BioMedNewsBreaks

FridayJun 06, 2025 2:00 pm

BioMedNewsBreaks — Why Intelligent Bio Solutions Inc. (NASDAQ: INBS) Is ‘One to Watch’

Intelligent Bio Solutions (NASDAQ: INBS) is a medical technology company pioneering rapid, non-invasive diagnostics through its proprietary Intelligent Fingerprinting Drug Screening System. INBS was featured in a recent article that reads, “By utilizing fingerprint sweat analysis, the company offers a cost-effective, hygienic solution to detect recent drug use — targeting substances commonly found in workplace settings… The company’s vision is to redefine drug screening by removing the pain points of traditional testing methods, including biohazardous waste, privacy concerns, and long result turnaround times. With results in under 10 minutes and no need for gender-specific collectors or laboratory facilities, the system empowers…

Continue Reading

FridayJun 06, 2025 11:34 am

BioMedNewsBreaks — FDA Accelerates Launch of AI Tool Elsa, Raising Questions on Transparency and Oversight 

The U.S. Food and Drug Administration (“FDA”) has fast-tracked the rollout of its AI tool, Elsa, originally planned for June 30, with Commissioner Dr. Marty Makary touting the launch as both “ahead of schedule and under budget.” Elsa is already streamlining workflows across the agency, reducing multiday review tasks to minutes, and handling administrative functions such as safety profile assessments, label comparisons, and protocol reviews. The tool is housed in a secure GovCloud environment and was not trained on industry-submitted data, according to Makary. Still, the launch has raised questions about transparency, validation, and long-term oversight. Some FDA staff reportedly…

Continue Reading

ThursdayJun 05, 2025 1:38 pm

BioMedNewsBreaks — Calidi Biotherapeutics Inc. (NYSE American: CLDI) Unveils Promising Data on CLD-401 at ASCO 2025

Calidi Biotherapeutics (NYSE American: CLDI) is a clinical-stage biotechnology company pioneering the development of systemic oncolytic targeted immunotherapies with the ability to deliver genetic payloads. The company unveiled promising new data on its lead RedTail platform candidate, CLD-401, at the American Society of Clinical Oncology (“ASCO”) Annual Meeting. The announcement reads, “Calidi has previously demonstrated its pioneering efforts in developing an enveloped form of its proprietary oncolytic virus that is significantly more resistant to immune clearance than non-enveloped forms, allowing for systemic delivery and efficacy in syngeneic tumor-bearing pre-clinical models. Calidi has further advanced this technology with CLD-401, its first…

Continue Reading

ThursdayJun 05, 2025 1:16 pm

BioMedNewsBreaks — NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) Files ANDA for Preservative-Free IV Ketamine, Targets Expanding $750M Market 

NRx Pharmaceuticals (NASDAQ: NRXP), has submitted an Abbreviated New Drug Application (ANDA) to the FDA for NRX-100, its preservative-free intravenous ketamine formulation aimed at approved indications such as anesthesia and pain management. With the U.S. ketamine market valued at $750 million and global demand projected to reach $3.35 billion by 2034, the company is seeking priority review amid an ongoing national shortage. NRx also plans to petition the FDA to mandate preservative-free ketamine formulations, citing safety concerns over benzethonium chloride. This filing complements its broader strategy to expand ketamine’s label to include treatment for suicidal depression, backed by clinical data…

Continue Reading

ThursdayJun 05, 2025 10:00 am

BioMedNewsBreaks – Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI) Receives Italian Clearance for Option to Acquire Biotech Firm Pincell

Scinai Immunotherapeutics (NASDAQ: SCNI) announced it has received regulatory clearance under Italy’s Golden Power regulation to proceed with its option to acquire 100% of Pincell S.r.l., an Italian biotech company. The approval, issued by Italy’s Coordination Group and Ministry of Health, supports Scinai’s strategic move to expand its inflammation and immunology pipeline. Pincell’s lead asset, PC111—a monoclonal antibody targeting the Fas/FasL pathway—holds Orphan Drug Designation in Pemphigus and is being developed for severe skin disorders. The acquisition remains subject to final conditions, including a €12 million grant decision expected later this summer. To view the full press release, visit https://ibn.fm/4B2g5…

