With full approval from the U.S. FDA in hand for Travere Therapeutics Inc.’s Filspari (sparsentan) to slow kidney function decline in adults with primary IgA nephropathy (IgAN) who are at risk of disease progression, eyes turned to future prospects as well as how a revised risk evaluation and mitigation strategies (REMS) program might shake out. During a conference call hosted by Travere, Leerink analyst Joseph Schwartz wanted to know what changes might be made, and if the regulator’s decision might “actually be an entire removal” of the REMS.
The FDA reported several class I recalls in the first week of September 2024, a list that includes products such as Medtronic plc’s McGrath line of laryngoscopes, some of which should be jettisoned.
Medigene AG has obtained FDA clearance of its IND application for lead program MDG-1015 for the treatment of advanced gastric cancer, ovarian cancer, myxoid/round cell liposarcoma and synovial sarcoma.
Abdera Therapeutics Inc.’s ABD-147 has been granted U.S. orphan drug designation for the treatment of neuroendocrine carcinoma. ABD-147 is a next-generation precision radiopharmaceutical biologic therapy designed to deliver actinium-225 (225Ac) to solid tumors expressing DLL3.
After receiving a complete response letter from the U.S. FDA more than three years ago and conducting another phase III trial, Iterum Therapeutics plc is preparing to make its case before an advisory committee Sept. 9 for sulopenem etzadroxil/probenecid as an oral treatment option for women with uncomplicated urinary tract infections caused by specific microorganisms.
With Novo Nordisk A/S hobbled by a complete response letter, Eli Lilly and Co. has forged ahead in developing a once-weekly type 2 diabetes treatment. Top-line data from Lilly’s phase III Qwint-1 and Qwint-3 studies of efsitora alfa showed noninferior average levels of blood glucose, A1C, compared to those using another daily basal insulin treatment.
Adaptin Bio has obtained IND clearance from the FDA for APTN-101 in glioblastoma, enabling initiation of a first-in-human phase I trial in patients diagnosed with WHO grade IV malignant glioma.
Following a bioresearch monitoring inspection, the U.S. FDA slapped Julio Flamini, a clinical investigator at the Research Center of Atlanta, with a warning letter citing a “significant” protocol violation in which a 15-year-old girl was given 10 times the maximum daily dose of an unnamed study drug for a week.
Litigation between companies in the med-tech space often revolves around patents, but the ongoing series of lawsuits between Philips Respironics Inc. and Soclean Inc. are directed toward the interaction between CPAP machines and CPAP cleaning systems.
The U.S. FDA is accused of dragging its feet on making public the devices for which it granted market access under the de novo program, and the agency recently been scrambling to bring these decision summaries to light.
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