Pink Sheet is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

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.
Advertisement
Set Alert for Articles By Michael McCaughan

Latest From Michael McCaughan

Learning To Love The “CFL”: US FDA’s New Communication Policy

Final guidance on communication “consistent with the label” is noteworthy for how closely it follows Obama-era draft. That may be a surprising twist given the background of the Trump-era FDA Commissioner and HHS Secretary – but on balance is probably the best possible approach for maintaining the current FDA approval climate.
Advertising, Marketing & Sales Legal Issues

Pacira’s Exparel Will Get Separate Medicare Payment; CMS Still Wants Better Opioid-Sparing Data

US Centers for Medicare and Medicaid Services proposes a change to its reimbursement policies for non-opioid pain therapies which will benefit a single product: Pacira’s Exparel. However, the broader message for that company is mixed.

Reimbursement Medicare

Pointing Fingers On Biosimilars: FDA Versus FTC

US FDA is talking tough on antitrust enforcement. But is there any reason to think FTC is listening?
Biosimilars Legal Issues

Part B Reform: HHS Proposal Is Intriguing – But Bigger Message Is Timing

“Immediate” actions on drug pricing reform aren’t necessarily happening soon, given that the competitive bidding proposal is just a request for information.
Pricing Debate Reimbursement

Importation To Address Drug Pricing? Just Do It – But Don’t Justify It

The idea of permitting importation of competitors to products like Daraprim has an undeniable appeal, and – unlike essentially every other idea on the table to deal with drug pricing – would actually address the singular example that helped kick off the current debate. But creating a legal framework to justify the action is very perilous for the industry overall. 
Pricing Debate Policy

GSK Wins First-Ever Voucher Race With Anti-Malarial Approval

US FDA’s approval of tafenoquine for malaria settled a first-of-its-kind race: GSK beat 60 Degrees to market to claim a priority review voucher.
Review Pathway Rare Diseases
See All
Advertisement
UsernamePublicRestriction

Register