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Michael McCaughan

Michael McCaughan has has 25 years of experience providing analysis and insight about the biopharma industry, including 10 years as Editor-In-Chief of The Pink Sheet and The Pink Sheet DAILY. He speaks frequently on regulatory and policy developments affecting the industry.
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Latest From Michael McCaughan

Real-World Evidence Fails Another Test At US FDA

Correvio’s attempt to move vernakalant from 'clinical hold' to 'FDA approved' was a huge long shot. But the advisory committee vote – and looming FDA rejection – are another indication that real-world data is not a panacea.

Real-World Evidence Cardiovascular

The Absurd Innovation Debate: Dueling Views Of HR 3 Miss The Point

White House Council of Economic Advisors says US House drug price “negotiation” bill will reduce the number of innovative medicines by 100 over a decade; the Congressional Budget Office says more like 8-15. Both analyses miss the point – but also show that industry is losing a crucial piece of political ground.

Pricing Debate Research & Development

US FDA Office Of New Drugs Reorg: Phase 3 Pushed To January

The FDA has confirmed the picks to head most of the new offices in the restructured drug review organization, with one notable exception. The choice for the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine is still pending, while one candidate ­– Hylton Joffe – will be serving as acting OND deputy director.

FDA Leadership

A Year Of Reconsiderations For US FDA Advisory Committees

Correvio’s anti-arrhythmic vernakalant is returning to an advisory committee a dozen years after its first review, continuing a recent pattern of return visits for applications – and 12 years isn’t even close to the longest long back for US FDA panel in 2019.

Advisory Committees Drug Review

US FDA Nominee Makes A Good First Impression, But This Is Still An Odd Transition

Stephen Hahn mostly coasted through a confirmation hearing to be the next FDA commissioner – but he still didn’t really give any indication of why he wants the job.

FDA Leadership

New Tech Payment For Old Antibiotics: US Medicare Effort Brings Lots Of Interest

CMS streamlined process for enhanced payments is having an impact: seven antibiotic applications for New Technology Add-On Payment status in 2021—including one for a product that has been marketed for more than five years.

Infectious Diseases Reimbursement
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