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.
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.
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.
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.
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.
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.