“The Pink Sheet” DAILY’s Most Popular Stories Last Week
This article was originally published in The Pink Sheet Daily
Executive Summary
Obesity and diabetes drug development and market issues drew the most attention from readers.
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Obesity Drug Approval Needs A New Paradigm, Stakeholder Group Says
Group convened by George Washington University School of Public Health and Health Services recommends a “patient-centered” approach to reviewing obesity drugs that includes assessing the therapies for their risks and benefits for obese individuals who are healthy, have risk factors for co-morbidities or impairments to daily feeling or functioning, or are already sick.
Ampyra Trial Failure Is Not All Bad News For Acorda
Lower dose of Acorda’s MS drug Ampyra fails to meet primary endpoint in new study, reassuring investors on the IP front. But the higher, approved dose also missed the mark, which raises questions about a negative commercial impact.
Tablet Scoring Guidance Could Drop Patient Testing Recommendation
FDA’s Advisory Committee for Pharmaceutical Science and Clinical Pharmacology unanimously rejects an idea to test tablet scoring in the relevant patient population, saying there is too much potential variability.