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Concert’s CTP-543 would be second or third to market in alopecia areata, behind Lilly and likely Pfizer, but the biotech thinks its drug will have the best profile based on efficacy and patient satisfaction.
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
Japan is aiming for the betterment of pharma R&D and medical services for rare disease patients by building a database connecting genome analysis data and clinical records. While several clinical studies are planned for the next couple of years, there are also concerns around the actual trickle-down of benefits to patients and data privacy.
With the expectation for increasing amounts of patient experience data comes the need for the FDA and sponsors to consider, and account for, the degree to which open-label bias influences oncology trial PROs; agency staff suggest trial design elements and analytic approaches for dealing with bias at a meeting on cancer clinical outcomes assessments.
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