HONG KONG – Astellas Pharma Inc. reported positive results from phase III of its DOLOMITES study comparing the efficacy and safety of roxadustat to that of darbepoetin alfa in treating anemia in nondialysis-dependent, stage 3 to 5 chronic kidney disease (CKD) patients.
Fidget spinners are hand-held toys based on a roller bearing and three weighted lobes, which can spin freely, creating centrifugal force when activated manually.
Aduro Biotech Inc. and privately held Chinook Therapeutics Inc., will merge to focus mainly on kidney diseases. Two complementary drugs are involved in the deal.
Fidget spinners are hand-held toys based on a roller bearing and three weighted lobes, which can spin freely, creating centrifugal force when activated manually. Generating centrifugal force with a fidget spinner takes neither electricity nor trained staff. And that has suggested to several researchers that such spinners, under the right circumstances, could be used for centrifugation under circumstances where reliably operating a centrifuge, for whatever reason, is a challenge.
Nearly four years after differences between U.S. and Russian clinical results derailed an NDA for its pregnancy prevention candidate, Phexxi, San Diego-based Evofem Biosciences Inc. has prevailed, winning FDA approval today for the vaginal pH regulator.
Marking a key advance for Akebia Therapeutics Inc. in the global race to establish a new class of medicines for chronic kidney disease-associated anemia, the first of its two pivotal phase III programs proved its lead candidate, vadadustat, noninferior to darbepoetin alfa in adults on dialysis.
Despite the higher placebo response than a previous, identically designed experiment turned up, Cara Therapeutics Inc.’s Kalm-2 phase III study Korsuva (CR-845/difelikefalin) for injection handily reached its primary endpoint in hemodialysis patients with moderate to severe chronic kidney disease-associated pruritus (CKD-aP).
LONDON – AM-Pharma BV raised a further $52 million for the phase III trial of its recombinant alkaline phosphatase product, Recap, in treating sepsis-associated acute kidney injury (AKI), but now faces a delay in starting the study, as the COVID-19 crisis takes up more and more clinical resources.
Now that Rockwell Medical Inc.’s intravenous formulation of Triferic, Triferic AVNU (ferric pyrophosphate citrate) is FDA-approved, the nod coming a day before its PDUFA date of March 28, the company plans putting evaluation programs into action during the third quarter of this year. Only after those programs’ completion will the formulation be available commercially.
Geneva-based Obseva SA’s phase III Primrose 2 trial with gonadotropin-releasing hormone (GnRH) antagonist linzagolix in heavy menstrual bleeding (HMB) due to uterine fibroids (UFs) hit the primary endpoint in 94% of patients, and the company in the second quarter of 2020 will report six-month data from the Primrose 1 study, which is also a phase III experiment, in the same indication.
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