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An open-sourcing mandate, a new Readout Loud episode, & Novartis spins off Sandoz

 

The Readout

Meghana today! We have a controversial directive from the White House to open-source government-funded research, see what FDA chief Robert Califf prioritizes in terms of biomedical innovation, and more. 

Novartis spinning off Sandoz

Novartis plans to spin off its generics arm, Sandoz, by next year in order to focus more intently on its branded and patented prescription drugs. Once it hits the public markets as an independent entity, Sandoz will be Europe’s largest maker of generics and biosimilars, Bloomberg writes.

Sandoz accounts for nearly a fifth of Novartis’ $52.9 billion in revenue, but it’s still considered one of the company’s less lucrative units. When the pandemic — and resulting social distancing — decreased demand for generics and over-the-counter medicines, Sandoz’s growth lagged.

“We believe this decision is in the best interests of our shareholders,” and creates a “new Novartis,” CEO Vas Narasimhan said — adding that it will “conclude Novartis’s journey to become a focused innovative medicines company.”

A new directive to open source government-funded research

The White House has mandated that health and science agencies make federally funded studies available immediately to the public after they are published. Advocates for open access research have pressed for this sort of transparency for years, but the directive threatens to destabilize the business models of scientific journals.

The guidance from President Biden’s Office of Science and Technology Policy is “a transformational document,” one open data proponent told STAT's Sarah Owermohle. “This is going to change how it is that science is communicated, and what the public and particularly other researchers have access to in the work that was done.”

Not everyone is a supporter of opening up access to published research. Some say the policy could cost the government more money because it’d have to underwrite increased fees for researchers looking to publish their studies — and could cause some publishers to shutter, thanks to the resulting decrease in revenue.

Read more.

Are we getting Covid-19 boosters wrong?

Which venture capitalists are missing their marks? And what’s Anthony Fauci’s legacy? We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast.

Our colleague Helen Branswell joins to explain the Covid-19 booster debate, the Biden Administration’s monkeypox response, and the long career of the soon-to-step-down Anthony Fauci. We also discuss the latest news in the life sciences, including a milestone for gene therapy, the tentative return of an IPO market, and the venture capital league table.

Listen here.

Califf asks biopharma to focus on addiction, chronic disease

FDA Commissioner Robert Califf believes the biopharma community needs to “review its priorities” and shift its focus to chronic disease and addiction. Although there’s been a lot of progress in treating cancer and rare diseases — and lots of money made —  Califf points out in a Science op-ed this week that issues like cardiometabolic disease and opioid overdoses are driving steeper declines in U.S. life expectancy. So biopharma ought to deliver new therapeutics in these areas, he writes, “particularly for those suffering most: racial and ethnic minorities, people with less education and wealth, and those living in rural areas.”

Califf also said that the FDA will heed lessons learned during the Covid-19 pandemic and apply them to other areas of biomedical research. This will involve “reinventing research translation across biomedical sectors,” he writes.

More reads

  • WHO reports 21% decline in monkeypox cases globally, Reuters
  • Mouse embyros grown without eggs or sperm: why and what’s next? Nature

Thanks for reading! Until next week,

@megkesh
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Friday, August 26, 2022

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