Gloucester’s NDA For Romidepsin In CTCL Is Targeted For Submission By Year End
This article was originally published in The Pink Sheet Daily
Company will present pivotal trial data on the HDAC inhibitor at the American Society of Hematology in December.
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Two subtypes of T-cell mediated lymphomas have been very difficult to treat using the existing cytotoxic chemotherapy treatments. CTCL and peripheral T-cell lymphoma (PTCL) patients receiving chemotherapy may experience severe, dose-limiting toxicities and develop resistance to the therapy. Gloucester Pharmaceuticals Inc. is developing a treatment that potentially is more effective than chemo, the company says, and the National Institutes of Health is backing its development.
Part 2: High costs are built into the rare disease business model. Participants at a roundtable discussion led by Scrip at the J.P. Morgan Healthcare Conference talked about how much they are feeling the pressure on pricing.