FDA
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…
Read More
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…
Read More
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…
Read More
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…
Read More
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…
Read More
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…
Read More
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…
Read More
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,…
Read More
A recent study found that Viz ANEURYSM had a 94 percent accuracy rate of diagnosing subarachnoid hemorrhages on computed tomography angiography (CTA). Excerpt from the Press Release: Subarachnoid hemorrhages reportedly affect nearly 30,000 Americans each year and have a 40 percent mortality rate. However, Viz ANEURYSM, a new artificial intelligence (AI)-powered algorithm, may improve the…
Read More
Excerpt from the Press Release: CARLSBAD, Calif.–(BUSINESS WIRE)–ChromaCode, Inc., a company redefining molecular testing through data science, announced today that the U.S. Food and Drug Administration has expanded the Emergency Use Authorization of ChromaCode’s HDPCR SARS-CoV-2 Assay to include several new qPCR instruments and use of 384-well plates, which has the potential to more than…
Read More