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.
A European Medicines Agency probe found that Roche failed to flag tens of thousands of side-effect reports, EMA reviewers said. But sifting through those unreported adverse events didn't turn up any new safety worries on Roche's leading drugs, as some had feared.
Investigators at MIT may have found the key to designing the next generation of antibiotics--a toxin called SocAB that blocks DNA replication and inhibits bacterial growth.
Pharma naysayers have been known to accuse the industry of making drugs that cause side effects--and then making more drugs to treat those side effects. Now, a group of critics is taking aim at Zohydro, the new painkiller approved by FDA last month.
Four months after Sanofi wrote off its late-stage cancer drug iniparib as a total loss, the pharma giant has been forced by safety concerns to shutter its program for the JAK2 inhibitor fedratinib in another major blow to its efforts to develop a portfolio of oncology treatments.
With more power comes more responsibility. And generics makers know it. If the FDA follows through on a new rule allowing them the authority to update their own labels, then they'll be on the hook if they fail to.
As regulators the world over clamp down on biologics development, Covance has struck up a partnership with Pathoquest to offer next-generation sequencing-based tests for biotherapeutics.