Scrip is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

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

Moderna And The All-American Drug Pricing Hearing

Moderna’s time in the hot seat of the US drug pricing debate went about as well as it could for the company. The firm astutely set a tone of an All-American success story – but the hearing also showcased other ‘only in America’ themes.

Vaccines Pricing Debate

Xtandi Still Faces Likely US Price Cut Even As It Avoids ‘March In’ Proceeding

The Biden administration decision not to pursue ‘march in’ proceedings for Pfizer/Astellas’ Xtandi sounds like good news. The reality is that the prostate cancer therapy is likely to face a more certain federal pricing intervention in the first year of the new Medicare ‘negotiation’ process.

Reimbursement Medicare

A Milestone Moment For Pharmacogenomics: US FDA Ready To Drop ‘Voluntary’ Program

The US FDA’s plan to update a 20-year-old guidance on pharmacogenomic data submissions is a good time to reflect on the dramatic transformation of industry attitudes and approaches to targeted medicine over the past two decades.

Guidance Documents Personalized Medicine

Single Product, Single Price: Medicare Will Include All Versions Of Active Ingredient For Negotiation

The US Medicare agency intends to treat all dosage forms of the same active ingredient as a single drug for purposes of its new price negotiation authority. The approach will have implications for product branding and line extension strategies.

Reimbursement Medicare

QALY Control: House Bill Would Ban Cost-Effectiveness Tool In US Programs

No one seems eager to defend the QALY tool as a House Republican bill seeks to prohibit any federal agency from using Quality Adjusted Life Years as a formula to determine pricing.

Pricing Debate Reimbursement

The ODAC Losing Streak Ends

US FDA’s Oncologic Drugs Advisory Committee’s endorsement of a first-line indication for Genentech’s Polivy is the first time the panel has voted ‘yes’ on a cancer drug application in almost three years.

Advisory Committees Drug Review
See All
UsernamePublicRestriction

Register