As the world awaits more phase III data due any day from Akebia Therapeutics Inc. with vadadustat, its oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), in chronic kidney disease (CKD), the company is basking in the approval of the product in Japan as Vafseo as a once-daily treatment for CKD anemia.
Detailed results from a phase III test of Astrazeneca plc's Farxiga found that adding the drug to standard of care in patients with chronic kidney disease reduced a composite measure of worsening of renal function or risk of cardiovascular or renal death by 39% compared to placebo.
Med-tech IPOs continue to make it out onto a strong stock market, even as global economic uncertainty prevails amidst the unfolding pandemic. Single-cell biology research company Berkeley Lights Inc. priced an upsized IPO to raise $178.2 million to back its tools that are used to help develop antibody therapeutics, cell therapies and, more broadly, synthetic biology products.
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.
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.
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.
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.
New top-line results from a phase III study of Ardelyx Inc.'s tenapanor – recently approved in irritable bowel syndrome – confirmed the drug can also help dialysis-dependent chronic kidney disease patients with hyperphosphatemia achieve reduced serum phosphorus levels vs. placebo.
Proteon Therapeutics Inc.'s inventorying of options after the phase III failure with vonapanitase in chronic kidney disease (CKD) ended in a merger deal with Artara Therapeutics Inc., a startup that has hung its main hat on TARA-002, a therapy for lymphatic malformations (also called lymphangiomas) that has already gained validation by way of a similar product in Japan.
