We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Japanese drugmaker Eisai’s U.S. subsidiary is selling and assigning its U.S., Canadian and Japanese development and marketing rights to Dacogen to Otsuka Pharmaceuticals. Read More
Massachusetts last week became the first state to ban Zogenix’s controversial painkiller Zohydro, a move that could lead other states to follow suit. Read More
The FDA Friday approved Janssen Pharmaceuticals’ Topamax for the prevention of migraines in adolescents, the first such drug for this age group. Read More
Drugmakers seeking certification that their products comply with the European Pharmacopoeia will soon face a two-step process for having their applications approved by the European Directorate for the Quality of Medicines & HealthCare. Read More
An FDA proposal to only allow stool for fecal matter transplants (FMT) from donors known to patients or their physicians has come under heavy fire from critics who argue it will actually make the procedure more risky and shut down stool banks. Read More
The European Medicines Agency approved a new, time-saving formulation for Roche’s MabThera Friday, positive news for the Swiss drugmaker as it tries to recoup the loss of European patent protection for its blockbuster cancer drug. Read More
Companies designing medical device trials for children can use age as a starting point to categorize the patient population, but other physiological and developmental factors should be taken into consideration as well, an FDA final guidance says. Read More
While manufacturers support a strong pharmacovigilance system to ensure patient safety, the proposed costs are a source of concern, “especially in light of the annual saving for the pharmaceutical industry of 145 million euros (US $201 million) that was anticipated in the 2008 European Commission ‘impact assessment,’” a coalition of five trade groups says. Read More
Ben Venue is working with the FDA on a recall of its acetylcysteine solution 10 percent USP after a single glass particle was found in just one vial of a lot of the drug, the company said last month. Read More