Krystal Biotech Inc. has received FDA acceptance of its IND application for lead oncology drug candidate KB-707 for the treatment of locally advanced or metastatic solid tumor malignancies. KB-707 is a modified herpes simplex virus 1 (HSV-1) vector designed to deliver genes encoding both human IL-12 and IL-2 to the tumor microenvironment and promote systemic immune-mediated tumor clearance.
Cessation Therapeutics Inc. has obtained IND clearance from the FDA to initiate a first-in-human trial of CSX-1004 for the prevention of fentanyl overdose. The trial in healthy volunteers is expected to begin next month.
Nearly five years after submitting its first NDA seeking U.S. approval for Vanflyta (quizartinib) for treating a subset of patients with acute myeloid leukemia (AML), Daiichi Sankyo Co. Ltd. finally cleared the last hurdle. The FDA on July 20 approved the FLT3 inhibitor for use in combination with cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed disease that is FLT3 ITD-positive.
Epibone Inc. has received IND clearance from the FDA to begin testing its engineered allogenic osteochondral graft in humans. Clinical trials are set to open patient recruitment as soon as early next year.
A more than three-year commercial hold built up an estimated $1 billion in demand for Becton, Dickinson and Co.’s (BD) Alaris infusion system and BD has every intention of meeting that demand as quickly as possible now that it has FDA clearance for the updated device. The clearance allows the company to resume commercial sales and undertake remediation of its installed base of point-of-care units with enhanced features for its pumps and monitoring systems as well as new software and upgraded cybersecurity and interoperability.
Nearly five years after submitting its first NDA seeking U.S. approval for Vanflyta (quizartinib) for treating a subset of patients with acute myeloid leukemia (AML), Daiichi Sankyo Co. Ltd. finally cleared the last hurdle. The FDA on July 20 approved the FLT3 inhibitor for use in combination with cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed disease that is FLT3 ITD-positive.
Summer is the time when device makers press their cases for add-on and pass-through payments from the Medicare program, and this year’s draft hospital outpatient prospective payment system for calendar year 2024 is no exception. Both Cook Medical and Philips North America are pushing CMS for new technology pass-through (NTPT) payments for their offerings, but these two larger firms have a lot of company in the NTPT sweepstakes.
U.S. FDA warning letters to device makers seemed to be on pause for a couple of years, but the agency is picking up the pace with two warnings posted July 18. Outset Medical Inc., of San Jose, Calif., was previously known to be the recipient of a warning letter, but Edge Biologicals Inc. of Memphis, Tenn., took in a warning letter that is replete with repeat violations disclosed in 2015 and 2018, as well as a warning letter issued 11 years ago.
In a pivotal milestone for Memed Ltd., the U.S. FDA cleared its Memed BV test on whole blood samples, which will help health care providers distinguish between bacterial and viral infections. The test, which yields results in as little as 15 minutes, can reduce the risk of unnecessary prescriptions which is a key driver of antibiotic resistance.
GC Biopharma Corp., formerly Green Cross Corp., said July 17 that it refiled the BLA for its intravenous immune globulin agent Alyglo (GC-5107B; IVIG-SN 10%) to the U.S. FDA – nearly a year and a half after the regulator’s initial rejection.
RSS
