Hospira, which has continued its struggles with manufacturing quality, closed out the year with a recall, and it was a big one. The Illinois-based company issued a worldwide recall of the cancer med mitoxantrone that was manufactured at a plant in Australia that the FDA savaged in a warning letter last year for not figuring out why tests showed its potency was too low and its impurities too high.
Improprieties at a GVK Biosciences facility in India have led some European countries to pull medicines from shelves, and the resulting fallout is cutting into the CRO's profits.
Two recent surveys covered by FierceDrugDelivery have shown that the vast majority of patients don't use their drug delivery devices properly. Device training specialist Noble says improved patient education is the key.
A war of words has broken out over the past week between Eli Lilly's Elanco animal health division and the company's hometown newspaper, the Indianapolis Star. At issue is an overriding question that weighs on the minds of pet owners worldwide: Are medications for dogs and cats really safe?
A far-reaching indictment against 14 New England Compounding Center (NECC) owners and employees not only accuses them of peddling unsterile drugs that infected hundreds of patients with fungal meningitis, but also includes 25 murder charges against two lead pharmacists.
Drugmaker Pozen says its API supplier has done everything the FDA asked after noting issues in an April plant inspection and the company resubmitted its application in July. But the FDA's compliance division has been too busy to get back to the plant and see for itself, and so the agency has sent Pozen a second CRL with "identical wording."
A federal indictment alleges that the now-defunct New England Compounding Center reaped millions of dollars by cutting corners in the manufacture of what were supposed to be sterile drugs, falsifying records, using expired ingredients and lying to clients about their safety.
The evidence is clear: Patients don't properly use drug delivery devices like inhalers or epinephrine autoinjectors--such as Mylan's EpiPen.
A host of drugmakers will not have to pull from the market, at least for now, generic drugs that German regulators say are suspect. The companies have bought some time with appeals of a decision by regulators to nix sales of dozens of medications because of flaws in clinical trials handled by an Indian contractor.
The veterinary nonsteroidal anti-inflammatory drug diclofenac was banned in several South Asian countries after the product was linked to mass deaths of vultures there. But diclofenac was recently approved in Spain and Italy--sparking an outcry from an international team of veterinarians, conservationists, and biologists, who argue that the drug will put Europe's vultures at risk of extinction.