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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

Adu-CAN-umab? Reading The Tea Leaves For Biogen’s US Filing For Alzheimer’s Drug

The US Food and Drug Administration is expediting the review for Biogen’s Alzheimer’s therapy aducanumab, setting up a likely November/December advisory committee consideration that in normal times would be the dominant topic for those who care about the agency.

Advisory Committees Drug Review

340B And US Drug Pricing: Trump’s First Target Is One That Lasts

The US government program that allows safety net providers to purchase drugs at deep discounts is probably not what most American voters have in mind when they say drug pricing is a top issue. But the 340B program has been a rare area of consistent focus – and actual sustained change – in the Trump Administration.

Medicare Pricing Debate

Virtual Advisory Committees Are Here, And They Will Take Some Getting Used To

The first virtual US FDA advisory committee review of a drug application was nearly a disaster, but the second proved that the concept can work. Nevertheless, things are going to be very different for sponsors, even when the technology is perfected.

Advisory Committees Drug Review

Biden-Sanders ‘Unity Platform’: Moderate On Coverage, Extreme On Drug Pricing

The US Democratic Party will not be rallying around ‘Medicare for All’ in November. But the absence of a push for a single payer system is about the only good news for drug companies in the ‘unity platform’ released by presumptive Presidential nominee Joe Biden and his defeated rival Bernie Sanders.

Elections Politics

Global Supply Chain Security Meets US Presidential Politics

Joe Biden’s presidential campaign now has a plan to address supply chains and encourage US-based manufacturing of prescription drugs. That affirms the unlikely national prominence of the issue – and reduces the chances of meaningful legislation this year.

Manufacturing Politics

Shared Control: Novel Trial Design Works In COVID, But Will Sponsors Buy In?

COVID-19 has helped demonstrate the viability of platform trials with a shared control arm. That model is easier to extol than it is for sponsors to embrace, especially outside of crisis mode.

Clinical Trials Research & Development
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