The cost-effectiveness agency recommended that Bristol-Myers Squibb's widely embraced Yervoy (ipilimumab) should not be used as a first-line treatment for melanoma. The agency does recommend the drug for second-line treatment, but says BMS needs to do more clinical trials to prove its "clinical effectiveness" for earlier use.
In the last 6 months the FDA has banned two more Ranbaxy plants, leaving it with just one of 5 FDA-approved facilities able to serve the U.S. So the maker of generics will try yet again to put things right so that it can sell more products in its largest market.
Studies are popping up that highlight safety risks associated with testosterone drug use, and the FDA said last month it would reassess the issue after two years of monitoring. But so far, the agency hasn't drawn any conclusions on whether testosterone treatments increase the risk of stroke, heart attack or death--and so a public advocacy group is taking matters into its own hands.
A congressional hearing Wednesday will hear from researchers who contend that because of quality and manufacturing shortcomings, at least some generic drugs made outside the U.S. don't work as well as the branded drugs they copy. And the FDA is already looking deeper into the equivalency issue.
The FDA has taken some tough action against Indian drugmakers like Ranbaxy Laboratories. It has a dozen inspectors stationed in India and will beef that up to 19. But the agency doesn't have it out for Indian drugmakers, FDA Commissioner Margaret Hamburg insists. Its actions there just reflects that India has become one of the biggest links in the global supply chain.
Sales whistleblowers have struck again, this time landing Endo Health Solutions in a $193 million hole.
Bristol-Myers Squibb has picked up its second "breakthrough" drug designation for a daclatasvir-based, all-oral combo for hepatitis C from the FDA, potentially shaving some regulatory time off its late-stage program as developers scramble to hijack market share from Gilead's pioneering approach.
Any drugmaker knows that no matter what a drug's sticker price, its sales can only go as far as its patient pool will take it. So for Vertex, whose cystic fibrosis med Kalydeco had reached nearly all eligible patients in the U.S. and Europe, a new FDA approval to treat more CF sufferers is pretty significant.
Johnson & Johnson is moving ahead with its renal denervation program in the wake of Medtronic's major setback, winning CE marking for its Renlane renal denervation system, which doctors in Europe are already using to treat drug-resistant hypertension.
A European Medicines Agency committee has recommended approval for another COPD treatment from GlaxoSmithKline, setting the stage for a likely nod in the coming months as the drugmaker looks to bolster its respiratory franchise.