The FDA is moving toward real-time, continuous clinical trial oversight, starting with oncology studies run by AstraZeneca and Amgen. The agency says reviewers will access trial data as it accrues, aiming to shorten reporting lags and speed decision-making. In parallel, multiple FDA-related updates underscore a push toward faster, more data-rich evaluation pathways. The plans build on earlier proof-of-concept trials already initiated by the two companies, with the pilot relying on a real-time data platform provided by Paradigm Health. Separately, U.S. Supreme Court arguments set up a potentially industry-wide ripple effect for generics using “skinny labels.” The dispute in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma Inc. could influence how patent carving for specific indications is handled, affecting incentives for new indication development and generic entry strategies.
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