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The Readout Damian Garde & Meghana Keshavan

How the FDA came to that polarizing Aduhelm decision

Over the course of three momentous meetings this spring, FDA officials set out the path by which Aduhelm, the subject of a stinging review from outside advisers, would win an unprecedented accelerated approval in Alzheimer’s disease.

According to a trove of documents made public yesterday, the FDA spent months debating the merits of Biogen’s Alzheimer’s drug. To one contingent, Biogen’s data — culled from two clinical trials, one positive, the other negative — were too messy to support the notion that Aduhelm delayed the progression of Alzheimer’s. To another, the evidence, combined with a desperate desire for new treatments, was enough to justify approving the drug. In a pivotal, cross-agency meeting on April 26, the FDA finalized a third path: approving Aduhelm based on its ability to clear toxic plaques from the brain rather than on its effects on Alzheimer’s progression.

FDA officials defended the agency’s decision in an interview with STAT on Tuesday. Patrizia Cavazzoni, director of the FDA’s drug division, said the agency is “on very solid ground,” and Peter Stein, director of the FDA’s Office of New Drugs, said using accelerated approval for Aduhelm “was not us trying to fit a round peg into a square hole.” 

Read more.

A biopharma gadfly is joining the industry

Peter Bach, the academic who built a career making incisive critiques of how the drug industry prices its products, is leaving his post at Memorial Sloan Kettering to join a liquid biopsy startup.

As STAT’s Matthew Herper reports, Bach will be the chief medical officer at Delfi Diagnostics, a Baltimore firm that raised $100 million in venture funding this year to develop tests that can detect fragments of cancer DNA in the bloodstream.

He leaves behind an influential post at Memorial Sloan Kettering’s Center for Health Policy and Outcomes, where he became a proud industry irritant and a widely cited counterpoint to pharma's insistence that expensive medicines translate to better science. But Bach is an oncologist by training, and joining Delfi is a chance to return to the work that brought him into medicine in the first place, he said.

Read more.

The Senate’s loudest voice on drug pricing has a soft spot for biotech

Sen. Ron Wyden, typically a fierce critic of the drug industry, has promised that his signature drug pricing legislation would spare small biotech companies, a surprising concession that might finally get the package to President Biden’s desk.

As STAT’s Nicholas Florko reports, Wyden, an Oregon Democrat, name-checked biotech startups that are developing “groundbreaking new treatments” and promised his legislation “can be tailored to the scale of these companies, as well as other factors that affect their access to capital.” 

Wyden didn’t specify just how emerging drug developers would be protected, but the very fact that he’s open to the idea will be a relief for small biotech firms, which have claimed that sweeping reforms to drug pricing would constrain their investments in research. 

Read more.

It’s a pivotal day for GSK

GlaxoSmithKline, beset by declining revenue and a few unhappy shareholders, will make the case for its vision of the future today, trying to win the hearts and minds of investors.

In a webcast slated to last more than three hours, CEO Emma Walmsley will unveil what the company is calling “New GSK,” joined by head scientist Hal Barron and other executives to talk about refreshing the pipeline and returning the company to growth. 

Where it might get interesting is in the hour allotted for Q&A. Activist investor Elliott Management has taken a multibillion-dollar stake in GSK and has been agitating for other shareholders to get on board with its plans for sweeping changes at the company, which could include deposing Walmsley and breaking up the business. With Elliott operating in the background, today’s event takes on added meaning.

More reads

  • Key science officials detail their plans for a new research agency — and Congress is getting closer to funding it. (STAT+)
  • Woodcock defends Biogen's new Alzheimer's drug, says it has more supportive data than many past accelerated approvals. (Endpoints)
  • Study testing Moderna vaccine in transmission prevention to include young adults. (Reuters)
  • How the pandemic has reshaped collaboration — and competition — in science. (STAT)

Thanks for reading! Until tomorrow,

Wednesday, June 23, 2021

STAT

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