CAJICA, Colombia – Cuba’s Center for the State Control of Drugs, Equipment and Medical Devices gave the green light March 3 for phase III trials of a domestically developed COVID-19 vaccine candidate, even though very little peer-reviewed information has been published about it.
San Diego-based Neurocrine Biosciences Inc.’s good-and-bad top-line phase II data with d-amino acid oxidase inhibitor luvadaxistat, also known NBI-1065844 and TAK-831, in schizophrenia likely came as little surprise to many, given earlier experience in the general pathway.
Liver disease specialist Ascletis Pharma Inc. said its nonalcoholic steatohepatitis (NASH)-focused subsidiary, Gannex Pharma Co. Ltd., will start global development of its oral THR-β agonist, ASC-41, after it obtained an IND approval from the FDA based on positive phase I data generated in China.
A failure of Tricida Inc.'s most recent efforts to overcome FDA objections to an NDA for the company's sole candidate, veverimer, for treating metabolic acidosis, sent company shares (NASDAQ:TCDA) 30.6% lower to $5.11 on Feb. 26. The complex story appears focused now on the agency's desire for additional and more reliable data to support a potential approval. Tricida President and CEO Gerrit Klaerner on Thursday suggested the ongoing renal outcomes study, Valor-CKD, might provide it.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Amgen, Arbutus, Assembly, Astrazeneca, Innovation, Partner, Pharvaris, Revive, XNK.
Drug and device companies dragging their feet on diversifying late-stage clinical trials could conceivably get a wake-up call in court or in FDA approval delays. A final guidance the FDA released in November suggests that the days of ignoring segments of the intended treatment population until safety signals flare in real-world use are coming to an end.
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