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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

The Sarepta Precedent: The Good, The Bad, And The Ugly

Podcast discussion of three broader precedents stemming from US FDA's original Exondys 51 approval.

Drug Approval Standards FDA

Praluent’s Price Cut: Testing The Tech Model For Drug Pricing

It may be more accident than design, but Sanofi and Regeneron are applying a tried and true pricing model to Praluent. Just ask tech companies. 
Pricing Strategies Cardiovascular

The Eteplirsen Precedent: No Denying It – So Let’s Define It

US FDA allowing Sarepta to seek accelerated approval for follow-on DMD agent – following 'precedent' set by eteplirsen. Now the new challenge is to define exactly what that precedent is.

Drug Approval Standards Drug Review

When Lobbying Turns: Lessons From The Gun Control Debate For Pharma

The sudden shift in the politics of gun control is the latest example of how a long record of lobbying success can turn quickly. 
Pricing Debate Legislation

The Zinbryta Withdrawal And The Limits Of US FDA’s Proactive Communication

FDA is getting justifiably high marks for its efforts to accelerate drug development, and the proactive communication approach of Commissioner Gottlieb is a big part of that dynamic. But a drug safety withdrawal could be a sign of trouble ahead, if the perception takes hold that Europe is more proactive when it comes to patient safety.

Drug Safety Neurology

PTC’s Ataluren and Accelerated Approval: Is Eteplirsen A Precedent After All?

US FDA appears willing to consider accelerated approval for PTC's Duchenne Muscular Dystrophy therapy ataluren if company is able to provide compelling evidence of increased levels of dystrophin in boys with nonsense-mutation DMD. That is quite a reversal from the agency’s view heading into PTC’s appeal. 
Drug Approval Standards Rare Diseases
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