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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

A Complete Retreat: “Protected Classes” Stay Protected In US Medicare

CMS has abandoned its plan to give private plans more leverage in the “protected” drug classes in Part D. It will probably be a long time before anyone tries to change the protected classes again.

Medicare Reimbursement

The More Things Change: Gene Therapy Reopens Orphan Drug 'Sameness' Debate

Rare Diseases Gene Therapy

Insulin Biosimilars: US FDA Hears Wide Range Of Views From Small Set Of Sponsors

US FDA heard a predictably wide range of advice on the appropriate standards for approving biosimilar and interchangeable insulin during a public hearing on the topic. What is surprising is how few sponsors decided to speak out.

Biosimilars Metabolic Disorders

“Nobody Was Armed At NCI”: US FDA Head Sharpless Adjusts To Life As Regulator

Acting commissioner is entering the usual learning curve for new leaders of the agency. It’s a reminder of how unusual it was to skip that step under his predecessor.

 

FDA Leadership

Ain’t That A Sham: US House Bill Tries To Thread The Needle On Citizen Petitions

For years, brand industry critics have decried the use of “sham” citizen petitions to delay generic drug approvals. But one person’s “sham” is another person’s First Amendment right to petition the government. A House bill tries to thread that needle.

 

Generic Drugs Intellectual Property

Capping Off The Rebate Debate: Will 2019 Price Push End With Co-Pay Cap?

The pharmaceutical industry and its strongest critics have long agreed on one thing: Medicare Part D would be improved if there was a cap on spending by beneficiaries. Now, there is an unlikely path that may make it surprisingly easy to get it done.
Pricing Debate Legislation
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