Latest From Kaiser Permanente
Biopharma industry urges agency to open the door wider to use of non-randomized observational studies to support efficacy claims, but insurer Kaiser Permanente calls such studies problematic.
Some patient groups, payers support CMS proposal to require disclosure of list prices in TV ads but want to expand the requirement to other media and beef up enforcement. Others are skeptical the proposal would lower prices.
CGRP inhibitors were a hot topic during third quarter earnings calls, with Amgen and Teva talking about reimbursement progress, while Lilly marked progress for its add-on treatment, Allergan calmed fears about Botox's migraine sales, and Alder said its intravenous drug is on track.
Agency releases open source code and technical documents for new mobile app designed to gather real-time information about medication use and patient-reported outcomes; app will be incorporated into several PCORI-funded studies that FDA is leveraging as it explores the regulatory utility of real-world data.
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