A new plan has been filed to establish a fund of at least $135 million in compensation for victims and families affected by a 2012 fungal meningitis outbreak that killed 64 people, sickened hundreds and led to Congress granting the FDA new powers to regulate compounding pharmacies.
Novartis' Fluad influenza vaccine has been declared safe by another regulator, this time the European Medicines Agency, after being called into question following the deaths of patients in Italy who had been given the jab.
Italy's drug regulator has a growing investigation on its hands, and Novartis is in the middle of it. The number of people who have died in the country after receiving one of the Swiss pharma giant's flu vaccines has risen by 10 just days after Italy issued a partial ban on the product.
When Biogen Idec reported last month that a patient taking its hot multiple sclerosis pill Tecfidera had developed a rare brain infection and died, the drugmaker said it believed the safety profile of the drug remained solid. Perhaps so, but the FDA has decided the death was important enough to add a description of it on Tecfidera labels.
For the second time in four months, Baxter International finds itself recalling highly concentrated potassium chloride. This time it's a labeling problem, one that the company says has the potential to be life-threatening.
Patients are overconfident in their ability to operate drug delivery medical devices and may not realize that they are using them incorrectly, a comprehensive survey by the U.K.'s Team Consulting shows.
How can the aquaculture industry lead the way to responsible use of antibiotics without sacrificing food safety and endangering human health? That question was posed recently by The Fish Site, published by U.K.-based agricultural data provider 5m.
Just as the dust is settling after the big rollout of doctor-payment data in the U.S., a new round has made its debut--in Japan. According to The Japan News, the country's top 10 drugmakers shelled out 190 billion yen ($1.66 billion) to doctors in fiscal 2013 in the form of research payments, speaking fees, entertainment, medical seminars and the like.
After crunching the data on Intercept's clinical study of OCA for nonalcoholic steatohepatitis, investigators say they tracked some distinct improvements for patients suffering from the liver disease. But they also fretted about some troubling safety issues as well as inadequate efficacy endpoints that will have to be carefully considered in follow-up studies, tempering some of the high excitement that has been stoked by some analysts and the biotech's investors ahead of a pivotal Phase III study.
When it comes to cattle feed additive Zilmax, pulled from the market last year on concerning side-effect reports, there's nothing to worry about, Merck says. After a comprehensive review, the drugmaker has determined the product is safe when used according to its label. Now it just has to convince the meat-packing industry.