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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
The UK BioIndustry Association and EuropaBio are calling for European regulators to drop plans to Phase I clinical trial reports, saying the information they contain is commercially sensitive. 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
The FTC is demanding Cephalon pay as much as $4 billion as punishment for profiting illegally from pay-for-delay deals that put off generic versions of the company’s wakefulness drug Provigil from 2006 to 2012. Read More