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The Readout Damian Garde

Can Botox make Big Pharma attractive?


What qualifies as a “cabal”? And will the CRISPR patent fight outlive us all?

We discuss all that and more on the latest episode of “The Readout LOUD,” STAT’s biotech podcast. First, we pick apart the proposed merger of AbbVie and Allergan, a pharmaceutical marriage of convenience with vast implications for the drug business. Second, STAT’s Sharon Begley joins us to discuss her story on how scientific dogma thwarted new ideas in Alzheimer’s disease research. Then we dig into a curious bit of biotech marketing that left some key facts unstated. Finally, we embark on a lightning round, featuring CRISPR patents, Democratic candidates, and a pugilistic federal agency.

You can listen to the episode here. To listen to future episodes, be sure to sign up on iTunes, Stitcher, Spotify, or wherever you get your podcasts.

The tricky thing about FDA paraphrasing


Yesterday, the CEO of Ovid Therapeutics told the world that the FDA “agreed” with his company’s plans for a rare disease drug trial, clearing the way for a study that would support approval if it’s positive.

That’s good news for Ovid, which has struggled to engender investor confidence in its lead drug, a treatment for the rare and debilitating Angelman syndrome. But it also underlines a biotech truism: When the subject is interactions with the FDA, it’s always a one-sided conversation.

The FDA is prohibited from disclosing anything from closed-door meetings with companies developing drugs. That means any news about those meetings comes only from the companies themselves, and their characterizations don’t always jibe with the FDA’s eventual decisions.

There’s no reason to think the FDA hasn’t “agreed” with Ovid, as its CEO, Jeremy Levin said, but investors can be forgiven for calling to mind the cases of Trevena and Sarepta Therapeutics.

We knew he’d land on his feet eventually


Dr. Scott Gottlieb, who until April was the head of the FDA, will soon join the board of directors of Pfizer, a company that makes drugs regulated by the FDA.

The news is guaranteed to raise the hackles of the many advocates who considered Gottlieb’s FDA as overly conciliatory to the industry it policed. Gottlieb’s pre-FDA career included time spent investing in and advising drug companies, a corporate original sin for which the Public Citizens of the world never forgave him.

But it’s worth noting that Gottlieb is far from the first FDA commissioner to find post-agency employment in the drug industry. Drs. Margaret Hamburg and Andrew von Eschenbach are on the respective boards of Alnynlam Pharmaceuticals and Bausch Health. And Gottlieb’s predecessor, Dr. Robert Califf, joined Google biotech spinoff Verily Life Sciences within four months of leaving the FDA.

Draper is going from the vastness of space to the confines of a cell


The secretive Draper Laboratory is perhaps best known for its work on getting people to the moon or crafting futuristic implements of death. But the Cambridge, Mass.-based nonprofit has been quietly investing more and more of its efforts into an altogether different technology: biotechnology.

As STAT’s Kate Sheridan reports, Draper has partnered with seven drug companies, most recently Bristol-Myers Squibb, to develop technology that would make it easier to determine whether investigational drugs are toxic.

Much of the work has focused on organ-on-a-chip technologies, handheld machines meant to simulate human biology. The idea is to allow scientists to test how their drugs might affect a given organ without the need for animal or human trials.

Read more.

More reads

  • Making music from proteins to better understand biology. (STAT)
  • Microsoft is cashing in on the biggest biotech IPO of 2019. (CNBC)
  • Potential class action lawsuit accuses the University of Chicago of sharing identifiable patient data with Google. (STAT)

Thanks for reading! Until next week,

Megan

Friday, June 28, 2019

STAT

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