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.
The European Medicines Agency is looking for generic drugmakers to participate in a pilot program aimed at coordinating product approvals across international borders. It should also cut down on approval costs, which could translate to cheaper prices. Read More
European and Canadian trade negotiators reportedly have finalized the text of an historic deal that will bring Canada’s intellectual property regulations closer to those of the EU. But it could be another two years before the agreement is actually implemented. Read More
The incoming head of the European Commission has taken drug regulating responsibilities away from the EU’s health and consumers department and given them to the government’s enterprise and industry department, a decision that was welcomed by a European pharma trade group but criticized by consumers and some lawmakers. Read More
A federal judge has denied a motion by Merck to dismiss two lawsuits involving its mumps vaccine, one by whistleblowers alleging the company presented misleading efficacy data on the vaccine, and another by direct purchasers who contend the company created a monopoly on the product. Read More
Regulatory challenges in interpreting data from multiregional clinical trials have prompted the International Conference on Harmonisation to prepare a guideline on trial planning and design according to a recent concept paper. Read More
Drugmakers could see their wait time to begin clinical trials in Brazil cut by more than a third under a proposed regulation calling for protocols to be reviewed in their entirety, rather than in stages, as is the current policy. Read More
The FDA said yesterday that Justice Department official Cynthia Schnedar will become director of CDER’s Office of Compliance starting Oct. 6. Read More
European regulators have approved Eli Lilly and Boehringer Ingelheim’s insulin glargine drug Abasria, a biosimilar version of Sanofi’s blockbuster product Lantus. Read More
The FDA denied Teva its 180-day exclusivity period for a version of Warner Chilcott’s osteoporosis drug Actonel 150 mg because the agency itself didn’t tentatively approve Teva’s ANDA fast enough, according to an internal agency document. Read More
Canadian generics maker Apotex has lost a $520 million suit that the firm brought in front of an international arbitration board against the FDA over import alerts on two of its facilities. Read More
The FDA has warned four generic drug manufacturing facilities that they haven’t paid their GDUFA fees for the last two fiscal years, meaning all of their products are automatically misbranded. Read More