Advisory Committee Splits The Difference On CABP Trials
A fierce dispute between researchers and clinicians who think community-acquired bacterial pneumonia drugs should be evaluated by their effect on mortality, and those who favor symptom-based evaluation, is unlikely to be quelled by actions taken at the Dec. 9 meeting of FDA's Anti-Infective Drugs Advisory Committee, which gave each side some of what it wanted
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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.’
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The rollout of Trump’s plan has been a policy whiplash, but despite a 90-day pause on tariffs, the US president still appears to be holding a grudge with industry over drug pricing.
Proposals to reform Spain’s reference pricing system are out of whack with the national pharmaceutical strategy published in December, six industry associations have warned.
Israel has introduced a new framework to expedite the marketing approval of medicines, make the country a more attractive destination for drug registration and help reduce drug prices through market competition.