Clinical Trial News
CDSCO Approves AstraZeneca's Protocol Amendments for Durvalumab-Tremelimumab Combination in Advanced Liver Cancer
• India's CDSCO expert committee has approved AstraZeneca's protocol amendment for a Phase III trial evaluating durvalumab and tremelimumab combination as first-line treatment for advanced hepatocellular carcinoma.
• The approval follows AstraZeneca's presentation of protocol amendment version 8.0 dated June 17, 2024, allowing the company to proceed with modifications to their ongoing clinical investigation.
• This development comes alongside CDSCO's separate approval of AstraZeneca's protocol amendment for AZD0901, an antibody-drug conjugate being studied in advanced gastric cancer expressing claudin18.2.
Pfizer Receives CDSCO Approval for Phase 3 Trial of HER2-Targeting ADC Disitamab Vedotin
• India's CDSCO expert panel has granted Pfizer conditional approval to conduct Phase 3 clinical trials of Disitamab Vedotin, an antibody-drug conjugate targeting HER2-positive solid tumors.
• The approval requires Pfizer to include more geographically distributed government sites across India and mandates that principal investigators must be medical oncologists.
• Disitamab Vedotin (RC48) combines a HER2-targeting monoclonal antibody with cytotoxic agent monomethyl auristatin E (MMAE), showing promise for gastric and urothelial cancers.
FDA Accepts Sparsentan sNDA for Full Approval in Focal Segmental Glomerulosclerosis
• The FDA has accepted Travere Therapeutics' supplemental New Drug Application for traditional approval of sparsentan (Filspari) in focal segmental glomerulosclerosis, with a decision expected by January 2026.
• An FDA advisory committee meeting will be convened to review the application data, signaling the regulatory importance of this potential treatment option for FSGS patients.
• If approved, sparsentan would strengthen treatment options for FSGS, a rare kidney disorder with limited therapeutic alternatives and significant unmet medical needs.
USFDA Issues Form 483 with Two Observations for Dr. Reddy's New York API Facility
• The U.S. Food and Drug Administration completed a Good Manufacturing Practice inspection at Dr. Reddy's Middleburgh API facility in New York, resulting in two observations via Form 483.
• The inspection was conducted from May 12-16, 2025, with Dr. Reddy's committing to address the observations within the stipulated timeline set by regulators.
• Form 483 is issued when FDA investigators observe conditions that may constitute violations of the Food Drug and Cosmetic Act, potentially affecting the company's manufacturing compliance status.
Silo Pharma Secures $2 Million in Public Offering to Advance CNS and Pain Therapeutics
• Silo Pharma has successfully closed a $2 million public offering, issuing over 3.3 million shares of common stock along with Series A-1 and A-2 warrants at $0.60 per share.
• The biopharmaceutical company plans to use the proceeds for general working capital to support its developmental pipeline, which includes SPC-15 for PTSD and SP-26 for fibromyalgia and chronic pain.
• H.C. Wainwright & Co. served as the exclusive placement agent for the offering, which was conducted through a registration statement declared effective by the SEC on May 15, 2025.
Sylentis Reports Positive Phase IIa Results for SYL1801 Eye Drops in Age-Related Macular Degeneration
• Sylentis announced that SYL1801, an investigational siRNA therapy administered as eye drops, met its primary endpoint in a Phase IIa study for neovascular age-related macular degeneration (nAMD).
• Over 71% of patients receiving the mid-dose level maintained visual acuity throughout the 6-week study period, with this dose achieving statistically significant improvement in visual acuity at day 42.
• SYL1801 represents a potential paradigm shift in AMD treatment, as it could replace uncomfortable intravitreal injections with a more patient-friendly eye drop formulation based on RNA interference technology.
Highlighted Clinical Trials:
Sylentis, S.A.
Posted 5/18/2017
Alzheimer's Drug Discovery Foundation Partners with Siemens Healthineers to License SpeechDx Dataset for Speech-Based Biomarker Development
• The Alzheimer's Drug Discovery Foundation's Diagnostics Accelerator has partnered with Siemens Healthineers to license the SpeechDx dataset, marking the first commercial partnership for this gold-standard speech and clinical data collection.
• SpeechDx represents the largest longitudinal dataset combining harmonized speech, clinical, and biomarker data from approximately 2,000 participants across eight clinical sites, collected in three languages over three years.
• The partnership aims to develop speech-based biomarkers that could detect Alzheimer's disease 20-30 years before symptoms appear, potentially transforming early diagnosis through accessible technology like smartphones and computers.
• Data collection is scheduled to complete in 2028, with initial data releases to partners beginning in 2025, supporting the development of novel diagnostic and prognostic tools for Alzheimer's disease.
Panjab University Patents Breakthrough Green Nanomicelle Platform for Pharmaceutical and Skincare Applications
• Panjab University has filed Indian and international patents for an eco-friendly nanomicelle platform that enables targeted delivery of sensitive bioactives including peptides, cannabinoids, and proteins.
• The innovative technology, developed by Professor Indu Pal Kaur and her PhD scholars, features a solvent-free, room-temperature process that maintains scalability while supporting clean-label product development.
• The platform has already been commercialized in the skincare sector through technology transfer to an industrial partner, demonstrating its potential across pharmaceuticals, nutraceuticals, and wellness industries.
Brain Cancer Canada Funds $68,000 for Innovative DIPG Vaccine Clinical Trial
• Brain Cancer Canada has awarded $68,000 to researchers at the University of Calgary and Alberta Children's Hospital for a clinical trial of a neoantigen-based anti-cancer vaccine targeting DIPG, the most aggressive form of pediatric brain cancer.
• The research, led by Dr. Aru Narendran and Dr. Patrick Sipila, aims to train patients' immune systems to recognize and eliminate tumor cells, potentially offering new hope for a disease with fewer than 10% of children surviving two years post-diagnosis.
• The announcement coincides with DIPG Awareness Day, with landmarks across Canada illuminated in yellow to raise awareness for this devastating pediatric brain cancer that has seen little improvement in survival rates despite decades of cancer research advances.
Kakao Healthcare Expands AI-Powered Glucose Monitoring App to Japanese Market
• Kakao Healthcare Corp. is launching its AI-powered continuous glucose monitoring app PASTA in Japan through a new subsidiary, marking a significant step in the company's global expansion strategy.
• PASTA integrates with CGM sensors from I-sens Inc.'s Caresens Air and Dexcom Inc.'s G7 system, providing advanced diabetes management capabilities through artificial intelligence technology.
• The expansion follows Kakao's recent initiatives in data-driven healthcare, including plans to develop an "AI-platform bridge" connecting medical institutions, government, and industry for drug discovery and research.