Merck’s Quality-Of-Life Argument For Ridaforolimus Draws ODAC Tongue-Lashing
The pivotal study failed to capture patient-reported outcomes data on drug-related side effects, and use of observational data to support the view that the mTOR inhibitor has a positive risk/benefit profile is “crazy,” committee members said.
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AMAG outlines plans for retrospective real-world evidence studies, and possibly a new placebo-controlled trial with a primary endpoint of preterm birth <32 weeks, in a filing opposing the Center for Drug Evaluation and Research’s proposal to withdraw the drug.