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The European Medicines Agency (EMA) has advised against the use of Merck’s anti-parasitic drug Stromectol (ivermectin) for the prevention and treatment of COVID-19. Read More
As the EU’s COVID-19 vaccine supply woes intensify, the 27-member bloc is signaling it could make good on its threat to halt exports of vaccine doses to the UK as soon as this week. Read More
The FDA has promised transparency as it implements data and technology modernization initiatives in its latest discussions with industry ahead of the next reauthorization of the Prescription Drug User Fee Act (PDUFA). Read More
PhRMA is still battling a final rule from the Trump Administration era to allow in pharmaceuticals from Canada and has filed a citizen’s petition asking the FDA to block New Mexico’s plan for importing drugs. Read More
The FDA’s Center for Biologics Evaluation and Research (CBER) has released a five-year strategic plan for 2021-2025 that outlines in broad terms how the center will use advances in science and technology — including increased use of real-world data (RWD) in clinical trials — to help achieve four main goals. Read More
HHS is postponing implementation of a final rule issued late in the Trump administration that would have required the FDA to review practically every regulation it has and redirect resources away from pandemic relief efforts. Read More
The Senate confirmed Xavier Becerra as HHS secretary yesterday in a narrow 50-49 vote, with just one Republican siding with Democrats to support his confirmation and the closest vote so far for any of President Biden’s Cabinet nominations. Read More
Despite the unprecedented disruption and shift in priorities that COVID-19 brought to FDA’s Office of New Drugs (OND) in 2020, the office approved 53 novel drugs, published 31 new guidances and wrapped up the reorganization it had been working on since 2019, said Peter Stein, OND’s director, in the office’s annual report. Read More
Top U.S. health officials, including an FDA regulator testified on Capitol Hill this week that real-world evidence from people vaccinated against COVID-19 and data from ongoing trials will be used to decide how vaccines should be updated to handle variant strains. Read More