Register for our free email digests:
Are you sure you'd like to remove this alert? You will no longer receive email updates about this topic.
Latest From Cole Werble
Biopharma sponsors are eagerly awaiting guidance on how to apply 'real-world evidence' to drug development and regulatory decisions. Recent workshops provide some clues about what is likely to be included in the first drafts.
Pfizer feels that orphan products may present a particularly good area for testing wearable monitors and other digital devices as research tools. The small patient populations and fine distinctions in functional improvement or delay of disease progression may be ideally suited for the digital collection of data.
Web tool to help patients find expanded access program should go live in early June, focusing initially on oncology. That timing should help deflect efforts to enact “Right to Try” legislation.
US agency's April 6 patient-focused drug development meeting on sarcopenia sent two very divergent messages about the status of measuring patient engagement on new drug development: both delivered by an unexpected messenger, former FDAer Ray Lipicky.
Experts from Prevision Policy discuss their initial impressions of Scott Gottlieb as President Trump's choice to lead FDA, his unique policy experience, what it means from the drug industry, 'Council of Elders' drug approvals, and how his selection could impact the user fee negotiations.
National Academies’ report on the fast-advancing genome-editing technologies points out that ways to improve musculature in dystrophy patients will almost certainly raise issues about treatment use in narrow population versus enhancement use in broader population. In most cases, however, specificity of genome-edited products will help limit use of the new therapies to targeted populations.