Biotechnology
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
1973
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
2347
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
2417
Nona Biosciences Integrates Cutting-Edge AI Technology to Enhance Its Fully Human Antibody Platform, Accelerating Antibody Discovery Across Key Therapeutic Areas
CAMBRIDGE, Mass., March 7, 2025 /PRNewswire/ -- Nona Biosciences, a global biotechnology company providing integrated solutions from "Idea to IND" (I to I TM), today announced to unveil its innovative AI-assisted drug discovery engine, Hu-mAtrIxTM. This new platform, powered by advanced artificial ...
2025-03-07 14:00
1901
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
1693
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
2153
Newly-formed Archerfish Precision Diagnostics Pte Ltd: Ushers a New Era in Advanced Diagnostics
SINGAPORE, March 5, 2025 /PRNewswire/ -- In a significant development for the clinical diagnostics landscape inSingapore, Angsana Molecular & Diagnostics Laboratory (Angsana) and Pathnova Laboratories (Pathnova) have announced their merger to formArcherfish Precision Diagnostics Private Limited (...
2025-03-05 22:00
2413
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
2647
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
2025
Bioheng Therapeutics Announces FDA Clearance of IND Application for CD7 UCAR T Cell Therapy in T-ALL/LBL
BOSTON, March 5, 2025 /PRNewswire/ -- Bioheng Therapeutics US LLC ("Bioheng"), a clinical-stagebiotech company dedicated to developing innovative universal CAR-T cell therapies, today announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) appli...
2025-03-05 14:49
1903
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
2137
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
2396
WuXi Biologics Launches EffiX™ Microbial Expression Platform to Boost Recombinant Protein and Plasmid DNA Production
- EffiX™ is designed to meet the industry's demand for a high-yield, stable, and non-lysogenicE. coli expression system. It serves as a comprehensive solution for the development and manufacturing of non-monoclonal antibody (non-mAb) recombinant proteins and plasmid DNA for clients acros...
2025-03-04 08:30
2078
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
3066
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
2075
BioRes Ruizhi BLC Implant System Showcased in China, Addressing Rising Demand for High-quality Implants
WALNUT, Calif., March 3, 2025 /PRNewswire/ -- BioRes Dentech Inc. showcased its Ruizhi BLC Implant System at Dental South China 2025, a premium product line jointly launched by BioRes Dentech Inc. and Besmile, designed exclusively for China's market. With advanced bone preservation technology and ...
2025-03-03 15:00
1775
CARsgen's Claudin18.2 CAR-T Therapy Satri-cel Granted Breakthrough Therapy Designation by the NMPA
SHANGHAI, March 2, 2025 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, announces that the Center for Drug Evaluation (CDE) ofChina's National Medical ...
2025-03-03 08:15
2258
Breakthrough! Exciting interim Phase II Data of LP-003 in CSU released by Longbio at AAAAI 2025
SAN DIEGO, March 2, 2025 /PRNewswire/ -- Longbio Pharma (Suzhou) Co., Ltd. (referred to as "Longbio"), a leading biotech company dedicated to developing innovative biologic treatments for allergy, respiratory, dermatology, hematology, ophthalmology, and other autoimmune and rare diseases, proudly...
2025-03-03 02:00
1807
Bambusa Therapeutics Announces First Subject Dosed in Phase 1 Clinical Trial of BBT001, a Novel Multi-Targeting, Half-Life Extended Bispecific Antibody for the Treatment of Atopic Dermatitis and Other Inflammatory Skin Diseases
Preclinical data with BBT001 demonstrate its best-in-disease potential for improved efficacy and dosing convenience compared to approved biologics in atopic dermatitis Interim safety and pharmacokinetic data from healthy volunteers anticipated in 2H 2025 BOSTON, Feb. 28, 2025 /PRNewswire/ -- Ba...
2025-02-28 22:58
4524
Fapon Biopharma Announces FDA Approval of IND for FP008, a First-in-Class Immunotherapy for Solid Tumors
DONGGUAN, China, Feb. 28, 2025 /PRNewswire/ -- Fapon Biopharma, a biotech innovator in developing therapeutic antibodies and fusion proteins, is pleased to announce that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for FP008, its first-in...
2025-02-28 16:39
2082
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