LONDON – Clinical care guidelines recommending the use of the HIV/AIDS combination lopinavir-ritonavir for the treatment of patients hospitalized with COVID-19 must now be updated, say the authors of a paper reporting the full results of a randomized U.K. study showing the antiviral is not effective in this context, published in The Lancet on Oct. 5.
Synthetic Biologics Inc. said a phase IIb trial of one of its two lead candidates, SYN-010, in people with constipation-predominant irritable bowel syndrome (IBS-C) will be discontinued after an interim futility analysis suggested it was unlikely to meet the study's primary endpoint.
Pharmacyte Biotech Inc. is now in a series of 30-day cycles with the FDA as a planned phase IIb study of its lead candidate has been placed on hold. On Sept. 2, Pharmacyte submitted its IND for a phase IIb trial of its product, known as Cypcap, in locally advanced, inoperable pancreatic cancer and, on Oct. 2, the company said the FDA placed the application on hold.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aiviva, Algernon, Astrazeneca, Cytokinetics, Epygenix, Kyowa, Mei, Otonomy, RVL, Synthetic Biologics, Xencor.
With phase III vaccine trials nearly enrolled and data expected soon, a half-year of expedited development efforts, plus massive government funding may soon provide the ammunition needed to effectively stop the SARS-CoV-2 scourge of 2020.
FDA enforcement of clinical research regulations has often been "light-handed, slow-moving, and secretive," a new look at the agency's enforcement track record concludes. Published today in the journal Science, the analysis said the shortcomings may be harming both patients and trial integrity.
As his firm unveiled early data with its spike protein-targeting COVID-19 therapy, Regeneron Pharmaceuticals Inc.’s chief scientific officer, George Yancopoulos, said that, even if researchers come up with a drug that works, coming up with efficient point-of-care diagnostics remains “a major societal imperative.”
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