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The European Medicines Agency is establishing a task force to implement common standards for identifying medicines across EU member states, and will require industry and regulators to comply with them beginning in July 2016. Read More
AstraZeneca will shell out $7.9 million to settle a lawsuit alleging it paid a pharmacy benefit manager to include its blockbuster heartburn drug Nexium on some formularies at the exclusion of other heartburn medications. Read More
A New Jersey-based drug compounder and two of its top corporate officials have been indicted on fraud charges for repackaging and distributing unsterile drugs to several states. Read More
Drugmakers should review their inspection standard operating procedures for producing off-site records and allowing FDA investigators to take photos or conduct interviews of employees, following new agency guidance on the topics. Read More
The FDA warned an Indian manufacturer to immediately stop ignoring poor test results, becoming another Indian facility to get a warning letter for data integrity violations. Read More
Five Industry groups are jointly launching a new data center, the European Medicines Verification Organization, to help eliminate counterfeit drugs from the drug supply chain. Read More
The FDA has accepted Apotex’s BLA for a biosimilar of Amgen’s blockbuster chemotherapy product Neupogen, the Canadian generics maker said Tuesday, making it the fifth publicly disclosed biosimilar application in the U.S. Read More