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Unlicensed Stem Cell Clinics Are 'Surrogate' For Right To Try, US FDA's Marks Says

CBER director said unlicensed stem cell clinics often report adverse events not made public, which is a concern under Right To Try.
Drug Safety Clinical Trials

Medicare's Part B Reform Proposal May Be Gaining Momentum; Congress Not Hearing Strong Protests

Muted stakeholder reactions may reflect Trump Administration efforts to address physician concerns in its Medicare Part B drug payment reform.

Pricing Debate Medicare

UK Pharma Takes Hope From Draft Brexit Deal But Uncertainty Reigns

The Brexit deal agreed by UK ministers brings little certainty for the life sciences sector.  Moreover, the related and unprecedented political instability means that its final approval is far from guaranteed. 
Brexit Legislation

Triangulation Or The Bermuda Triangle: Can Trump Work With House Dems On Drug Prices?

President Trump is highlighting drug pricing as an area where he may be able to work with the new Democratic majority in the House. The political wisdom of building common ground on the topic is hard to ignore – but the tempestuous personality of the President is still the overriding factor. Instead, focus on whether HHS can win some breathing room to keep going with administrative changes.
Elections Pricing Debate

Gottlieb Renews Call For New Opioid Review Paradigm As Democrats Prepare For House Control

US FDA's controversial approval of Dsuvia may prompt incoming House Democrats to pay special attention to commissioner's remarks on how agency reviews opioids. 
Neurology Elections

US FDA May Largely Avoid House Democrats' Investigation Agenda

Drug pricing hearings likely will involve FDA, but most pressing issue facing agency following midterms may be whether Commissioner Gottlieb will depart.
Elections Legislation
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