AstraZeneca’s Gout Treatment OK, But Post-Marketing Studies Needed
This article was originally published in The Pink Sheet Daily
FDA's Arthritis Drugs Advisory Committee recommends approval of lesinurad despite concerns about safety.
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The $1.26 billion buyout comes as the pharma is looking to bolt-on acquisitions to help offset recent late-stage pipeline disappointments and sees Ardea’s lesinurad as a potential improvement in gout therapy, an estimated $2 billion global market.
CBER Director Peter Marks said more sophisticated manufacturing expected in the next decade could lead to questions about whether gene therapies should be regulated by his center or CDRH.
Agency employees will have on-site, telework and remote possibilities, but options will depend on the center, office and job duties.