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.
With its deal last year to combine consumer health operations with Novartis in a joint venture that GlaxoSmithKline will run, GSK CEO Andrew Witty bet a big piece of the drugmaker's future on products like OTC pain meds and toothpaste. While Witty has lauded the future of that operation, it has stumbled in that market with the recall of nearly 4 million tubes of toothpaste products that may give users splinters.
Takeda's new CEO, Christophe Weber, thought the Japanese drugmaker had freed itself of the drag from thousands of lawsuits tied to cancer risks from its diabetes drug Actos with a $2.37 billion settlement offer made in April. But despite an average promised payout of $250,000, many plaintiffs have not signed on, perhaps because the rewards of suing seem so much more enticing.
Chinese CRO WuXi PharmaTech, alongside partner TruTag Technologies, is developing tiny, edible bar codes designed to prevent drug counterfeiting, and the technology cleared its first hurdle.
Roche has been on a legal roller coaster with its acne drug Accutane. Facing thousands of claims that the drug triggers inflammatory bowel disease, the Swiss drugmaker is now enjoying a high point, as an appeals court reversed a $25 million verdict against the company.
Eli Lilly scored a victory in the first U.S. trial over claims of withdrawal symptoms linked to its blockbuster antidepressant, Cymbalta, as a federal jury found the drugmaker was not responsible for side effects such as brain zaps and suicidal ideations in a patient who quit the med.