AMAG’s Turnaround Plans Hit A Snag With Feraheme CRL
This article was originally published in The Pink Sheet Daily
FDA declined to approve the I.V. iron in a broad patient population and requested another clinical trial to further evaluate safety. The decision gives rival Daiichi more time to penetrate the market with its I.V. iron Injectafer.
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Luitpold citizen petition seeking to block AMAG’s expanded indication for injectable iron offers FDA an opportunity to weigh in on how similar trial designs must be for drugs with the same indication.
AMAG is looking to build out its portfolio by in-licensing or acquiring new commercial products that complement its I.V. iron product Feraheme. The company is in negotiations for multiple assets, while at the same time preparing to launch Feraheme into a broader patient population.
Two companies in the biopharma space began trading publicly this week, one to pay off debt, the other to fund an early-stage pipeline.