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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

Aducanumab And The US Pricing Debate: A New Hook, But Still A Fuzzy Picture

Some Democratic senators are not fans of FDA’s approval of Biogen/Eisai’s Aduhelm, and are even more critical of the price of the Alzheimer’s therapy. That is providing a new hook to urge action on creating a federal price ‘negotiation’ program – but not any more clarity on a viable path to enacting one.

Pricing Debate Politics

US FDA Drug Center Director Cavazzoni’s Top Priority: Winning ‘Hearts And Minds’

Patrizia Cavazzoni, FDA Center for Drug Evaluation and Research director, knows she has ‘huge shoes’ to fill. Convincing the CDER staff that she is capable of doing so is job one.

US FDA Drug Center Director’s Top Priority: Winning ‘Hearts And Minds’

Patrizia Cavazzoni, the new director of the US FDA Center for Drug Evaluation & Research, knows that the has ‘huge shoes’ to fill. Convincing the CDER staff that she is capable of doing so is job one.

FDA Leadership

Better Late Than Never? US FDA’s Oddly Timed COVID Master Protocol Guidance

COVID has unequivocally shown the advantages of a ‘master protocol’ approach to providing definitive evidence about the benefits (or lack thereof) for repurposed therapies to treat a novel infection. Unfortunately, in the US, the proof has been in the failure of scores of separate studies to generate useful evidence. Can FDA change that before the next pandemic?

Clinical Trials Coronavirus COVID-19

AbbVie’s Stalling Tactics On Humira Pay Off – In More Ways Than One

A US House hearing focused on long-standing criticism of AbbVie for its ability to delay biosimilar competition for Humira. AbbVie was also able to delay the hearing, and that also seemed to work out well for the company.

Pricing Debate Biosimilars

The TRIPS Trap: Industry’s Delicate Challenge Responding To Waiver Push

Biopharma companies are understandably upset by the Biden Administration’s decision to support a waiver of intellectual property protections on COVID vaccines. But over-reacting may only make matters worse.

Intellectual Property Policy
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