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.
Ariad Pharmaceuticals is letting go of nearly half its U.S. staff just a week after pulling its leukemia drug Iclusig from the market at the FDA's request.
If you're a drug developer, which 6 words do you never, ever want to see in an FDA review of a potential new product? The 6 words applied to Sanofi's multiple sclerosis treatment Lemtrada: "serious and potentially fatal safety issues."
As more and more baby boomers have signed on for testosterone testing--and, in turn, therapy--worries about the safety of testosterone-boosting drugs have grown. Now, a new study in the Journal of the American Medical Association puts some numbers to that concern.
A year after Curis agreed to pay Genentech $9.5 million upfront to license the early-stage cancer therapy recoded as CUDC-427 and borrowed $30 million to launch its own study, the FDA has clamped a partial clinical hold on the program following the death of one patient taking the drug.
Australian Prana Biotechnology has published new data showing its metal-transporting compound PBT2 reversed memory and learning loss associated with the aging process in elderly mice.
The FDA has asked drugmakers to recall several products with dosing systems or potency variations that could lead to dangerous overdoses.
With a plummeting share price and grim prospects for its lead drug, Ariad Pharmaceuticals is adopting a shareholder rights plan to deter would-be corporate raiders, a move to protect what little value it has left.