FDA starts pilot to help sponsors use novel trial designs | Digital Science
The FDA has initiated a pilot program (PDF) to help drug developers use complex innovative trial designs (CID). Sponsors accepted into the four-year pilot will…
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Trial
Xenon’s epilepsy drug clears phase 1b, setting stage for trial in patients…
A phase 1b trial has linked Xenon’s epilepsy candidate XEN1101 to statistically significant declines in measures of corticospinal and cortical excitability.…
Manafort juror says one holdout prevented conviction on all counts in…
Digital Asia News Update
caption Paula Duncan, one of the jurors from Paul Manafort’s trial. source Fox News A juror who participated in the trial of…
Sensei brings on new CMO as it eyes phase 2 immuno-oncology trial | Digital…
Sensei Biotherapeutics named Ildiko Csiki, M.D., Ph.D., as its new chief medical officer. Csiki was previously VP of immuno-oncology clinical development at…
Sirnaomics cleared to start first trial of RNAi lead in cancer | Digital…
Gene-silencing specialist Sirnaomics has been cleared to start trials of its STP705 drug in bile duct cancer, its first oncology indication. The FDA has…
Ukraine Electoral Commission Uses NEM Blockchain for Voting Trial |…
A member of Ukraine’s Electoral Commission revealed in an Aug. 7 Facebook post that they are working with NEM on a blockchain voting pilot. Oleksandr Stelmakh,…
U.K. commits to adopt EU trial regulation, minimize divergence after Brexit…
The U.K. regulatory agency has detailed how it expects Brexit to affect its clinical trial regulations. Officials reiterated their intent for the U.K. to…