Clinical trial strategies proposed in FDA's draft guidance for co-development of drugs designed for use in combination in most cases whittle the design down to standard of care versus the combination before Phase III, offering the prospect of cutting not only development time but also clinical trial costs.
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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.’
President Trump’s new Executive Order on drug pricing reprises several policy themes from his first administration, including giving the FDA many tasks intended to increase competition in the marketplace.
FDA Commissioner Martin Makary will give industry a new avenue for access and influence despite his and HHS Secretary Robert F. Kennedy Jr.’s claims that the pharma-FDA relationship is too cozy.
The European Medicines Agency’s chief medical officer Steffen Thistrup argued that patients are able to understand the “complex regulatory and scientific issues” that the EMA committees discuss when they assess drugs.
