| | | |   | Good morning, all. Damian here with a look at a Washington powerhouse in decline, new hope for a once-promising idea in oncology, and a preview of some all-important Alzheimer's disease data. | | | Is PhRMA losing its edge? For years, the lobbying group PhRMA has waged war over even the tiniest policy changes that might impact the drug industry, flexing its enviable budget and ample influence to thwart legislative threats. But in 2022, as Democrats pushed forward with a bill that would let Medicare negotiate certain drug prices, PhRMA couldn’t muster the money or the clout to stop them. What happened?
As STAT’s Rachel Cohrs reports, the group’s aura of invincibility has been punctured over the past year, both by the passage of that pricing negotiation bill and by PhRMA’s muted rhetoric in its aftermath.
Despite PhRMA’s dire warnings that Medicare negotiation was an existential threat to the pharmaceutical industry, the group only increased its lobbying spending by about 2%. That’s a stark contrast to 2007, when PhRMA increased its spending by 25% after House Speaker Nancy Pelosi first introduced a bill that would have allowed the federal government to directly bargain with drugmakers, and the even bigger 29% boost it poured into its lobbying operations in 2009, ahead of the debate over the Affordable Care Act.
Read more. | Gilead declares a vague victory Researchers have spent roughly a decade trying to find novel cancer treatments that might boost the effects of blockbuster immunotherapies like Keytruda, which has largely been a process of finding new biological targets that go from promising to piddling after rigorous study. Among the latest is TIGIT, a target whose potential took a blow earlier this year when two clinical trials from Roche ended in failure.
But Gilead Sciences, which licensed a TIGIT-targeting medicine from Arcus Biosciences, has kept the faith. Yesterday, Gilead said an interim analysis of an ongoing trial had turned up positive results, with combinations of its TIGIT drug showing “clinically meaningful differentiation” compared to a standard immunotherapy on its own.
Absent from that press release were any data, which Gilead promised to present at a medical meeting next month. That leaves ample room for skepticism, both about Gilead’s treatment and about whether TIGIT is doomed to be the next disappointment in oncology’s search for a winning combination treatment. | We’re working to make health care more affordable and equitable. In every ZIP code. A ZIP code is more than a number—it’s a main street, a tight-knit community, a family home. And until every baby goes home with a healthy parent. Until patients and caregivers speak the same language. Until routine care becomes routine, for everyone. Blue Cross and Blue Shield companies will work to make health care more affordable and equitable for everyone, for the health of America. Learn more. | An all-important Alzheimer’s conference The first surprise was a pleasant one. Lecanemab, an Alzheimer’s disease treatment from Eisai and Biogen, succeeded in a pivotal trial, reversing decades of disappointment. Then, two months later, a similar treatment from Roche failed in two studies of its own. Is lecanemab simply a better drug, or did Eisai set success in motion by designing a smarter trial?
We’ll get some answers this week at the Clinical Trials in Alzheimer’s Disease conference, starting today in San Francisco. Tonight, Eisai will present detailed data from lecanemab’s Phase 3 trial. On Wednesday, Roche will dig into the failure of its treatment, called gantenerumab.
The two presentations present a rare opportunity for a field accustomed to dissecting disappointing studies. Eisai’s data, if they hold up, could present a replicable model for future Alzheimer’s studies. And Roche’s failure, depending on the details, could close the door on a few ideas that once seemed promising. | Axsome’s depression drug succeeded in an Alzheimer’s study Axsome Therapeutics’ approved treatment for depression significantly reduced the rates of agitation among patients with Alzheimer’s disease in a small clinical trial, an unexpected success in a study Wall Street had largely written off.
As STAT’s Allison DeAngelis reports, the drug met its primary goal of delaying and preventing patients from relapsing into agitation. Patients taking the drug had a 3.6-fold lower risk of relapse overall, compared to placebo.
Axsome had ended the study early in order to launch a larger trial in a similar patient population, a decision that reduced its statistical power and led analysts to assume it would end in failure. Now there’s a chance Axsome could seek FDA approval without waiting on that larger trial, news that sent the company’s stock price up more than 30% yesterday.
Read more. | More reads - ‘Skinny labels’ on biosimilar medicines saved Medicare $1.5 billion over a recent five-year period, STAT
- World’s top-selling drug going off patent means big bucks for middlemen, Wall Street Journal
- mRNA startup Strand Therapeutics raises millions to test targeted cancer therapies, Boston Globe
| Thanks for reading! Until tomorrow,  | | | |
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