The U.S. FDA placed a partial hold on Berkeley, Calif.-based Aduro Biotech’s LADD trials.
Regeneron and partner Teva said the U.S. health regulator placed a clinical hold on a mid-stage study of their experimental drug for chronic lower back pain.
GenVec was notified by its collaborator Novartis that FDA has lifted the clinical hold on the Phase 1/2 clinical trial of CGF166 in patients with severe to profound hearing loss.
Zafgen Inc said the U.S. Food and Drug Administration was putting a late-stage study testing its experimental obesity drug on complete hold after a second patient died during the trial. The company’s shares fell 7.4 percent to $5.81 in extended trading after closing down 60 percent on Wednesday. A complete clinical hold is an order […]
A second patient died in a late-stage trial of Zafgen Inc’s experimental obesity treatment, highlighting safety concerns associated with drugs that aim to treat a condition that affects one in three Americans. Shares of Zafgen tumbled more than 50 percent to $8.00 in premarket trading on Wednesday. The company said a patient receiving its drug, […]
Zafgen Inc said the U.S. Food and Drug Administration had put a late-stage trial of its obesity drug on partial hold, two days after the drug developer reported the death of a patient during the study. Zafgen’s stock was down about 24 percent at $15.92 in light premarket trading. Zafgen said it still expects to […]
AstraZeneca has temporarily halted two clinical trials combining experimental drugs to treat lung cancer, following reports of lung disease in some patients, the company said on Friday. The trials involve giving its drug AZD9291, which is currently awaiting regulatory approval, alongside the immune system-boosting medicine durvalumab, also known as MEDI4736, to treat patients with advanced […]
Advaxis Inc said the U.S. Food and Drug Administration has put on hold the mid-stage trials of its experimental cancer drug after a patient died, sending its shares down 27 percent in extended trading yesterday. The clinical hold on the drug, axalimogene filolisbac, was issued after Advaxis submitted a safety report to the FDA, the […]