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Biologics sponsors will only need to report minor postapproval manufacturing changes on an annual basis, said the FDA in a new draft guidance. Read More
The Drug Enforcement Administration is proposing to lower its annual manufacturing limits on certain controlled substances for 2018 — which would cut back production of several classes of opioid painkillers and other scheduled pharmaceuticals, some between 10 and 25 percent. Read More
The development of a vaccine to treat addiction represents an “incredibly exciting” initiative in the nationwide fight against opioid abuse, HHS Secretary Tom Price said Tuesday. Read More
Under the decree, Isomeric Pharmacy Solutions is prohibited from storing, processing, manufacturing or distributing drugs until it complies with FDA regulations. Read More
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