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The agency is sponsoring research into BE testing for long-acting periodontal drugs and developing methods for assessing generic injectables. Read More
The UK’s National Institute for Health and Care Excellence on Friday gave a preliminary nod to two diabetic macular edema products, paving the way for their eventual inclusion in the government’s formulary. Read More
Postmarket monitoring results on Hospira’s biosimilar of Janssen’s Remicade continue to show comparable patient response to the reference, the generics maker says. Read More
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