AccurEdit Therapeutics’ ART001 Becomes China’s First Gene Editing Therapy to Receive FDA Regenerative Medicine Advanced Therapy (RMAT) Designation
RMAT designation expected to expedite development; 72 weeks interim clinical trial data showing sustainable reduction of TTR over 90% with no significant adverse events. SUZHOU, China, May 29, 2025 /PRNewswire/ -- AccurEdit Therapeutics today announced that its internally developed in vivo gene editing therapy ART001 has been granted a Regenerative Medicine Advanced Therapy...
Neuronata-R® Stem Cell Therapy Shows Promise in ALS Phase 3 Subgroup Analysis, Moves Toward FDA Accelerated Approval
Meaningful efficacy observed in slow-progressor subgroup; NfL biomarker improvements support potential for accelerated regulatory pathway SEOUL, South Korea, May 29, 2025 /PRNewswire/ -- Neuronata-R®, an autologous bone marrow-derived mesenchymal stem cell (MSC) therapy for amyotrophic lateral sclerosis (ALS), has demonstrated meaningful efficacy signals in a subgroup of participants with slow disease progression in its recently completed Phase 3...
Rona Therapeutics Announces Breakthrough Data on Potential Annual Dosing RNAi Therapy RN026 Targeting Lipoprotein(a) in The National Lipid Association (NLA) Scientific Sessions 2025
SHANGHAI, May 29, 2025 /PRNewswire/ -- Rona Therapeutics, a global leading RNA therapy company, today announced preclinical data for its self-developed RNA interference (RNAi) therapy RN026 at the National Lipid Association (NLA) Annual Scientific Sessions. Preclinical studies revealed that the therapy, targeting lipoprotein(a) (Lp(a))—an independent risk factor for cardiovascular diseases—achieved a 99% reduction in Lp(a) with potential annual dosing regimen...
tHIS ASEAN 2025 to Debut in Kuala Lumpur, Uniting Southeast Asia’s Healthcare Powerhouses
KUALA LUMPUR, Malaysia, May 29, 2025 /PRNewswire/ -- The Health Industry Series - ASEAN (tHIS ASEAN 2025), a groundbreaking event aimed at integrating healthcare resources across Southeast Asia, is set to take place in Kuala Lumpur during June 9-11. Co-located with the APHM International Healthcare Conference & Exhibition 2025, hosted by the Association of Private Hospitals of Malaysia...
Acclaro Medical Raises $23 Million in Series B Funding Led by Accelmed Partners to Advance Groundbreaking 2910 nm Fiber Laser Technology
Accelmed $20 Million Investment with 3E Bioventures Capital Funding of $3 Million to Drive Innovation, Clinical Expansion, and Global Market Growth SMITHFIELD, R.I., May 29, 2025 /PRNewswire/ -- Acclaro Medical, a pioneering medical technology company focused on developing cutting-edge solutions that improve patient care and...
AI Meets Audit Powerhouse: Qualifyze Launches Quality Insights Platform to Help Global Pharma Manage Supplier Site Risk
FRANKFURT, Germany, May 29, 2025 /PRNewswire/ -- Qualifyze, already the global leader in third-party audit services for the pharmaceutical industry, announces the launch of Quality Insights Platform, an AI-powered platform that transforms the world's largest pharmaceutical audit database into a strategic risk management tool. Quality Insights Platform: Real-time site...
China’s HER2-Targeted ADC Trastuzumab Rezetecan Gains NMPA Approval for HER2-Mutant NSCLC
SHANGHAI, May 29, 2025 /PRNewswire/ -- The National Medical Products Administration has recently granted approval for Trastuzumab rezetecan, China's first domestically developed antibody-drug conjugate (ADC), for treatment of adult patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring activating HER2 (ERBB2) mutations who have previously received at least one systemic therapy. The approval of Trastuzumab rezetecan was based on...
The Brain Prize: HM The King of Denmark presents prestigious prize to US and German scientists for seminal discoveries in brain cancer
Two pioneering scientists received The Brain Prize 2025 for their discoveries that open an entirely new way of thinking about and understanding brain cancers, and the potential strategies to treat them. COPENHAGEN, Denmark, May 29, 2025 /PRNewswire/ -- HM King Frederik of Denmark presented neuroscientists, Professors Michelle Monje (USA) and Frank Winkler (Germany), with...
CPHI & PMEC China Sees Surge in International Attendance as Global Pharma Trade Outlook Strengthens
Record international participation reflects renewed momentum in pharma manufacturing and global sourcing, as easing tariffs fuel growth SHANGHAI, May 29, 2025 /PRNewswire/ -- CPHI & PMEC China (June 24-26th) returns to the Shanghai New International Expo Center amid a marked surge in international interest, with industry momentum rebounding following a string of positive developments in global trade and pharmaceutical investment....
Kexing Biopharm’s GB18 project received clearance of IND application from NMPA and FDA
SHENZHEN, China, May 29, 2025 /PRNewswire/ -- On May 26th, Kexing Biopharm (688136.SH) announced that the National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) application for its independently developed innovative product, GB18. Moreover, GB18 has previously received the clearance from U.S. Food and Drug Administration (FDA) for IND application on May 21st. GB18 is an innovative biologic...
