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Latest From Brenda Sandburg
Commissioner worries that fewer drugs may enter market in some categories because of drug development costs, and offers some post-market strategies for encouraging biosimilar development.
Janssen, Teva, Allergan, Endo, and Purdue – as well as several distributors – pursued in multistate investigation that follows individual AG inquiries and flurry of state, city, and county suits.
Commissioner Gottlieb says FDA is looking to work with provider groups to set dosage based on indication; Patrick Kennedy is calling on CMS to provide reimbursement for opioid addiction treatment.
US advisory committee unanimously impressed by the 90% plus efficacy; FDA says label may note lack of data in those who've previously had shingles.
GlaxoSmithKline's vaccine has 97.16% efficacy, surpassing Merck's Zostavax, but US advisory committee will weigh risks from inflammation which could cause ocular adverse effects and gout.
Advisory committee agrees that risks of gadolinium retention in the brain and other organs need further study; actor Chuck Norris' wife was among several patients who testified of devastating medical problems following administration of agents.