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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

Rx Spending Stands Out In CMS Projections – As Slowing Down

Pharmaceutical industry’s message on overall drug spending trends is getting some timely support from the Center for Medicare and Medicaid Services’ annual national health expenditure projections.

Pricing Debate Policy

Time For Big Pharma To Take Back Orphan Drugs

The controversy over Marathon’s pricing of the steroid deflazacort is fueling calls to revisit the US Orphan Drug Act. For Big Pharma companies, the threat should not be ignored. It is time for the industry’s biggest players to take back development of products like deflazacort to protect pricing for more innovative therapies.

Pricing Debate Policy

340B Freeze: 'Mega-Guidance' Withdrawn; Clarity On Program Boundaries Delayed Again

Long-delayed effort to define key boundaries for 340B drug discount program is on hold once again – and it may now take legislation to enable HRSA to move forward with plans to better define who is eligible for the discount.

Pricing Debate Legislation

Opana Safety Review Will Set Tone For Opioid Regulation Under Trump

FDA’s 2017 advisory committee calendar is extremely light, but the one product focused review on the schedule should be a doozy: a two-day look at safety issues with Endo’s Opana ER as well as generic versions of oxymorphone. The topic is likely to resonate with the Trump Administration and especially Vice President Pence.

FDA Advisory Committees

RAT Race Begins: FDA Accepting Regenerative Advanced Therapy Designation Requests

As part of a flurry of actions in the waning days of the Obama Administration, FDA formally announced a process for requesting the new “Regenerative Advanced Therapy” designation. Much like the early days of “Breakthrough,” the standards are uncertain for now.

FDA Review Pathway

Podcast: Silicon Valley's FDA

Perspectives on two individuals – James O’Neill and Balaji Srinivasan – under review for potential high-level posts at the US agency, plus lessons learned from how FDA topsiders have been selected in the past.

FDA Policy
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