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The European Medicines Agency plans to issue a “go-live” strategy for regulators, drug companies and other stakeholders in the run-up to the Nov. 22 launch of an upgraded EudraVigilance system for reporting adverse drug reactions. Read More
Hedge fund investors are suing generics manufacturer Teva for not being forthcoming about a federal price-fixing investigation — saying the company’s false statements before the eventual reveal of a subpoena resulted in losses of billions in shareholder value. Read More
The UK National Institute for Health and Care Excellence ruled that Merck’s cancer immunotherapy Keytruda is not cost-effective in metastatic urothelial carcinoma. Read More
A PET finished dose manufacturer in Ohio was cited by the FDA after investigators witnessed numerous cGMP violations and potential quality problems on a January 2014 site visit. Read More
The FDA found substantial sterility problems on a visit to Kansas-based ARJ Infusion Services, makers of in-home intravenous medications for adults and children with rare and chronic conditions. Read More
Ahead of the program’s expiration in September, the FDA has finalized a question-and-answer guidance for GDUFA I covering ANDA reviews, inspections and self-identification of facilities. Read More
Unable to resolve persistent manufacturing problems, New Jersey-based drugmaker Pacira Pharmaceuticals is ending production of its DepoCyt chemotherapy drug and closing the California plant where it is made. Read More
A federal judge has barred an Alabama compounder from manufacturing, holding or distributing drugs until the facility complies with FDA regulations. Read More