The FDA’s Center for Drug Evaluation and Research (CDER) came out punching Oct. 17 at the start of a three-day hearing before the Obstetrics, Reproductive and Urologic Drugs Advisory Committee on whether Covis Pharma BV’s Makena (17-hydroxyprogesterone caproate), a branded version of a drug that’s been used since 1956 to prevent preterm births, should be withdrawn from the market.
Primary ovarian insufficiency (POI) is a clinical syndrome characterized by premature exhaustion of the resting pool of primordial follicles before the age of 40 years in women; the mechanism of follicular depletion is not well understood.
In its case to a U.S. FDA advisory committee, the Center for Drug Evaluation and Research makes no bones about its dislike of Makena, (17-hydroxyprogesterone caproate), a drug for preventing miscarriages. It simply doesn’t work, the group maintains.
After two years of talks, privately held Ventus Therapeutics Inc. and Novo Nordisk A/S have signed an exclusive worldwide license deal to commercialize candidates from Ventus’ portfolio of peripherally restricted NLR pyrin domain-containing 3 (NLRP3) inhibitors. Along with Roche Holding AG’s September 2020 acquisition of Inflazome Ltd. and Novartis AG’s buyout of subsidiary IFM Tre in April 2019, this is another step by big players to get into the NLRP3 space.
With four complete response letters behind it and seven months ahead of its April 2023 PDUFA date, Mallinckrodt plc’s Terlivaz (terlipressin) has been approved by the U.S. FDA for treating hepatorenal syndrome. Terlivaz had a decade-long series of obstacles before getting the long-awaited approval. The vasopressin analogue selective for V1 receptors was approved, in part, on results from the phase III CONFIRM trial of 300 patients, which met its primary endpoint of renal function improvement, avoidance of dialysis and short-term survival (p=0.012).
After a midstage trial showed no benefit from adding ELX-02 (exaluren) to Kalydeco (ivacaftor, Vertex Pharmaceuticals Inc.) for certain cystic fibrosis (CF) patients, Eloxx Pharmaceuticals Inc. said it will discuss next steps for the program, its lead candidate, with the trial's sponsor, the CF Foundation. A proof-of-concept trial for EXL-02 in the rare kidney disease Alport syndrome will start later this year, the company said.
Melbourne-based Occurx Pty Ltd. announced a AU$16 million (US$11 million) series B round that will progress lead candidate OCX-063 to phase II trials in chronic kidney disease. The capital raise was jointly led by Brandon Biocatalyst and Uniseed and includes a AU$1.5 million grant from Australian biomedical incubator Cureator.
Women now have a new treatment option for dealing with the pain associated with endometriosis with U.S. FDA approval of Myfembree (relugolix/estradiol/norethindrone acetate) for managing moderate to severe pain associated with endometriosis in premenopausal women.
Women now have a new treatment option for dealing with the pain associated with endometriosis with U.S. FDA approval of Myfembree (relugolix/estradiol/norethindrone acetate) for managing moderate to severe pain associated with endometriosis in premenopausal women.
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