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.
After settling much of the litigation tied to the health effects on newborns whose mothers took the antidepressant Paxil during pregnancy, maker GlaxoSmithKline has now won a wrongful death case brought by a woman who said she aborted after she was told her fetus had congenital heart defects.
The good news for Daiichi Sankyo: Its new anticoagulant drug matched the old standard-issue drug warfarin at preventing stroke and blood clots. And as far as safety goes, edoxaban beat warfarin by a significant stretch. That's an entree into the warfarin-alternative market, expected to grow to $10 billion over the next several years.
Last year, Anthera Pharmaceuticals pulled the plug on its lead drug after the cardiovascular disease treatment ran into some insurmountable efficacy problems in Phase III but failed to mention that the now-discarded varespladib actually increased patients' risks of heart attack and stroke. The study's lead investigator said Anthera dragged its feet in releasing the data.
A Philadelphia jury didn't buy Johnson & Johnson's argument that it had properly warned doctors and patients about the birth-defect risks associated with its seizure drug Topamax. The panel ordered J&J's Janssen unit to pay $11 million to Haley Powell, whose son was born with a cleft palate.