How much Senate Democrats oppose President Donald Trump's new nominee to take over the reins of the FDA could depend on whom they dislike or distrust more – Stephen Hahn, the nominee, or Brett Giroir, who just became the new acting FDA commissioner.
Shares in Aveo Pharmaceutical Inc. (NASDAQ:AVEO), commonly called Aveo Oncology, fell 36.7% Monday to 57 cents after the FDA dashed hopes that positive interim data from a late-stage study of tivozanib would overcome agency concerns about the drug's efficacy in relapsed/refractory renal cell carcinoma (RCC). Advised by the regulator not to submit an NDA at this time, Aveo now plans to collect more mature data ahead of filing its NDA in the first quarter of 2020. A discussion with the FDA's Oncologic Drug Advisory Committee will likely be required too, the agency said.
How vulnerable is the U.S. biopharma supply if China were to halt exports of active pharmaceutical ingredients (APIs)? No one knows. "We cannot assess the extent of U.S. dependence on China," Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research (CDER), said in testimony to a House subcommittee Wednesday.
Amag Pharmaceuticals Inc.'s argument for keeping Makena on the market without having to conduct a new trial went nowhere Tuesday as an advisory committee struggled with conflicting efficacy data for the preterm birth drug that received accelerated approval eight years ago.
The third time is proving not to be so charming for Agile Therapeutics Inc. as it prepares its lead candidate for a date Wednesday with the FDA's Bone, Reproductive and Urologic Drugs Advisory Committee.
In another marathon session Tuesday, the third U.S. House committee with jurisdiction over prescription drug pricing issues marked up H.R. 3, the Lower Drug Costs Now Act, clearing the way for a House vote on the partisan measure yet this month.
The ideological divide between Republicans and Democrats proved to be an uncrossable chasm Thursday as two U.S. House committees marked up H.R. 3, the Lower Drug Costs Now Act, and a third committee held its first hearing on the bill that was crafted behind the closed doors of Speaker Nancy Pelosi's (D-Calif.) office.
With little more than a month to go before a trial begins in a multidistrict litigation (MDL) against several opioid manufacturers, privately owned Purdue Pharma LP is continuing its efforts to settle with all the plaintiffs involved.
Depending on who's talking, the U.S. patent system may, or may not, be in dire need of reform. In a Senate Judiciary subcommittee hearing Wednesday on the bipartisan STRONGER Patents Act, Sen. Chris Coons (D-Del.) stressed the need to undo the precedent set by the Supreme Court's 13-year-old eBay decision that weakened injunctive relief in infringement cases and to resolve some of the unintended consequences of the 2011 America Invents Act (AIA).
Whether it's mere political posturing or a genuine prescription to control U.S. drug prices, a Democratic plan taking shape in the House provides an idea of what direct government negotiation might look like.
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