Clinical Trial News
DexTech Medical Secures European Patent for OsteoDex GMP Manufacturing Until 2045
• DexTech Medical has received European patent approval for the GMP manufacturing process of OsteoDex, their lead candidate for treating castration-resistant prostate cancer.
• The newly granted patent extends market exclusivity until 2045, significantly strengthening the company's position in ongoing partnership and licensing negotiations.
• This patent approval represents a critical milestone for the continued clinical development of OsteoDex following its completed Phase 2 trials.
Taiwan Approves Chugai's PiaSky as First Subcutaneous Treatment for Paroxysmal Nocturnal Hemoglobinuria
• Taiwan FDA has granted orphan drug approval for PiaSky, making it the first subcutaneous treatment for paroxysmal nocturnal hemoglobinuria (PNH) available in Taiwan for patients 13 years and older.
• PiaSky, developed with Chugai's proprietary Recycling Antibody technology, allows for convenient subcutaneous administration every 4 weeks, significantly reducing treatment burden compared to existing biweekly intravenous options.
• The approval was based on positive results from three Phase III clinical trials, including COMMODORE 2, which demonstrated efficacy in transfusion avoidance and control of hemolysis compared to eculizumab.
Massalia Therapeutics Launches with Seed Funding to Target Fibrosis-Neoplasm-Neovascularization Interface
• Massalia Therapeutics has launched as a biotechnology spin-off from Aix-Marseille University's C2VN Institute, backed by seed financing to develop its novel SANF factor therapeutic platform.
• The company's proprietary SANF (Soluble Angiogenic Neoplastic and Fibrotic) factor targets the critical intersection of fibrosis, neoplasm, and neovascularization, representing a potential paradigm shift in treatment approaches.
• With preclinical testing complete, Massalia plans to begin first-in-human trials within six months and advance toward IND-enabling studies, leveraging 20 years of research by co-founders Dr. Marcel Blot-Chabaud and Professor Nathalie Bardin.
Regeneron to Acquire 23andMe for $256 Million, Expanding Genetics-Driven Drug Discovery Capabilities
• Regeneron Pharmaceuticals has won the bankruptcy auction for 23andMe's assets with a $256 million bid, aiming to maintain the consumer genetics service while enhancing its drug discovery platform.
• The acquisition includes 23andMe's Personal Genome Service, Total Health, Research Services, and Biobank assets, but excludes the Lemonaid Health business.
• Regeneron has committed to prioritizing privacy and ethical use of customer data, working with a court-appointed Customer Privacy Ombudsman to ensure compliance with existing policies.
AKANTIOR® Receives UK Marketing Authorization as First Approved Treatment for Acanthamoeba Keratitis
• SIFI's AKANTIOR® (polihexanide 0.08%) has received both Marketing Authorization and Promising Innovative Medicine designation from the UK's MHRA, marking it as the first approved treatment for Acanthamoeba keratitis.
• The approval confirms AKANTIOR's Orphan Drug Designation and New Active Substance status, recognizing its efficacy against an ultra-rare corneal infection that can lead to blindness if untreated.
• Following its European approval in August 2024, this UK authorization represents a significant advancement for patients with this devastating eye infection, with SIFI planning to file for NICE reimbursement by June 2025.
FDA Approves 18 New Personalized Medicines in 2024, Marking Significant Shift in Treatment Paradigm
• The FDA approved 18 new personalized medicines in 2024, representing 38% of all newly approved therapeutic molecular entities across multiple treatment areas including cancer and Alzheimer's disease.
• Six new gene and cell-based therapies for rare genetic diseases and cancers were authorized, alongside expanded indications for 11 diagnostic testing systems and the first-ever expanded indication for an approved gene therapy.
• Personalized medicines now constitute at least 25% of drug approvals for the past decade, a substantial increase from less than 10% ten years ago, demonstrating the healthcare system's shift away from one-size-fits-all approaches.
VESALIUS-REAL Study Reveals Critical Gaps in Cardiovascular Care Despite Available Treatments
• The VESALIUS-REAL study of 278,000 high-risk patients found 70% did not receive lipid-lowering therapy after heart attacks or strokes, and 88% had no treatment intensification within a year.
• Half of cardiovascular event patients never received follow-up LDL-C testing, and among those tested, 82% failed to achieve guideline-recommended cholesterol goals despite available treatments.
• Amgen is working to address these care gaps through initiatives including free LDL-C testing at CVS MinuteClinics, partnerships with cardiology organizations, and the LATTICE Consortium to accelerate implementation science.
Merck and Daiichi Sankyo Launch Phase 3 Trial of Novel B7-H3 Targeted ADC for Advanced Esophageal Cancer
• The IDeate-Esophageal01 Phase 3 trial has begun evaluating ifinatamab deruxtecan, a potential first-in-class B7-H3 directed antibody-drug conjugate, against standard chemotherapy in advanced esophageal squamous cell carcinoma.
• Esophageal squamous cell carcinoma accounts for 90% of global esophageal cancers with dismal survival rates of 15-20%, highlighting the urgent need for new treatment approaches after first-line therapy failure.
• The trial follows promising early-phase results and will enroll approximately 510 patients across Asia, Europe, and North America, with overall survival as the primary endpoint.
Highlighted Clinical Trials:
Daiichi Sankyo
Posted 3/9/2022
Daiichi Sankyo
Posted 11/3/2019
Daiichi Sankyo
Posted 3/27/2025
Daiichi Sankyo
Posted 5/21/2024
Daiichi Sankyo
Posted 4/10/2024
Cipla Receives VAI Status from USFDA for Two Manufacturing Facilities
• Cipla's Goa API facility and Sitec Labs' Mahape analytical testing facility have both received Voluntary Action Indicated (VAI) status from the USFDA following recent inspections.
• The Goa Medispray facility inspection concluded with one observation in Form 483, while the Mahape facility received two observations during its February 2025 inspection.
• The VAI classifications allow both facilities to continue operations while addressing the minor compliance issues identified by regulators, representing positive regulatory outcomes for the global pharmaceutical company.
New Mainland Chinese Cancer Drug Shows Promising Results in Phase 1 Trial
• A multinational study led by Chinese University of Hong Kong researchers found that D3S-001, a mainland-developed cancer drug, effectively treats tumors driven by KRAS-G12C gene mutations.
• The phase 1 trial demonstrated remarkable efficacy with over 70% of the 42 participating patients experiencing significant tumor shrinkage or complete disappearance after treatment.
• Researchers noted that D3S-001 inhibits the KRAS-G12C mutation more quickly and potentially for longer durations than existing first-generation inhibitors, showing promise for non-small-cell lung, colorectal, and pancreatic cancers.