Spectrum Puts Its Eggs In One Basket: Folotyn, Beleodaq To Share Confirmatory Trial
This article was originally published in The Pink Sheet Daily
With Spectrum’s Beleodaq’s accelerated approval for peripheral T-cell lymphoma, FDA rolls Folotyn accelerated approval requirement into one post-marketing trial that will provide answers on both drugs – including which is better against standard of care.
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The year-old pan-European biotech is targeting advanced liver cancer, severe mucositis and the rare cancer, peripheral T-cell lymphoma, for its first products in the orphan oncology niche.
Pharmaceutical Approvals Monthly takes stock of FDA’s performance at mid-year: CDER only needs to clear eight more novel agents to top 2013 in new molecular entity and novel biologic approvals, and priority and orphan drugs make up a higher portion of novel approvals than in recent years.
CDER only needs to clear nine more novel agents to top 2013 in new molecular entity and novel biologic approvals. Priority and orphan drugs make up a higher portion of CDER’s 2014 novel approvals than has been seen in recent years. “The Pink Sheet” takes stock of FDA’s performance at mid-year.