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Good morning. I’m each excited and terrified to report that it’s Might! Time flies after we’ve acquired a number of information.
The necessity-to-know this morning
- Madrigal Prescription drugs reported $137.3 million in first-quarter gross sales for its MASH drug Rezdiffra, topping consensus analyst estimates. It’s been an excellent week for biotech drug launches, with BridgeBio and Verona additionally posting sturdy outcomes.
- Biogen reported first-quarter earnings, together with better-than-expected $96 million in gross sales of Leqembi, its Alzheimer’s remedy co-marketed with Eisai.
- Much more earnings reviews from Blueprint Medicines, Alkermes, and Alnylam Pharma.
Eli Lilly falls as Novo secures main insurance coverage win
Shares of Eli Lilly dropped in pre-market buying and selling this morning, as competitor Novo Nordisk secured a serious win on insurance coverage protection and as Lilly reported first-quarter earnings that fell wanting buyers’ expectations.
CVS Caremark, the biggest pharmacy profit supervisor within the U.S., introduced right this moment that beginning in July, Novo’s weight reduction remedy Wegovy would be the most well-liked GLP-1 drugs on its largest industrial formularies, seemingly making Wegovy extra accessible to sufferers than Lilly’s weight reduction remedy Zepbound.
Additionally this morning, Lilly reported gross sales of Zepbound and the sister diabetes drug Mounjaro that have been roughly in keeping with analysts’ estimates. Buyers, although, have been hoping for higher numbers, mentioned Mizuho analyst Jared Holz.
Moderna makes extra spending cuts, updates vaccine plans
From STAT’s Jason Mast: Moderna mentioned this morning in its earnings report it deliberate to chop prices by round $1.5 billion by 2027, including $700 million to $1 billion on prime of extra modest cuts introduced final 12 months.
The corporate has continued to face long-standing questions from its buyers about its post-pandemic enterprise, together with new issues about what vaccine-skeptical management at HHS might imply for a biotech constructed round mRNA.
Moderna additionally mentioned it now not anticipated to obtain approval for its mixture Covid/flu vaccine shot in older adults this 12 months, noting that the FDA has confirmed it must submit efficacy information exhibiting the shot reduces flu circumstances first. And it mentioned it was “deprioritizing” creating the mix shot for youthful adults.
It’s not clear if these strikes are tied to the information that FDA political appointees have concerned themselves in vaccine choices. Moderna had already mentioned in February it could want flu efficacy information from an ongoing trial earlier than getting approval in older adults. In the meantime, the industrial marketplace for Covid vaccines amongst youthful adults has collapsed and management was trying to find methods to chop prices.
Key GOP senators oppose Trump’s analysis cuts
At a listening to yesterday, senators from each side of the aisle rebuked the Trump administration over cuts to federally funded biomedical analysis. The critics included GOP Sen. Susan Collins, chair of the Appropriations Committee that funds the federal government, making her one a lot of the highly effective Republicans to talk out towards the cuts.
Collins singled out the administration’s effort to cap funding for oblique analysis prices at universities, saying that the plan violates the regulation. “These one-size-fits-all caps will likely be extraordinarily dangerous to many establishments,” she mentioned.
Trump administration officers didn’t testify yesterday, however Collins mentioned she plans to carry one other listening to on this matter at which administration witnesses will seem.
Learn extra from STAT’s John Wilkerson.
NIH to cut back animal testing, following FDA
The NIH mentioned it will cut back its reliance on animals in federally funded analysis and create a brand new workplace to develop the usage of “non-animal approaches.”
The transfer follows the FDA’s announcement final month to section out necessities for drugmakers to carry out animal testing, with the goal of decreasing R&D prices and, finally, the costs for prescribed drugs.
Just like the FDA, the NIH will flip towards AI and real-world information to mannequin illnesses and predict how medication might carry out. The NIH may even require grant evaluation workers to take part in coaching to deal with “potential bias in the direction of animal research” and publicly report annual analysis spending to measure funding for animal research.
Learn extra from STAT’s Ed Silverman.
Extra reads
