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As the Biden administration prepares to take over on Jan. 20, HHS has issued three new regulatory policies that it says will increase transparency and efficiency for the agencies it oversees, including the FDA. Read More
Operation Warp Speed (OWS)’s chief adviser Moncef Slaoui submitted his resignation Tuesday but said he will stay on in that role for 30 days after Jan. 21 to support the incoming administration. Read More
As Johnson & Johnson (J&J) nears the release of critical phase 3 trial results and potential emergency authorization for its promising COVID-19 vaccine, the company has reportedly hit speedbumps in manufacturing doses. Read More
A last-minute proposal by the outgoing Trump administration would weaken one of the few tools the federal government has to directly reduce the price of new prescription drugs. Read More
The Institute for Clinical and Economic Review (ICER) points out seven high-cost treatments whose prices were raised in 2019 without supportive clinical data and cost the U.S. health system $1.2 billion in annual drug spending, in a new analysis released Tuesday. Read More
HHS announced yesterday it will no longer stockpile millions of COVID-19 vaccine doses held to ensure Americans receive their second shot, but will distribute them immediately and give states two weeks to comply with new federal rules for dose allocation. Read More
The ongoing rifts between HHS and the FDA continued this week with confusion surrounding the department’s selection of James Lawrence as the agency’s chief counsel, just hours after FDA Commissioner Stephen Hahn announced a different pick to agency staff. Read More
AstraZeneca (AZ) has filed for EU approval of its COVID-19 vaccine and a conditional marketing authorization is expected in late January following a Jan. 29 meeting of the European Medicines Agency’s (EMA) expert panel on human medicines. Read More