Tag Archives: raises

FDA staff raises safety concerns over Trevena opioid drug

(Reuters) – Staff reviewers of the U.S. Food and Drug Administration on Tuesday raised safety concerns over Trevena Inc’s opioid injection to treat acute pain, saying the treatment has an abuse and overdose potential. The treatment, oliceridine, aims to manage moderate-to-severe acute pain in adult patients for whom an intravenous opioid is warranted. FDA staff… Read More »

Rare manufacturing glitch raises concern over CAR-T therapies: study

CHICAGO (Reuters) – A single leukemia cell inadvertently got mixed in with a batch of a patient’s immune cells that were being manufactured into a CAR-T cell therapy and it acquired resistance to the treatment with deadly results, University of Pennsylvania researchers reported on Monday. The mishap occurred in a 20-year-old leukemia patient treated with… Read More »