LONDON – Redx Pharma plc is in the process of handing its RXC-006 program over to Astrazeneca plc, after signing a potential $377 million development and commercialization deal for the porcupine inhibitor in the treatment of fibrotic disease.
PERTH, Australia – Melbourne-based Dimerix Ltd.’s stock shot up nearly 20% on the news that its lead compound, DMX-200, met primary and secondary endpoints in a phase IIa trial in patients with rare kidney disease focal segmental glomerulosclerosis (FSGS), according to top-line results.
With an Aug. 22 PDUFA date set, Tricida Inc. said it received an FDA notification regarding the NDA for veverimer (TRC-101) for treating metabolic acidosis in chronic kidney disease (CKD) patients, noting that it had identified deficiencies precluding discussion of labeling and postmarketing requirements/commitments.
While members of the FDA’s Cardiovascular and Renal Drugs Advisory Committee all recognized the severity of hepatorenal syndrome type 1 (HRS-1) and the significant unmet need in the space, they were divided on whether the FDA should follow the decades-old lead of regulators in 60 other countries in approving Mallinckrodt plc’s terlipressin as an HRS-1 treatment.
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.
As the company gears up for two NDA filings this year, Reata Pharmaceuticals Inc.’s $350 million deal with funds managed by Blackstone Life Sciences provides cash runway through the end of 2023.
In a bid to expand its presence in the cardiometabolic disease space and strengthen its core business in diabetes and obesity, Novo Nordisk A/S is buying Corvidia Therapeutics Inc., of Waltham, Mass., for $2.1 billion, which includes a $725 million up-front payment.
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.
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