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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

The Power Of The Open Public Hearing

The US FDA took three high profile applications to an external advisory committee meeting during the week of 8 May – and offered a very skeptical read on the approvability of each. All three won positive votes from the committees, in no small part thanks to the messages delivered during the Open Public Hearings.

Advisory Committees Drug Review

US Medicare Agency Clarifies View Of Accelerated Approval

CMS says it has not changed its historical policy towards drugs granted Accelerated Approval. The agency does, however, appear to be suggesting grounds for skepticism towards novel uses of the regulatory pathway.

Medicare Reimbursement

When History Has Its Eyes On You: Opill Vote Puts US FDA In Tough Spot

A unanimous US FDA advisory committee vote in favor of a landmark decision to make oral contraceptives available without a prescription should be history in the making. But the desire to make history – rather than address FDA’s significant concerns with the actual application for Perrigo’s Opill – seems to have carried the day.

Advisory Committees Women's Health

When History Has Its Eyes On You: Opill Vote Puts US FDA In Tough Spot

A unanimous US FDA advisory committee vote in favor of a landmark decision to make oral contraceptives available without a prescription should be history in the making. But the desire to make history – rather than address FDA’s significant concerns with the actual application for Perrigo’s Opill – seems to have carried the day.

Advisory Committees Women's Health

Leqembi Coverage Expansion: US Medicare Head Promises Light Touch On Registry

Medicare is not envisioning an overly burdensome process to fulfill its requirement for a registry as a condition for coverage of ‘fully’ approved beta amyloid Alzheimer’s therapies, the head of the agency tells Congress. Biogen and Eisai still hope to have the registry obligation removed altogether.

Reimbursement Medicare

COVID Vaccine Transition Planning: Price Does Not Come Up At ACIP

US CDC is starting to prepare for the transition of COVID vaccine deliver to more traditional commercial channels. It is noteworthy that the first discussion of what will change did not include any talk of prices.

Vaccines Reimbursement
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