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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

US FDA Gene Therapy Staff-Up: Glass Three-Quarters Full?

Aggressive staffing goals for FDA’s gene and cell therapy review group might not be fully achieved – but the head of CBER believes the new organization is on track to deliver on his high expectations going forward.

Gene Therapy Leadership

The Real ‘Pill Penalty’: US Biosimilar Law, Not The IRA

Biopharma industry is making some modest headway in quest to change the new US Medicare drug price process to treat drugs and biologics on equal footing. But eliminating the so-called ‘pill penalty’ would not on its own equalize the incentives for small molecule and large molecule R&D.

Medicare Biologics

Medicare Price Negotiation Poses Challenges For Safety Net Providers

New drug pricing program under the Inflation Reduction Act could reduce the value of the 340B drug discount for safety net providers by as much as $1 billion in the first year, an analysis by the 340B Health association suggests.

340B Program At ‘Critical Inflection Point,’ Oversight Agency Head Tells Providers

The head of the federal agency overseeing the 340B drug discount program offers unusually direct calls for legislative action during the safety net provider association winter conference. But is action likely in Congress any time soon?

Pricing Debate Legislation

An Elegy For Aduhelm

Biogen’s decision to discontinue is Alzheimer’s treatment Aduhelm cements its status as one of the most spectacular commercial failures in biopharma history. But its impact on biopharma policy is still extraordinary.

Drug Approval Standards Post Market Regulation & Studies

Medication Therapy Management: The Gap Between Theory And Practice

US Medicare Payment Advisory Commission still sees promise in ‘Medication Therapy Management’ programs. But why is the value of enhanced pharmacy support for patients on complex prescription regimens so hard to prove in actual practice?

Medicare Reimbursement
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