The FDA approved a powerful new painkiller from Zogenix despite opposition from its own advisory panel. Now, attorneys general from 28 states have jumped in to ask the agency to reconsider.
It's well-documented that antibiotic resistance is a growing public health threat. Drug-resistant bacteria infect about 2 million Americans a year, causing at least 23,000 deaths, according to CDC data. Now, to keep resistance from mounting, the FDA is rolling out a plan to cut down on antibiotics use in livestock, enlisting the drugs' producers--companies like Eli Lilly and Zoetis--to help them do it.
AstraZeneca and Bristol-Myers Squibb are heading back to the FDA with the once-spurned dapagliflozin, claiming they've addressed the diabetes drug's cancer risks, but agency staff remains wary of the novel treatment's dangers.
The pharma giant is recruiting new patients while expanding the program with a new Phase III study for early-stage patients--without changing the dosing regimen.
With the American Society of Hematology meeting in New Orleans, a slew of blood cancer studies are in the spotlight. Three of the releases caught our eye, because they're significant new data on drugs already on the market.
Massachusetts CRO Agilux Laboratories has expanded its in vivo pharmacokinetics footprint, boosting its ability to run preclinical drug-response tests for a growing list of clients.
Biopharma researchers have accrued a huge library of chemical safety data over the past 60 years, but--as is often the case--much of it is tied up in formats that make computational analysis impossible.
The European Medicines Agency has decided to look again at the clotting risks of Ariad Pharmaceuticals' troubled cancer drug Iclusig.
Ariad Pharmaceuticals seemed to dodge a bullet last month when the European Medicines Agency chose not to follow its U.S. counterpart, letting the troubled Iclusig stay on the market. Now, the regulator is reopening the books on Ariad's cancer drug, reviving concerns about the company's sole product and sending its shares down about 10%.
FDA staff has taken issue with Takeda Pharmaceutical's vedolizumab, warning that the treatment for inflammatory bowel diseases could put patients at risk for a rare but deadly brain infection, possibly outweighing its benefits.