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The EU reassigned oversight of more than 370 centrally authorized drugs from UK agencies to other EU member states in anticipation of Brexit. Read More
A group of hemophilia patients and activists petitioned the FDA to hold a public hearing on court-ordered drug restrictions after an intellectual property suit filed by Shire requested restricted access for the hemophilia medication Hemlibra (emicizumab-kxwh). Read More
Rep. Keith Ellison (D-Minn.) questioned the appointment of CVS Caremark vice president and former Pfizer executive Daniel Best to oversee HHS drug pricing reforms in a letter to Secretary Alex Azar. Read More
Sens. Elizabeth Warren (D-Mass.) and Patty Murray (D-Wash.) prodded the White House to say what it’s doing to implement the 56 recommendations issued in November by the President’s Commission on Combating Drug Addiction and the Opioid Crisis. Read More
The FDA adopted an addendum updating the ICH’s E11 guideline on pediatric clinical trials, outlining ethical considerations, age classifications, pediatric drug formulations, practicalities in clinical trials and approaches to optimizing drug development. Read More
None of the 10 largest U.S. drugmakers have lowered prescription drug prices as a result of the tax reform passed in 2017, according to an analysis from the office of Sen. Cory Booker (D-N.J.). Read More
The European Commission issued revised guidance for regulatory authorities, marketing authorization applicants and holders on the listing of excipients on product labeling and package leaflets. Read More