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Maryland’s state Senate has voted to overrule Gov. Larry Hogan’s veto of a bill to fund the state’s Prescription Drug Affordability Board (PDAB), an independent entity meant to cap prices for costly drugs in the state by 2022. Read More
Medicare Part D pays twice as much on average for hundreds of drugs as the Department of Veterans Affairs (VA), mostly because VA negotiates prices directly with drugmakers, the Government Accountability Office (GAO) has found in a new analysis. Read More
AstraZeneca (AZ), Sanofi and Eli Lilly have each filed lawsuits against HHS, arguing the federal government can’t force them to provide 340B drug discounts to contract pharmacies. Read More
Internal European Medicines Agency (EMA) documents on pending approvals of COVID-19 vaccines were hacked and leaked online, the agency said last week. Read More
Another last-minute Trump administration policy was issued at the end of last week by HHS that requires five-year, renewable term limits for directors of all agencies under the department, including the FDA. Read More
The COVID-19 pandemic has brought out many of the FDA’s strengths, including its commitment to science-based decisionmaking, according to a new report on the agency’s Pandemic Recovery and Preparedness Plan (PREPP) initiative that includes a dozen recommendations for improving the agency’s response going forward. Read More
Former FDA Commissioner David Kessler is set to become Operation Warp Speed’s new chief science officer as just a single day remains until the Biden presidency takes up the mantle for accelerating COVID-19 vaccinations and countermeasures. Read More
FDA veteran Janet Woodcock has reportedly been short-listed by the incoming Biden administration to serve as the agency’s next commissioner and will also likely serve as acting chief until the position is filled. Read More
The Endocrine Society, a large physicians’ group, is calling on policymakers to include government negotiation as part of an overall strategy to reduce insulin prices. Read More
The Pharmaceutical Care Management Association (PCMA) has filed a lawsuit to halt implementation of President Trump’s drug pricing policy that aims to prevent drugmakers and pharmacy benefit managers from negotiating rebates on prescription medicines. Read More
Eli Lilly CEO David Ricks has expressed concern that the new variant of the coronavirus that causes COVID-19 first reported in South Africa might be resistant to the company’s antibody treatment bamlanivimab. Read More
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