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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 Tale Of Two DMD Drugs: Theme And Variation In Controversial US FDA Reviews

Despite obvious similarities in the contentious reviews of Sarepta’s Vyondys 53 and its predecessor Exondys 51, drug developers should focus on the differences between the two reviews.

Rare Diseases Approvals

US FDA ‘Public Health’ Approach To Opioids May Open Up Pricing Debates

Latest effort by FDA to re-set reviews for novel opioid analgesics is off to a rocky start after three advisory committee reviews. One unintended consequences may already be apparent: by taking a broad, public health perspective on new formulations, the agency may be inviting arguments based on price.

Neurology Pricing Debate

The Failure Of Biosimilars In The US: ‘Headline’ News

A Washington Post article on price hikes for Abbvie’s Humira highlights patent ‘thickets’ and anti-biosimilar strategies. But the lack of understanding of the basic concepts of the biosimilar system are a much bigger warning sign about the viability of the pathway.

Biosimilars Pricing Debate

US FDA’s Breakneck Approval Pace Clashes With Advisory Committee Mandate

FDA has approved more than 100 novel molecules in the past two years, almost all of them without an advisory committee stop. Is it time to revisit a 2007 law that was intended to assure a public vetting of NMEs prior to approval?

Advisory Committees Drug Review

Bladder Pain Syndrome: US FDA Outlines A Different Approach To Personalized Medicine

US FDA is following through on defining interstitial cystitis and bladder pain syndrome as a single condition – a move that runs counter to the trend towards more targeted, mechanistic definitions of disease. But the agency also offers a unique idea for endpoints that are truly personalized.

Cancer Guidance Documents

US FDA Dives Back Into Opioid Reviews Under New Division Leadership

Four new pain drug formulations are heading to advisory committees in January. The meetings will also feature new FDA leadership in the pain/addiction review division following the retirement of Sharon Hertz.

Advisory Committees Neurology
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