Boehringer Ingelheim has agreed to pay $650 million to wrap up thousands of lawsuits claiming Pradaxa, an anticoagulant, caused serious--even fatal--bleeding in some patients. The deal comes just weeks after the FDA completed a safety review of the drug, concluding that it was as safe as the older drug it seeks to replace, warfarin.
With the list of generic drugmakers in the FDA's bad books growing longer by the week, how to improve evaluation of its drugs was a top priority when the agency recently compiled its regulatory science goals.
California has decided to lay the responsibility for opioid overdoses, and even a resurgence in heroin use, at the feet of the drugmakers, accusing them in a lawsuit of reaping huge profits while turning a large swath of people into drug addicts.
On Thursday, Takeda Pharmaceutical fended off a lawsuit by two women ages, 80 and 81, who wanted $1 billion in actual damages, claiming they suffered bladder cancer as a result of taking the company's diabetes drug Actos.
The company is recalling about 40,000 bottles of drugs manufactured for it by Emcure Pharmaceuticals in India for deviations in lab testing, an issue the FDA has frequently uncovered at Indian plants.
The FDA this week sent U.S. Marshals into an Ohio warehouse to seize more than $11 million worth of drugs marketed by Ascend Pharmaceuticals which it claims are unapproved. But a mention in the FDA press release that the drugs were warehoused by Masters Pharmaceutical has brought a world of pain down on the third-party logistics company.
In federal court in Las Vegas, a trial over the cancer risks of Takeda's Actos drug wrapped up Tuesday, leaving the jury to decide whether the diabetes remedy triggered the plaintiffs' disease--and if so, how much they should collect from the Japanese drugmaker.
India's Sun Pharmaceutical intends to be the white knight that will turn around manufacturing problems at Ranbaxy Laboratories once it finalizes its $3.2 billion buyout of the troubled drugmaker.
An FDA warning letter for a now banned Sun Pharmaceutical plant in India shows employees routinely deleted records of batch failures then retested drugs, reporting they met the standards that they previously couldn't hit.
The FDA sent U.S. Marshals in to seize more than $11 million worth of drugs from Ascend Laboratories, a subsidiary of Indian drugmaker Alkem Laboratories, saying the company never got them approved.