It was way back in 2009 when the FDA first indicated it was worried about reports of heart attacks and strokes in patients taking Xolair, the asthma treatment co-marketed by Novartis and Roche. Now the agency is taking action, slapping new warnings to the product's label confirming that it's associated with cardiovascular risks.
The FDA polished up the official label on Pfizer's stop-smoking drug Chantix earlier this week. It was a victory for Pfizer, the payoff from several studies testing the drug for psychiatric side effects. Essentially, the new label will include study data suggesting that patients using the drug might not be at a greater risk of psychiatric problems after all.
Eye drug delivery outfit Novaliq touted a positive Phase I for its cyclosporin eye drops designed to treat dry eye disease. Novaliq's semifluorinated alkane technology allows for a clear solution of cyclosporin, which is poorly soluble in water, thus making for a more effective eye drop that doesn't impair vision, the company says.
A growing buzz about potential safety issues has raised a cloud of doubt about Merck's osteoporosis drug odanacatib, which is likely to linger now that the pharma giant has released Phase III results and laid out plans for a delayed FDA filing.
The nonprofit Cochrane Collaboration, which reviews clinical trial data to determine the value of pharmaceuticals, is going after Lucentis, which is used to treat the blinding eye disease age-related macular degeneration.
In a desperate attempt to control the ongoing Ebola outbreak in West Africa, the World Health Organization is appealing to drug companies and international regulatory bodies to work together to get experimental therapies and vaccines out of the lab and into the clinic as soon as possible.
With a Sept. 17 meeting on the horizon to discuss the risks and benefits of testosterone-raising meds--so-called Low-T drugs--the FDA has posted a review on the topic. But its stance is neither here nor there.
China has interrupted another group it says was illegally manufacturing capsules from chromium-laced gelatin. A lot of them.
Boehringer Ingelheim is finding it difficult to get the stink of the troubled Ben Venue Bedford, OH, operations off its shoes. It closed the site last year and sold it last month but is still having to recall products produced there that might be contaminated.
Legal experts have insisted there is no way that a $9 billion punitive damage award against Takeda Pharmaceutical and Eli Lilly for hiding Actos risks can stand. But the two companies are still sweating that one out after a federal judge refused to throw out the verdict and its mammoth award on Thursday.