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.

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.

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Adial, Aimmune, Aivita, Altimmune, Bioage, Biontech, Bioxcel, Bluebird, BMS, Celsion, Chimerix, Clene, CNS, Compugen, EMD Serono, Entera, I-Mab, GSK, Karuna, Kronos, Pfizer, Regeneron, Roche, Springworks, Stero, Viela.

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Akero, Click, Constant, Gtreebnt, Locus, Longeveron, Marinomed, Nanoform, Neurorx, Novavax, Opthea, Otsuka, Regentree, Salarius, Takeda, Theralase, Theravance.

Pfizer Inc. and Biontech SE submitted new data to the FDA showing its COVID-19 vaccine’s stability can be maintained at temperatures often found in pharmaceutical freezers and refrigerators: -13°F to 5°F (-25°C to -15°C).

Astrazeneca plc officials, during the firm’s Feb. 11 conference call on fourth-quarter earnings, highlighted the oral selective estrogen receptor degrader (SERD) camizestrant in breast cancer (BC), which Cristian Massacesi, head of late-stage oncology development, said bears “best-in-class potential, in terms of providing superior clinical benefit at a well-tolerated dose” of 75 mg once per day.