The patient left brain-dead in last week's botched drug trial has died, French authorities said, spurring more questions about how a routine Phase I study went awry and sent 6 volunteers to the hospital.
The congressional watchdog has taken the FDA to task over the IT system it uses to track the safety of approved drugs. Officials at the Government Accountability Office told the FDA it should identify IT investments that will enable regulatory staffers to "easily and systematically" access postmarket data for oversight purposes.
A botched Phase I trial has left 6 patients in serious condition with one effectively "brain-dead," according to the French government, which has opened an investigation.
Researchers at the University of California in Santa Barbara have formulated drugs as liquid salts to enable delivery through the skin without the toxicity associated with organic solvents.
Earlier this year, U.S. regulators updated the label of Novartis' multiple sclerosis pill, Gilenya, to reflect cases of serious brain infections linked to the treatment. And now, its counterparts across the pond are following suit.
Recent reports have shown that Gilead's hep C superstars are linked to fewer serious side effects than AbbVie's rival med Viekira Pak. But Harvoni could take home the prize of being the safest option of the three drugs, as it turned up fewer serious side effects in postmarketing safety data than its hep C peers.
Catalent's production interruption at a French plant because of suspected product tampering is being felt by clients. GlaxoSmithKline has had to delay the launch of a hair loss drug in Japan while it figures out another location that can produce it.
The New England Journal of Medicine has laid out the data from a cardiovascular outcomes trial of Sanofi's GLP-1 diabetes hopeful Lyxumia, and the good news for the French drugmaker is that the drug didn't raise the rate of major cardiovascular events in patients with acute coronary syndrome. But it didn't lower it, either.
Six weeks after Zafgen finally broke an uncomfortable silence and acknowledged that a patient taking its experimental obesity drug beloranib had died, the company is reporting that a second patient has died--this time from bilateral pulmonary emboli.
William Scully, one of two owners of Medical Device King based in New York, was convicted on charges that he sold more than $17 million worth of fake or unapproved drugs that were manufactured overseas.