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Members of FDA’s Oncologic Drugs Advisory Committee voted 14-1 yesterday to require a U.S. study for sintilimab, Lilly’s investigational lung cancer drug that — so far — only has Chinese trial data. Read More
Seventy-eight Republicans have thrown down the gauntlet in front of the Centers for Medicare & Medicaid Services (CMS), charging that limiting payments for Biogen’s Aduhelm pressures people with Alzheimer’s disease — especially minorities, the poor and the disabled — to participate in clinical trials if they want the drug. Read More
The European Medicines Agency (EMA) has announced a new center that will deliver a network of real-world data (RWD) sources across the EU for use in drug reviews. Read More
To try to avoid a government shutdown, the House has voted to extend the continuing resolution that’s funding the government through March 11. Read More
After hundreds of hours with a court-appointed mediator, the Sackler family appears ready to contribute more than the $4.3 billion they previously pledged in their settlement over the opioid crisis on behalf of their company, Purdue Pharma, the maker of OxyContin. Read More
Drug companies with a candidate nonopioid analgesic should consider applying for expedited review through FDA’s special approval pathways, according to new draft guidance released yesterday. Read More
The FDA’s Center for Drug Evaluation and Research (CDER) plans to publish almost 100 new and revised draft guidances this year, according to the center’s 2022 guidance agenda — about two-thirds of which were previously on CDER’s 2021 agenda. Read More
The FDA outlined clinical pharmacology considerations for developers of antibody-drug conjugates (ADCs) in a draft guidance released yesterday. Read More