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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 Big Week For FDA’s Top Eye Drug Reviewer

Ophthalmology supervisory medical officer Wiley Chambers played a key role at three different advisory committee meetings in early October. Only one was a review in his division.

Advisory Committees Drug Review

Antibiotic Incentives: Prize Fund Is Focus Of Presidential Report On Incentives

Upcoming White House report on antibiotic incentives will provide a strong endorsement of one-time payments to reward successful development of new therapeutics. That is a mixed blessing for advocates for legislative action for incentives who are focusing on 'wildcard' patents.

Infectious Diseases Intellectual Property

Opioid Abuse: The Limits Of Industry’s Response

PhRMA is endorsing dispensing limits on opioids and pledging to support a public/private partnership to develop new treatments and alternatives. But members of a Presidential Commission didn’t seem impressed.

Advertising, Marketing & Sales Policy

Opioids And Psychic Pain: Alkermes Uses High-Profile Stage To Highlight Depression Drug

Biopharma companies working on non-addictive pain drugs and new therapies to treat addiction had a high-profile platform during the most recent meeting of the President’s Commission on opioid abuse. Alkermes made the most of the opportunity.

Drug Approval Standards Neurology

FDA’s DMD Decisions: Glass Two-Thirds Full?

The outcome of an US advisory committee review of PTC’s ataluren was not surprising. That is bad news for PTC’s prospects of launching the drug in the near term – but given the recent history of the DMD class, it is probably good news for biopharma companies overall as a sign that FDA's neurology group is moving forward effectively.

Advisory Committees Drug Approval Standards

Mechanism-Based Drug Rejection? Ataluren’s Unlikely Personalized Medicine Milestone

US FDA has shown it can be very flexible in expanding indications for a targeted therapy with a clearly established mechanism of action. But, as PTC Therapeutics learned, the agency’s willingness to apply mechanistic knowledge for targeted therapies cuts both ways.

Rare Diseases Drug Approval Standards
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