Two PhRMA-funded surveys found that payers and providers would like more information from biopharmaceutical companies about approved and unapproved uses of medicines, including products undergoing clinical trials. Source: Drug Industry…

The FDA should not approve generics of Glaxo Smith Kline’s asthma drug Advair Diskus that depend on multiple-batch studies to show pharmacokinetic bioequivalence, according to Mylan. Source: Drug Industry Daily

Most drugmakers are fulfilling their postmarketing study commitments, but many are not meeting their deadlines for annual status reports, the FDA said. Source: Drug Industry Daily

U.S. healthcare spending growth slowed in 2016, including a steep drop in spending on retail prescription drugs — decelerating after two years of faster growth associated with coverage expansions under…

An FDA advisory committee voted unanimously in favor of combining patients with bladder pain syndrome and interstitial cystitis in clinical trials citing the minimal differences in symptoms between the two…

The FDA is planning to deliver a suite of disease-specific guidance documents next year on developing targeted gene therapies, starting with hemophilia and then more common single-gene disorders, Commissioner Scott…