September 2025 - Page 4 of 4 - BioMedWire (BMW)

WednesdaySep 03, 2025 9:45 am

Oncotelic Therapeutics Inc. (OTLC) Is ‘One to Watch’

The company’s lead candidate, OT-101, is currently in a Phase 3 trial for pancreatic cancer and is advancing toward combination studies with checkpoint inhibitors. A joint venture with GMP Biotechnology enables Oncotelic to conduct low-cost research and development, operate in-house GMP manufacturing, and support a rapidly expanding nanoparticle pipeline trademarked Deciparticle(TM). A strategic partnership with Shanghai Medicilon supports rapid IND filings for up to 20 drug candidates, significantly accelerating development timelines. Oncotelic’s proprietary AI platform, PDAOAI, enhances regulatory and research workflows while offering public engagement tools for added transparency. The company maintains a multi-indication pipeline spanning oncology, Parkinson’s disease, erectile…

TuesdaySep 02, 2025 12:00 pm

Izotropic Corporation (CSE: IZO) (OTCQB: IZOZF): Building Market Awareness Through Strategic Education Platform

BreastCT.com launches as a comprehensive educational resource focused on dedicated breast CT technology and IzoView's clinical advantages for dense breast tissue imaging Platform designed to evolve alongside company progression through clinical studies, regulatory phases, and commercial launch milestones Strategic positioning within successful imaging category creation context provides clear market reference framework for IzoView's commercial potential The Pre-Commercial Challenge: Educating Markets on Breakthrough Technology Medical device companies developing breakthrough technologies face a fundamental commercialization challenge beyond regulatory approval: market education. When innovations represent genuine advances over existing standards of care, successful adoption requires comprehensive stakeholder education across patients, clinicians, and healthcare…

TuesdaySep 02, 2025 9:00 am

NRx Pharmaceuticals Inc. (NASDAQ: NRXP) Secures FDA Fast Track for IV Ketamine Formulation NRX-100 in Suicidal Depression

The FDA designation expands the drug’s potential patient pool tenfold, to an estimated 13 million Americans who consider suicide annually. Clinical trials demonstrated rapid and statistically significant reductions in suicidal ideation with IV ketamine versus placebo and comparators. Fast Track status makes NRX-100 eligible for Accelerated Approval and the Commissioner's National Priority Voucher program. NRx is preparing an expanded access policy and seeking meetings with FDA leadership to align on data submission. The U.S. suicidal depression market is estimated at more than $3 billion annually. NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, announced that the U.S. Food and Drug…