FDA
Excerpt from the Press Release: SAN DIEGO–(BUSINESS WIRE)–Pipeline Therapeutics, a clinical-stage biopharmaceutical company pioneering precision neuroregeneration, today reported positive clinical data from its recently completed Phase 1 clinical trial evaluating the safety and tolerability of PIPE-307 in healthy volunteers. PIPE-307, the company’s lead program for myelin restoration, is an oral, highly selective antagonist of the…
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NTLA-5001, a novel T cell receptor (TCR)-T cell therapy, is currently being evaluated in a Phase 1/2a study in adults with persistent or recurrent acute myeloid leukemia Excerpt from the Press Release: CAMBRIDGE, Mass., March 09, 2022 (GLOBE NEWSWIRE) — Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading clinical-stage genome editing company focused on developing potentially curative…
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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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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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Excerpt from the Press Release: MARTINEZ, Calif.–(BUSINESS WIRE)–Investigators today announced the first patient enrollment in the Blood Purification for the Treatment of Pathogen Associated Shock (PURIFY-RCT) trial. PURIFY-RCT is a prospective interventional multicenter randomized controlled trial, sponsored by the Department of Defense in collaboration with the Henry M. Jackson Foundation and the Uniformed Services University of Health…
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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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Dragonfly receives a milestone payment from Bristol Myers Squibb for progression of its Phase 1 DF6002-001 study with a PK profile and peripheral PD consistent with preclinical models Excerpt from the Press Release: WALTHAM, Mass., March 1, 2022 /PRNewswire/ — Dragonfly Therapeutics, Inc. (“Dragonfly”) today announced the achievement of a Phase 1 clinical development milestone for the…
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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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Excerpt from the Press Release: REDWOOD CITY, CA / ACCESSWIRE / February 28, 2022 / Avinger, Inc. (NASDAQ:AVGR), a commercial-stage medical device company marketing the first and only intravascular image-guided, catheter-based system for diagnosis and treatment of Peripheral Artery Disease (PAD), today announced that physicians in the U.S. have successfully completed first cases with its new…
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CMS establishes new Level II HCPCS code for Prescription Digital Behavioral Therapy, FDA Cleared, per Course of Treatment to describe prescription digital therapeutics (PDTs) including Pear’s PDTs for the treatment of substance use disorder (reSET®), opioid use disorder (reSET-O®), and chronic insomnia (Somryst®), respectively The new code marks an important access and reimbursement milestone for providers, payers,…
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