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.”
With a Dec. 20 PDUFA date bearing down on relugolix from Myovant Sciences GmbH, of Basel, Switzerland, freshly released and slightly downbeat secondary endpoint phase III data created a rift with management and analysts on one side and investors on the other.
Ironwood Pharmaceuticals Inc. CEO Mark Mallon said the company will seek to grow Linzess (linaclotide) and “continue to scan the environment” for more prospects in gastrointestinal conditions after the phase III fizzle in one of two identical experiments with IW-3718 in refractory gastroesophageal reflux disease.
The always-busy American Society of Hematology meeting in December promises to include some especially intriguing datasets from the bispecific antibody space, as multiple players are likely to unveil findings related to their CD20xCD3 prospects.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Apeiron, Beyondspring, BMS, Genfit, Hansa, Marinus, Menarini, Novavax, Radius Rhizen, Uniqure.
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