Continue Reading

ThursdayJun 05, 2025 9:50 am

BioMedNewsBreaks – CNS Pharmaceuticals Inc. (NASDAQ: CNSP) to Present Promising Glioblastoma Data at Brain Tumor Biotech Summit

CNS Pharmaceuticals (NASDAQ: CNSP) announced that Chief Medical Officer Sandra Silberman, M.D., Ph.D., will present at the Brain Tumor Biotech Summit hosted by Lenox Hill Hospital’s Department of Neurosurgery on June 5, 2025. Her presentation, titled "The Future and Promise of TPI 287," will highlight CNS’s brain-penetrating taxane candidate, which has shown efficacy in glioblastoma patients, including 3 complete and 9 partial responses in a Phase 1 trial. TPI 287, which has FDA Orphan Drug Designation for gliomas, pediatric neuroblastoma, and progressive supranuclear palsy, may offer a breakthrough in treating CNS tumors by effectively crossing the blood-brain barrier. To view…

Continue Reading

WednesdayJun 04, 2025 3:36 pm

BioMedNewsBreaks — Adageis Empowers Providers with Actionable Insights for Value-Based Care Success

Adageis, a growing healthcare technology company, offers a unique streamlined and AI-powered software solution designed to make the shift toward value-based care simpler for healthcare practices. “At the core of the company’s offering is the ProActive Care Platform, a patented, AI-centric engine that enables providers, health systems, ACOs, and CINs to identify and act on high-value opportunities within their existing operations,” reads a recent article. “What sets Adageis apart is ease of use, giving practices clear, actionable insights on where value lies, and how to pursue it while maintaining or improving quality of care.” To view the full article, visit…

Continue Reading

WednesdayJun 04, 2025 11:14 am

BioMedNewsBreaks — Soligenix Inc. (SNGX) Highlights HyBryte Progress in CTCL via New Podcast Featuring Dr. Ellen Kim 

Soligenix (SNGX) is spotlighting new interim data on HyBryte(TM) (synthetic hypericin) for early-stage cutaneous T-cell lymphoma (CTCL) in a recent podcast hosted by the Cutaneous Lymphoma Foundation. Featured guest Dr. Ellen Kim, Principal Investigator of the ongoing investigator-initiated study and Director of the Penn Cutaneous Lymphoma Program, reported a 75% treatment success rate at 18 weeks and up to 85% improvement in patients treated through 54 weeks. The study builds on prior results from the Phase 3 FLASH trial and mirrors the design of the current FLASH2 confirmatory trial, now enrolling patients. Dr. Kim emphasized HyBryte’s safety and tolerability, with…

Continue Reading

TuesdayJun 03, 2025 9:20 am

BioMedNewsBreaks – Nutriband Inc. (NASDAQ: NTRB) to Present at Noble Capital Markets Emerging Growth Virtual Conference

Nutriband (NASDAQ: NTRB) announced that CEO Gareth Sheridan will present at Noble Capital Markets’ Emerging Growth Virtual Equity Conference on Thursday, June 5 at 4 p.m. ET. The session will feature a fireside-style Q&A open to live audience questions, with 1x1 meetings available for qualified investors. A webcast of the presentation will be accessible post-event on Nutriband’s website and Channelchek.com, where it will remain archived for 90 days. To view the full article, visit https://ibn.fm/2U9UL About Nutriband Inc. Nutriband is primarily engaged in the development of a portfolio of transdermal pharmaceutical products. Its lead product under development is an abuse-deterrent…

Continue Reading

MondayJun 02, 2025 9:20 am

BioMedNewsBreaks – Nutriband Inc. (NASDAQ: NTRB) Posts Record Q1 Revenue, Advances AVERSA Fentanyl Development

Nutriband (NASDAQ: NTRB) reported first-quarter revenue of $667,000, a 63% year-over-year increase driven by expanded kinesiology tape production through its Pocono Pharma subsidiary and growing retail presence at Target, Walmart, Walgreens, and CVS. The company continues to prioritize shareholder value by scaling Pocono’s output through penetration pricing strategies while advancing development of AVERSA Fentanyl, an abuse-deterrent transdermal opioid patch. A newly formalized partnership with Kindeva Drug Delivery will support shared development costs in exchange for milestone payments as AVERSA moves toward regulatory approval. The product is projected to reach peak U.S. sales of $80 million to $200 million annually. To…

Continue Reading