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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.

Latest From Michael McCaughan

MedPAC’s Message To Congress: Drug Pricing Still Needs Attention

The US Medicare Payment Advisory Commission is continuing its work on proposals to overhaul federal payment for physician administered drugs. That is an ominous message for the biopharma industry as it reels from passage of dramatic pricing legislation earlier this year.

Pricing Debate Medicare

‘The Pandemic Is Over’? Not For US FDA

President Biden’s informal declaration that the COVID-19 pandemic is ‘over’ likely portends a formal end of the Public Health Emergency. But many of the US FDA’s COVID flexibilities don’t directly depend on that decision.

Coronavirus COVID-19 Review Pathway

US FDA Role In Biomanufacturing Initiative Largely Packages Ongoing Works

The White House ‘Biotechnology’ initiative is very broadly focused, with non-health sectors receiving the bulk of the attention. The US FDA’s role is small – but it could further boost attention to efforts to encourage adoption of advanced manufacturing.

Manufacturing Research & Development

President Bio-den? Executive Order Highlights Value Of Biotech – But Doesn’t Change Pricing Message

The White House is playing up a new initiative to support ‘biotechnology and biomanufacturing.’ The focus on innovation is always a welcome theme – but it does not signal any change in the emphasis on cutting drug pricing in the Biden Administration.

Manufacturing Research & Development

Accelerated Approval In The US: It Really Is Rare Outside Of Oncology

Everyone knows that cancer drugs dominate use of the Accelerated Approval pathway by the US FDA. But it is remarkable just how rare a non-cancer AA is.

Review Pathway Approvals

US Price Negotiation Process: Is Case-By-Case Politically Sustainable?

Republican Congressional letter asking HHS nuts-and-bolts questions about the newly enacted drug price ‘negotiation’ law points to a much more fundamental issue: can a bureaucratic agency make the program work in a manner that appears credible and free of undue political interference?

Pricing Debate Medicare
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