Drug Safety

Latest Headlines

Latest Headlines

French investigators to Biotrial: You should have stopped fatal study earlier

French Health Minister Marisol Touraine has criticized the CRO behind a botched drug trial that has seen one die and 5 others seriously ill for failing to stop the study.

French authorities still don't know what happened in fatal drug trial

French health regulators have yet to determine exactly went wrong in a drug trial that left one volunteer dead last month, working to establish the cause of a Phase I disaster that has shaken up the drug industry.

Big Pharma chalks up victory in Arizona Supreme Court over Rx safety warnings

Big Pharma can celebrate a bright point. Arizona's top court ruled that drugmakers don't have an obligation to warn patients directly about safety risks of their meds. Raising those warnings with doctors is enough, the court determined.

French CRO Biotrial tries to move forward after disastrous clinical study

Biotrial, the CRO that ran a Phase I study that proved deadly, said it's working with authorities to piece together what went wrong while trying to move its business forward.

FDA says microbial contamination found at Montana Compounding

Being able to take your dogs to the office may be a perk at some workplaces, but the FDA doesn't think it is such a great idea for a compounding pharmacy. So says an FDA warning letter posted this week for a compounder, another action in the FDA's effort to bring up the standards of that industry.

J&J halts a depression program in the shadow of a fatal French trial

In the wake of a disastrous French clinical trial that left one volunteer dead, Johnson & Johnson has voluntarily suspended development of a similar drug until more information comes to light.

Crippled by 2 deaths, Zafgen says obesity drug cut weight in PhIII

With its clinical development program for a new obesity drug in limbo following the unexplained deaths of two patients, Zafgen reported today that the troubled Phase III study hit its co-primary efficacy endpoints in treating a rare eating disorder.

Roche blindsided by off-label Avastin fallout in India

Roche, maker of pricey wet age-related macular degeneration drug Lucentis, has long railed against countries' moves to use its cancer drug Avastin off-label for the same condition, arguing that there isn't any real proof that the med can safely treat the blinding eye disease. Now the company has new ammo to bolster its argument, as two states in India suspended sales of Avastin after it caused vision problems in patients.

Supreme Court rebuffs another J&J appeal, leaving $140M failure-to-warn judgment intact

Johnson & Johnson is zero for two at the U.S. Supreme Court this month. Last week, the court refused to weigh its final appeal against a $124 million penalty in a Risperdal marketing case. Now, the high court has said the same about an even bigger judgment.

French drug trial disaster leaves patient dead amid a slew of unanswered questions

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.