Michael McCaughan is a founding member of Prevision Policy LLC, a leading provider of regulatory and reimbursement policy analysis for the biopharma industry. He was previously the Editor-In-Chief of The Pink Sheet and remains a contributor to the publication.
Latest from Michael McCaughan
The US Food and Drug Administration updated obesity drug development draft guidance for the first time in almost 20 years and although a lot has changed in the field, the FDA’s fundamental expectations to support approval did not.
6 January 2025 will be remembered in Washington, DC, as the date Congress certified Donald Trump’s second presidential election victory and a snowstorm shut down most of the city, but for FDA watchers it will be the day the agency released more than two dozen new draft and final guidances.
Robert Temple, the US FDA’s most experienced drug regulator, is currently serving an emeritus role at the agency. The immediate impact of his departure will be mostly symbolic, but still unsettling.
Some pharma industry CEOs appear to have done well in their meeting with President-elect Donald Trump and his health care team.
The US Medicare agency’s proposal to cover weight loss drugs hinges on defining obesity as a disease. While the characterization matches the growing medical consensus, the incoming Trump Administration may not agree.
The agency wants sponsors to design clinical trials more carefully where overall survival is not the primary endpoint.