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The Readout Damian Garde

Novartis is ‘exiting’ the people behind its data scandal


Novartis is “in the process of exiting” the employees responsible for falsifying data submitted to the FDA, CEO Vas Narasimhan said yesterday, employing an odd bit of language on a conference call with analysts.

That call, which wasn’t publicized beforehand, brought Narasimhan’s first public statement on the data manipulation scandal, which has thrust Novartis into an uncomfortable position. On Tuesday, the FDA revealed that Novartis waited three months to inform regulators about the issue, warning that there could be “civil or criminal penalties” for the company.

Narasimhan defended that decision, saying that “everyone in our organization can stand proud that we tried to do the right things in this instance."

Read more.

Trump’s international drug pricing plan is nearly upon us


One of President Trump’s long-promised — and, in pharma, long-feared — ideas on drug pricing will soon see the light of day.

As Bloomberg reports, Trump is planning to give a major speech next month in which he’ll outline a plan for an international pricing index, a system that would peg what Medicare pays for certain drugs to their prices overseas.

It’s an idea that could have vast implications on drug companies that rely on Medicare for sizable portions of their revenue. Industry share prices slumped earlier this year when Trump first brought up the notion but recovered last month when the Senate advanced a pricing bill that made no mention of an international index.

How Vor plans to outfox ‘every man and his dog’ in biotech


The early days of cancer cell therapy have long past, and now “every man and his dog are using T cells” to fight tumors, as longtime biotech executive Robert Ang put it.

Which is why Vor Biopharma, which Ang just joined as CEO, is taking a different approach. As STAT’s Kate Sheridan explains, Vor is taking a page from commonplace bone marrow transplants and adding a modern twist. The company’s approach involves editing out a certain protein in hopes of crafting a more effective cell therapy for blood cancer.

Vor’s technology, which Ang called “very elegant and very simple,” is still about 18 months away from a first clinical trial.

Read more.

How to pitch your health tech idea to a drug company


For the ever-growing list of startups trying to marry technology and health care, cozying up to a deep-pocketed drug maker can provide valuable validation and a little money to keep the doors open. But how do you make your case to the gatekeepers of biopharma?

Patrick Dey, the Amgen vice president who presides over digital health, gets a flood of emails — “I don’t know how many a day” — from companies claiming their technology can be of service, and his team proactively scouts for leads on potential partnerships.

The interesting ones make a short list that gets debated within Amgen, Dey told STAT’s Rebecca Robbins. Then begins a winnowing process that leaves most would-be partners out in the cold, with only the most promising companies invited to participate in a trial relationship.

Read more.

Medicare finally decided how to deal with CAR-T


After months of controversial deliberation, the federal agency that runs Medicare has issued rules on how it will pay for CAR-T cancer therapies.

As STAT's Nicholas Florko reports, the big takeaway is that Medicare will shell out for the costly treatment so long as hospitals comply with some FDA-mandated safety regulations, even if the CAR-T in question is used for cancers not covered by the official label.

That's important for hospitals, which have long complained that the lack of a Medicare directive has left them subsidizing the cost of CAR-T, which can reach beyond $400,000 for a single patient. Whether it matters to Gilead Sciences and Novartis, the two companies with approved CAR-T products, is another story.

Read more.

More reads

  • Biotech, but make it beauty: Startups look to viruses and bacteria for the next generation of skin care. (STAT)
  • Should you save your cells now to fight cancer later? (One Zero)
  • China’s path to AI domination has a problem: loss of talent to the U.S. (MIT Tech Review)
  • 23andMe had devastating news about my health. I wish it hadn’t come by email. (STAT)

Thanks for reading! Until tomorrow,

Megan

Thursday, August 8, 2019

STAT

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