Pfizer’s new research contract with Medco is designed to enhance the drug firm’s targeted medicine programs by applying the pharmacy benefit manager’s repository of “real world data” to product development and marketing efforts.
Under the three-year contract (with options to renew), Pfizer and Medco will identify and evaluate patient subgroups in which investigational and marketed drugs are shown to be most effective. Work...
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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A new pilot aims to take Brazil closer to ‘digital transformation.’
Australia is reviewing its human tissue laws for the first time in almost 50 years, and is hoping to reduce barriers to access for scientific researchers, for instance by addressing issues with access to cell lines for developing drugs.
At this year’s DIA China meeting, the national regulator updated its policy focus areas for this year, including clinical trial data protection and pilot projects to shorten IND approval times.
CBER's Nicole Verdun wants rare disease sponsors with stalled treatments to circle back because the FDA's evolved thinking on clinical trial designs may offer another opportunity for cast away products.
