July 30, 2024

The need-to-know this morning

Pfizer earnings are here, Merck earnings are here. Keytruda sales were $7.3 billion, or 45% of Merck's total revenue for the second quarter.
BioNTech and Regeneron Pharmaceuticals reported results from a mid-stage study of their mRNA-based immunotherapy for melanoma.
Day One Pharmaceuticals reported $8.2 million in second-quarter sales for Ojemda, a treatment for a type of pediatric brain tumor approved three months ago. The company also raised $175 million through a PIPE with a group of existing shareholders and new investors.

alzheimer's

A GLP-1 drug may help protect the brain

A new study out this morning suggests that an older GLP-1 drug called liraglutide may help protect the brains of people with early Alzheimer's disease.

The Phase 2 trial found that compared with the placebo group, treated patients had nearly 50% less shrinking in parts of the brain that control memory and learning and a slightly slower decline in cognitive function. It's an early study, though, and more research will be needed to see if GLP-1 drugs can actually help treat Alzheimer's.

Novo Nordisk is currently running two Phase 3 trials testing the oral version of semaglutide (the active ingredient in Ozempic/Wegovy) in Alzheimer's.

policy

Has Medicare gotten a good deal on drug prices?

We're coming up on Sept.1 , the deadline for Medicare to announce the drug prices it negotiated this year, the first year it was able to negotiate prices under the Inflation Reduction Act. This could be a win for Democrats to tout on the campaign trail, but how can we tell if the Biden administration actually got a good deal?

My colleague John Wilkerson brings in experts to walk us through the different factors to consider, including whether the negotiated prices actually save taxpayers money, whether they save Medicare beneficiaries money, whether they represent the value of the medication, and how they compare to prices abroad.

liquid biopsy

Guardant's blood test still faces hurdles after approval

Yesterday, the FDA approved Guardant Health's blood test for colon cancer, called Shield. The FDA label includes broader claims than what some observers expected, as it says that the test can be used as a first-line option. In all, it's a big step for the field of liquid biopsy, but Shield still has to clear more hurdles before gaining widespread adoption.

CMS will need to agree to cover the test, and usage could also depend on whether the U.S. Preventive Services Task Force recommends the test and for whom. Leerink analysts predict that Shield will be a third choice among doctors after colonoscopy and a stool-based test.

pharma

Sanofi CEO calls on the EU to prioritize AI

Europe is facing "a competitiveness crisis," Sanofi CEO Paul Hudson writes in a new opinion piece for STAT. Twenty-five years ago, one in two drugs was invented or discovered in labs in Europe, he says, while today, it's one in six. Hudson thinks the way the EU can fix that and help the biopharma sector is to support the development of AI technologies.

He calls on the EU to design frameworks for ethical AI systems in health care settings and to coordinate data sharing in a protected cloud. He also thinks the EU should reform education in a way that prioritizes data science and AI literacy.