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Spain’s Agency of Medicines and Medical Devices has ordered Madrid vaccine maker Angulema to suspend manufacturing and recall drug batches over GMP deficiencies. Read More
Small businesses sponsoring approved generics can expect a 90 percent discount on annual user fees, offering them some relief when GDUFA II takes effect in fiscal 2018. Read More
Dozens of healthcare organizations, including several drugmakers and payers, wrote an open letter to President Donald Trump, urging him and Congress to continue the pursuit of value-based care. Read More
The FDA rejected two citizen petitions urging the agency to allow biosimilar sponsors to use the same nonproprietary names as their reference products, finding them incompatible with final guidance on the agency’s naming scheme published earlier this month. Read More
Pressed for details by a Senate committee Tuesday, Rep. Tom Price (R-Ga.) — President Donald Trump’s pick to lead HHS — refused to confirm whether or not he would push for the power to negotiate Medicare drug prices, but said he was open to ideas. Read More
The European Medicines Agency said 30 drugs across four therapeutic classes have received conditional marketing authorization in the EU since the expedited approval pathway became available a decade ago. Read More