Breaks Categories: News

WednesdayJun 11, 2025 9:20 am

BioMedNewsBreaks – Intelligent Bio Solutions Inc. (NASDAQ: INBS) Expands U.S. Forensic Market Presence Through SMARTOX Partnership

Intelligent Bio Solutions (NASDAQ: INBS) reported continued growth in the U.S. Forensic Use Only Market through its strategic alliance with SMARTOX, a Texas-based leader in drug and alcohol screening services. SMARTOX has deployed over 50 INBS Intelligent Fingerprinting Drug Screening Readers and conducted more than 7,000 tests to date—including over 1,500 in 2024—demonstrating rising demand for INBS' rapid, non-invasive testing solution. The technology offers a fingerprint sweat-based alternative to urine and saliva tests, improving efficiency, dignity, and ease of use across corrections, rehabilitation, and drug court environments. INBS is also pursuing FDA clearance for its codeine opiate test, with plans…

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MondayJun 09, 2025 1:32 pm

BioMedNewsBreaks — Panna Sharma, Lantern Pharma CEO, Says FDA’s Elsa AI Rollout Underscores Urgency to Modernize

Panna Sharma, CEO of Lantern Pharma, commented on the U.S. Food and Drug Administration’s launch of its new AI tool in PharmaVoice, stating: “The timeline is aggressive, especially given that the scope and rigor of the initial pilot testing wasn’t fully showcased, but this reflects the urgency FDA feels.” His remarks highlight the rapid pace at which the agency is moving to integrate artificial intelligence into its regulatory infrastructure. The FDA officially announced the agency-wide deployment of Elsa, a generative AI tool designed to assist staff in reviewing clinical protocols, summarizing adverse events, comparing drug labels, and identifying inspection targets.…

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MondayJun 09, 2025 9:00 am

BioMedNewsBreaks – Nutriband Inc. (NASDAQ: NTRB) Secures U.S. Patent for Abuse-Deterrent Transdermal Technology

Nutriband (NASDAQ: NTRB) has been granted U.S. patent No. 12,318,492 for its "Abuse and Misuse Deterrent Transdermal Systems," further strengthening domestic protection for its Aversa(TM) technology. The patent, issued June 3, 2025, enhances the company’s intellectual property portfolio for abuse-deterrent transdermal products designed to curb misuse, diversion, and accidental exposure. Aversa(TM) is currently in development as part of Nutriband’s lead product, Aversa Fentanyl, which aims to be the first abuse-deterrent fentanyl patch on the market, with peak U.S. sales potential projected between $80 million and $200 million. To view the full article, visit https://ibn.fm/9bBiW About Nutriband Inc. Nutriband is primarily…

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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…

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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…

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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…

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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…

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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…

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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…

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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…

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