Shares of Kura Oncology plunged in trading on November 24 after the San Diego-based company announced the U.S. Food and Drug Administration placed a partial clinical hold on a Phase Ib leukemia study assessing KO-539 following the report of a patient’s death.
A trial assessing an experimental AstraZeneca cancer drug was placed on clinical hold due to safety concerns. The trial pause comes two years after Amgen was also forced to pause a study of a drug within the same class.
The U.S. Food and Drug Administration placed a clinical hold on BioMarin Pharmaceutical’s BMN 307 Phearless Phase I/II study.
The U.S. Food and Drug Administration placed a clinical hold on Boston-based Aprea Therapeutics’ lymphoid malignancy trial after the regulatory agency expressed concerns regarding the safety and efficacy data from a previous myelodysplastic syndromes (MDS) study.
Shares of bluebird bio were down more than 24 percent after the company announced that the U.S. Food and Drug Administration placed a clinical hold on studies of the gene therapy elivaldogene autotemcel (eli-cel) for cerebral adrenoleukodystrophy (CALD).
Novartis will launch a new phase three study to expand the use of Zolgensma – the world’s most expensive one-time therapy at $2.1 million per patient treatment – after the U.S. regulator lifted its restrictions.
Regeneron Pharmaceuticals said on May 17 the company was resuming the enrollment of patients in two studies testing the experimental lymphoma drug odronextamab after the U.S. Food and Drug Administration agreed to lift a partial clinical hold.
The U.S. Food and Drug Administration placed a clinical hold on KalVista Pharmaceuticals’ proposed Phase II trial of KVD824, a prophylactic treatment of hereditary angioedema. The regulatory agency requested additional information and analysis of preclinical studies regarding KVD824 before giving the go-ahead to the Phase II trial.
The U.S. Food and Drug Administrationlifted a clinical hold on Audentes Therapeutics’ ASPIRO trial studying AT132 as a potential treatment for X-linked myotubular myopathy (XLMTM), a rare neuromuscular disease.
The U.S. Food and Drug Administration placed a clinical hold on patient enrollment and dosing in an early-stage trial of the Bellicum Pharmaceuticals’ cancer treatment BPX-601, after the death of a patient.