at the 2025 Controlled Release Society Annual Meeting
HANGZHOU, BEIJING, China and CAMBRIDGE, Mass., July 22, 2025 /PRNewswire/ -- METiS Technologies, a global leader in AI-driven nanodelivery innovation, today announced the presentation of its latest research findings at the poster session of the 2025 Controlled Release Society (CRS) Annual Meeting...
2025-07-22 15:52
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