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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 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

Drug Pricing Debate Will Carry Over To 2020

An eventful year for sweeping drug pricing legislative proposals in the US will end with enactment of a long-standing carryover proposal – new procedures intended to address perceived abuses of the REMS process – but nothing more substantial for the drug industry.

Pricing Debate Legislation

US FDA’s Narrow Path For Imports: Beware The 'SIP'-pery Slope

Newly proposed pathway to allow states to pursue wholesale importation of drugs from Canada is extremely narrow and restrictive, at least in draft form. It is still a terrible precedent for industry – one that can be easily expanded if it takes effect.

Pricing Debate FDA
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