GlaxoSmithKline set up a dermatology manufacturing center of excellence in the U.K. several years ago. But its manufacturing of its Bactroban products has proven to be less than excellent of late, leading to the recall of more than a quarter of a million tubes of antibiotic cream that may be contaminated.
Pfizer has been trotting out positive study data to try to convince the FDA to revoke a black-box warning on its smoking cessation drug Chantix tied to serious psychiatric side effects. Now the company is touting a new study which shows that Chantix does not increase certain cardiovascular or psychiatric symptoms and that it should be recommended for more smokers.
In a recent editorial that appeared in a publication focused on poultry health, a veterinarian cautioned that the movement against using antibiotics and other drugs in production animals is limiting the ability of vets to do their job.
Johnson & Johnson and Bayer are leading the four-horse race among new-age anticoagulants, and they're hoping some new real-world safety data for Xarelto can help keep the med in the No. 1 spot.
Earlier this year, AstraZeneca touted positive Brilinta (ticagrelor) data from its PEGASUS trial, which found that long-term use of the drug plus aspirin helped prevent heart attacks, strokes and cardiovascular death in post heart-attack patients--and did so better than long-term aspirin plus placebo. And now, AstraZeneca is armed with new details from the study, showing that stopping Brilinta therapy too soon can heighten risks of those very events, helping make the case for long-term use of the drug.
As if last week's Jardiance news wasn't enough to worry makers of DPP-4 diabetes drugs, the FDA has now issued a warning that the class of meds might cause "severe and disabling" joint pain.
Back in June, researchers unveiled details of the ELIXA trial, which put Sanofi's Lyxumia in the clear as far as cardiovascular safety risks go. Now, a new analysis of the study shows that in Type 2 patients with acute coronary syndrome, the diabetes med didn't increase the rate of cardiovascular events--but it didn't decrease it, either.
The good news keeps rolling in for Merck when it comes to the cardiovascular safety of its DPP-4 inhibitor, Januvia. According to a new analysis of the TECOS trial, patients with Type 2 diabetes and cardiovascular disease--even those with a history of heart failure--can take the drug without an increased risk of CV complications.
A few months ago, the European Medicines Agency followed through on a threatened continental marketing halt affecting about 700 drugs in Indian CRO GVK Biosciences' generic lineup due to allegations of manipulated trial results. Now, Germany's regulators have suspended another 54 drugs tested by GVK in accordance with the EMA's recommendations.
Allergan Monday said it was going to pull some of its eye drugs from the market because of a problem with particles shedding from the tube cap which led to a "small number of customer complaints." The small number is nearly two dozen, including 12 consumers who said they had a foreign object in their eye as well as one report of swelling and another of blurred vision.