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The new law presumes that “these agreements are anti-competitive and delay the entry of the generic drug into the market place,” notes the state’s Attorney General Xavier Becerra. Read More
Most enacted drug transparency laws are flawed because they don’t require the release of transaction prices at each stage of the pharmaceutical distribution process, according to researchers at the University of Southern California. Read More
In a vote on Thursday along mostly party lines, the House Committee on Education and Labor advanced the Lower Drug Costs Now Act of 2019 (H.R. 3) with an amendment that would empower HHS to negotiate with drugmakers on prices for more prescription drugs. Read More
The appeals court found that PTAB misread the prior works Apotex presented and found that they “do not provide substantial evidence” to support the board’s finding. Read More
Buttigieg’s proposal would take advantage of provisions of the Bayh-Doyle Act to “acquire” companies’ intellectual property when price negotiations fail. Read More
The FDA outlined when sponsors can seek waivers, reductions or refunds of Prescription Drug User Fee Act (PDUFA) fees, in a final guidance released on Wednesday. Read More
The FDA’s Antimicrobial Drugs Advisory Committee voted 14-2 on Wednesday to support Shionogi’s NDA for cefiderocol lyophilized powder for IV administration to treat complicated urinary tract infection (cUTI). Read More
Jury selection began on Wednesday in the Northern District of Ohio for the nation’s first federal bellwether trial in the opioid crisis, as more defendants scrambled to settle before the trial gets underway on Oct. 21. Read More