Press Releases
– Molecular Intelligence Trials (MI Trials) collaboration will enhance identification of patients with NTRK fusion-positive solid tumors, including primary and metastatic CNS tumors potentially eligible for enrollment in the ongoing PBI-200-101 Phase 1/2 clinical study – Pyramid Biosciences currently developing pipeline of clinical-stage precision medicines, including its lead program PBI-200, a next-generation, highly CNS penetrant…
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Cefepime-taniborbactam met the primary noninferiority efficacy endpoint anddemonstrated statistical superiority to meropenem Cefepime-taniborbactam was well-tolerated with similar safety profile to meropenem NDA on track to be submitted in the fourth quarter 2022 Excerpt from the Press Release: Malvern, PA, March 10, 2022 – Venatorx Pharmaceuticals today announced positive results from its pivotal Phase 3 study evaluating cefepime-taniborbactam, an…
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First-in-class lysine gingipain inhibitor, atuzaginstat, has the potential to reduce the malignant progression of oral potentially malignant disorders (OPMD) In vitro study results demonstrate that PD-L1 is induced by P. gingivalis and can be blocked by atuzaginstat Atuzaginstat ready to begin a Phase 2 trial for expansion into high-risk OPMD indication; IND submission expected in…
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Helsinn Group and BridgeBio Pharma Announce Update to Strategic Collaboration to Develop, Manufacture and Commercialize Infigratinib in Oncology Indications in the U.S. Helsinn gains an exclusive license to commercialize infigratinib in the U.S. Excerpt from the Press Release: Lugano, Switzerland and Palo Alto, CA, March 3, 2022 – Helsinn Group (Helsinn), a fully integrated, global…
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FDA granted IND clearance today for STI-9199 (COVISHIELD™) for a Phase 1 safety and pharmacokinetic study in healthy volunteers. Initial trials are expected to be followed by a multinational Phase 2/3 trial in both mild and moderate COVID-19 patients. STI-9199 has demonstrated in vitro and in vivo activity against all SARS-CoV-2 variants tested, including the…
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Transgenic mouse model reflects latest scientific understanding of disease – toxic oligomers of amyloid create cognitive deficit Excerpt from the Press Release: ORONTO, Ontario and CAMBRIDGE, Mass., March 02, 2022 (GLOBE NEWSWIRE) — ProMIS Neurosciences, Inc. (TSX: PMN) (OTCQB: ARFXF), a biotechnology company focused on the discovery and development of antibody therapeutics targeting misfolded proteins such as…
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Intra-Articular Injection Strategy Shows Efficacy Across Multiple Clinical Endpoints and Favorable Safety Profile After 12 Weeks of Therapy Data From the Phase 2 Study Support the Potential of AMB-05X as a Best-in-Class Therapy for Treatment of TGCT Excerpt from the Press Release: REDWOOD CITY, Calif., March 02, 2022 (GLOBE NEWSWIRE) — AmMax Bio, Inc. (“AmMax”),…
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Business Associate Agreement and Clinical Trial Agreement with Additional Planned Studies and Commercial and Scientific Collaboration Excerpt from the Press Release: SANTA CLARA, Calif.–(BUSINESS WIRE)–HeartBeam, Inc. (NASDAQ: BEAT), a developmental stage digital healthcare company with a proprietary ECG telemedicine technology for heart attack detection, today announced it has signed a Business Associate Agreement (BAA) and Clinical…
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Dexcom CGM to be evaluated for performance in the hospital and for the potential of more effective glycemic management and improved patient outcomes in the hospital setting Breakthrough Device Designation from the FDA is a critical milestone for in-patient Dexcom CGM use This designation provides a more efficient and streamlined review pathway so innovative Dexcom…
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Following Discussion with the FDA, Karyopharm Plans to Initiate a New Placebo-Controlled Randomized Study of Selinexor in the Advanced or Recurrent Endometrial Cancer p53 Wild-Type Population to Support a Future sNDA Submission as the Current Topline Data from the SIENDO Study are Unlikely to Support an sNDA Approval Karyopharm is Encouraged by the SIENDO p53…
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