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The Readout Damian Garde & Meghana Keshavan

The latest edition of our STAT Plus Conversations series invites you to ask any question you might have for the hosts of "The Readout LOUD" podcast — Adam Feuerstein, Rebecca Robbins, and Damian Garde. The event starts 1 p.m. ET, and you can sign up here

The (possible) heir to an FDA powerbroker

If you made a list of people in biopharma recognizable by first name alone (perhaps you’re quite bored), No. 1 should probably be Janet Woodcock, the superlatively influential leader of the FDA’s drug division. Woodcock is an industry powerbroker, with a nearly mythic reputation and outsized personality. She’s also 71, which has left FDA experts urgently wondering who could possibly replace her.

As STAT’s Nicholas Florko reports, there appears to be an heir in waiting. Patrizia Cavazzoni, who joined the FDA just two years ago, has been running the FDA’s drug approval operation during Woodcock’s recent sabbatical to focus on coronavirus vaccines. And agency insiders say she’s being groomed to take over whenever Woodcock retires.

Cavazzoni, a veteran of both Pfizer and Eli Lilly, is described by colleagues as a quiet problem solver who has taken on some of the FDA’s thorniest challenges in her short time at the agency. But her close ties to the drug industry have alarmed a few critics. And the task of running FDA drug approvals during the coronavirus crisis could prove daunting, like caring for a “family of eight, and then you have the four neighbors move in with you,” as one former agency official put it.

Read more.

The real story behind GSK’s whistleblower scandal

Back in 2014, GlaxoSmithKline made headlines around the world after a whistleblower complaint revealed sweeping corruption in its Chinese operation, including the bribery of doctors with cash and sexual favors. It resulted in a prison sentence and a $500 million fine, and the world just moved on.

But that wasn’t the entire story. As David Barboza of the Wire reports, GSK appears to have singled out the wrong employee in its hunt for the whistleblower. The company never caught the actual person who tipped off authorities, Barboza writes, and the real whistleblower has new details and some outstanding questions.

Among them is whether a reward is in the offing. Under federal law, whistleblowers whose tips lead to successful prosecutions are eligible for payouts. And yet a decade after first reporting on GSK’s malfeasance, the whistleblower is yet to yet to hear from U.S. authorities.

Read more.

Sanofi slashes its Covid-19 timeline

Sanofi, the French drug company, has been more cautious than some of its rivals in projecting when its Covid-19 vaccines might be ready. Now, it’s announcing an acceleration of clinical trials to reach the market faster — and striking a $425 million deal to broaden its partnership with Translate Bio to develop one of them. 

The company said its recombinant Covid-19 vaccine could be approved by the first half of 2021, six months earlier than it previously said, and that its new multiple sclerosis drug has entered clinical trials aimed at getting approval.

The company’s head of R&D, John Reed, cited the news as evidence that it is becoming bolder; he also said, in an interview, that the number of committees overseeing drug development have been cut from 33 to 3.

Reed presented new data on a molecule called IL-2, which he has studied for his whole career. It regulates how different types of blood cells behave. Last December, Sanofi spent $2.5 billion to purchase Synthorx, a company that was using artificial DNA base pairs not found in nature to alter IL-2 and produce a drug Reed said could be a “foundational asset” in cancer. The first human data, presented today, show that it produces types of white blood cells, known as natural killer and CD38 cells, known to fight cancer without boosting other parts of the immune system. Full data will be presented at a medical meeting later this year.

Read more.

Sana has a lot of money and little to share

In early 2019, Sana Biotechnology emerged with a light-on-detail plan to corner the market on cell and gene therapies. Today we know, officially, the company has raised $700 million.

As STAT’s Kate Sheridan and Adam Feuerstein report, Sana’s Series A round is by far the largest in recent biotech memory. The company didn’t disclose financial details, but the fundraise undoubtedly makes Sana a unicorn — a private firm with a valuation exceeding $1 billion.

As for what that money buys, Sana CEO Steve Harr taciturn. The company has more than 200 employees tasked with developing cell and gene therapies for a host of conditions including cancer, neurological disease, and genetic disorders. Sana even has an in-house answer to Google’s famed moonshot factory, scientists “pushing those things that we would love to be able to do but we just can’t quite do yet,” Harr said.

Read more.

More reads

  • A Chinese drug maker scores a big clinical trial win with a novel diabetes therapy. (STAT Plus)
  • Biotech analysts see return to normal after virus-driven frenzy. (Bloomberg)
  • Lawmakers push Covid-19 bills to prevent price gouging, track federal funds used to discover drugs. (STAT Plus)
  • What's the hard cost of a pivotal drug trial? A lot less than you might expect. (Endpoints)

Thanks for reading! Until tomorrow,

Tuesday, June 23, 2020


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