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The Readout Damian Garde

Good morning! Adam Feuerstein here, the last fill-in for Damian. He’s back next week.  

Nocion gets hit with a $1 million lawsuit

Terrence Kelly thought he was the CEO of a Boston biotech startup. But he wasn’t, and now he’s suing. 

In his newly filed lawsuit, the pharma exec-turned-consultant says he was brought into Nocion to work up a budget and pitch deck that ultimately landed a $27 million Series A financing round. Kelly thought he was Nocion’s CEO, until he was shunted aside in favor of someone else, he alleges in the suit, which asks for $1 million and shares in the company. 

Nocion’s lawyers say Kelly’s accusations are without merit and the company will seek to have the lawsuit dismissed. Read more from STAT’s Kate Sheridan here

Pelosi’s drug-pricing plan is aggressive, but is it viable?

Can Moderna turn cells into tiny drug-making factories? What’s it like to cure your own rare disease? 

We discuss all that and more on the latest (Damian-less) episode of “The Readout LOUD,” STAT’s biotech podcast. First, STAT’s Lev Facher joins us to discuss the details of Pelosi’s “leaked” plan to curb sky-high prescription drug prices and whether Democrats and Republicans can find enough common ground to pass meaningful legislation. Then, we’ll break down the latest effort by the biotech unicorn Moderna to turn synthesized messenger RNA into drugs and vaccines. Finally, STAT’s Matt Herper grabs a mic to discuss his interview with a UPenn professor who nearly died five times from a rare disorder, but was saved each time by his own scientific ingenuity.

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.

It’s peanut allergy day at the FDA

Experts are gathering this morning at FDA’s White Oak campus to review a novel but controversial treatment from Aimmune Therapeutics that uses calibrated quantities of ingested peanut powder to protect people against severe peanut allergy. Aimmune’s “peanut immunotherapy” (brand name: Palforzia) is effective, but it’s not easy for people to tolerate and comes with some safety concerns, which is where the crux of today’s advisory panel debate is expected to focus. 

I will be watching a live feed of today’s advisory panel and posting updates to STAT throughout the day, including the penultimate vote on whether experts believe FDA should approve Palforzia, or not. You can read a preview of the Palforzia meeting here.

From peanuts to fish oil

While we’re on the subject of controversial FDA advisory panels, Amarin now has a firm date — Nov. 14 — for its own inquisition...er...I mean review of its fish oil-derived heart drug Vascepa. You’ll recall Amarin was telling investors as late as early August that an FDA advisory panel for Vascepa was unlikely. Then, FDA apparently changed its mind, causing much head-scratching and stock (Amarin’s) selling. 

FDA should really think about selling tickets to this one. 

More reads

  • Adverum cannot hide under an avalanche of concerns (Vantage)
  • Carcinogens have infiltrated the generic drug supply in the U.S. (Bloomberg Businessweek)
  • Vertex strikes a deal with Scotland for its cystic fibrosis medicines (STAT Plus)

Thanks for reading! Have a great weekend,

Damian

Friday, September 13, 2019

STAT

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