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.
Markets reacted very poorly when Biogen recently cut its earnings forecast on "headwinds" slowing Tecfidera sales because doctors are concerned about reports tying it to the rare but sometimes fatal brain infection known as PML. Now that wind has picked up after a report in a leading medical journal predicted more cases of the disease and called for deeper studies of the risks.
Earlier this year, a U.S. judge dealt Eli Lilly a stinging blow after refusing to toss out lawsuits claiming that the company downplayed withdrawal symptoms linked to its blockbuster antidepressant, Cymbalta. Now Lilly is facing the first U.S. trials over the claims, a critical moment as it attempts to disentangle itself from a raft of litigation.
An analysis by AdverseEvents shows the new generation of obesity meds are holding their own, safety-wise. Still, postmarketing data flag some serious cardiovascular and neuropsychiatric side effects that are worth monitoring, the healthcare informatics firm says.