Rx Sampling In "Spotlight" Of Boston Grand Jury As Part Of TAP Investigation
• By The Pink Sheet
Pharmaceutical companies should consider how their sampling programs will look in "the very bright spotlight of a federal grand jury investigation," Boston Assistant U.S. Attorney Michael Loucks said during the Food & Drug Law Institute annual meeting April 19 in Washington, D.C.
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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The FDA recommended removal of a voluntary hold on shipments of the gene therapy to younger patients after finding that the death of an 8-year-old boy in Brazil was unrelated to Elevidys. Discussions on safety of DMD treatment for non-ambulatory patients is ongoing.
While the 15% rate is a substantial blow for pharmaceutical firms, the US-EU deal provides a framework for trade agreements with other countries that could see the industry avoiding higher tariffs elsewhere.