Australia's Pharmaxis Says CF Drug Results Point To U.S. Application
This article was originally published in PharmAsia News
Executive SummaryPharmaxis of Australia said final-stage trial results for its Bronchitol (mannitol) drug for cystic fibrosis were successful enough to file for U.S. approval
You may also be interested in...
ICER president Steve Pearson is ‘cautiously optimistic’ that net pricing for acute migraine treatments will align with benefits once discounts are factored in.
Almost 50 novel agents are already under review at FDA for potential 2020 approval. Candidates are notably diverse, with concentrations in established strongholds (oncology, neuroscience), popular programs (breakthrough), and powerhouse sponsors (keep an eye on Bristol-Myers Squibb right out of the gate).
CBER is starting the year with four novel gene and cell therapy applications under review and rolling submissions underway for more.