Replimune finally wins battle for FDA approval

After two rejections and an extraordinary third review, the FDA has granted accelerated approval to Replimune's melanoma therapy RP1 — a decision that suggests regulators are applying a more flexible approach to cancer drug reviews, despite lingering concerns from FDA staff about the underlying data. The list price of the drug, Tudriqev, will be $450,000 per course of therapy before rebates and discounts.

“We expect strong demand for the regimen given its relative ease of access and benign safety profile,” said Leerink biotech analyst Daina Graybosch in a research note last week.

Despite concerns from former FDA oncology chief Richard Pazdur during the approval bid last year, the agency's advisers ultimately concluded that the treatment's apparent benefits for patients who have exhausted PD-1 inhibitors outweighed any flaws in the single-arm trial.

biotech hubs

Boston is giving up ground to SF

Boston keeps insisting it's the biotech capital of the world, and it still has a very good case to make. But it's also hard to ignore founders who were generated there but decided it’s time to leave.

Felix Wong grew up in Massachusetts, earned degrees from Harvard, trained at MIT, and still concluded Silicon Valley offered something Boston couldn't: investors willing to bet on ambitious young people before they had gray hair.

“There’s some crazy experiments that we’re currently running ... that I probably would not have thought about when I was in Boston,” Wong said.

His company, Integrated Biosciences, is just one startup, but it embodies a broader anxiety hanging over Massachusetts as AI reshapes biotech.

Read more from The Boston Globe's Emma Platoff.

alzheimer's

Tau's dark side points toward new treatments

Tau has long been considered one of Alzheimer's most important culprits, but Stanford researchers have now uncovered what may be one of the protein's most damaging tricks, a new Neuron paper shows. The protein seems to force electrons to run backward through mitochondria, triggering oxidative stress, inflammation, and neuronal injury, STAT’s Jonathan Wosen writes.

In mice, flies, and human neurons, blocking this reverse electron transport reduced neurodegeneration and improved memory — raising the possibility of an entirely new therapeutic strategy. The work’s inspired a startup, Cerepeut, to develop small molecule drugs aimed at stopping the process before neurons succumb.

drug pricing

Subtle Medicare policy shift could delay drug price negotiations

A subtle Trump administration policy change may have handed AbbVie years of additional pricing power, STAT’s Ed Silverman writes. A new analysis from Public Citizen argues CMS reset the clock for a narrow class of biologic drugs that were originally approved as traditional drugs before being reclassified.

This delayed the date by which AbbVie’s blockbuster pancreatic enzyme drug Creon might become eligible for Medicare price negotiations — pushing Creon's eligibility back seven years despite costing the federal program $1.5 billion yearly. The group contends the reinterpretation runs counter to Congress's intent, costs taxpayers money, and could ultimately benefit other companies — including Novo Nordisk and potentially Eli Lilly — if more drugs are later reclassified as biologics.