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The Readout Damian Garde & Meghana Keshavan

STAT Madness kicks off today! Vote for the year's coolest biomedical innovations here.

Woodcock’s cancer focus: Asset or albatross?

The legacy of the FDA's Janet Woodcock is built on drug approvals: She’s known for pushing the envelope at the agency, giving the green light to a record-breaking number of cancer therapies. Last year, for instance, the FDA approved 17 different cancer drugs. In 2000, by contrast, it approved just three. She’s personally championed efforts to fast-track such drugs through the FDA’s typically arduous review process.  

It's no wonder the country’s top cancer doctors are  lobbying the Biden administration to make Woodcock the new FDA commissioner, as STAT’s Nicholas Florko writes. Critics, however, say that Woodcock has helped erode the FDA’s gold standards — and allowed drugs to be approved without clear proof of efficacy. 

“Janet is not helping anybody by putting drugs on the market if they don’t work,” one critic told STAT. 

Read more.

Finch gunning for a $100 million IPO

Microbiome player Finch Therapeutics plans to go public with a $100 million IPO, according to SEC documents filed Friday. The offering’s success or failure could be the first major test of a long-held assumption: that good clinical data from live biotherapeutics companies will buoy public investor interest in the space.

Finch and two other companies, Seres Therapeutics and Rebiotix, announced positive topline results from pivotal trials of microbiome-based C. difficile therapeutics over the summer. Rebiotix is privately held, but Seres saw its share price quintuple on the news.

Finch’s SEC filing also revealed new details about the company’s relationship with OpenBiome — the non-profit stool bank that announced last week it would wind down its operations after a year-long hold. Finch said it will pick up some of the organization’s equipment, contracts, and banked stool samples for about $5 million.

The two organizations have been linked for many years both as collaborators and through their leadership teams. OpenBiome was co-founded in 2013 by Finch CEO Mark Smith and Carolyn Edelstein; Smith and Edelstein are also married. 

Johnson & Johnson vaccine approved 

In case you missed it — and we doubt you did — Johnson & Johnson’s one-dose Covid-19 vaccine was authorized late Saturday. And yesterday, CDC Director Rochelle Walensky signed off on a recommendation that it be used widely from the Advisory Committee on Immunization Practices, an expert panel that advises the agency. 

The first doses of the vaccine, which was found to be 72% effective in the U.S., are expected to ship this week, STAT’s Rachel Cohrs writes. Supplies are going to be scarce until at least April.

Read more.

AstraZeneca gets in on Junshi’s antibody drug

AstraZeneca plans on marketing an anti-PD-1 cancer drug from China-based Shanghai Junshi Biosciences. The therapy, called toripalimab, targets urothelial carcinoma, and has also been approved as a second-line treatment for metastatic melanoma in China. AstraZeneca has been granted rights to market toripalimab across China, and the two companies are in talks to expand distribution of the drug in emerging markets, Bloomberg writes

Junshi also announced a month ago that it would partner with Bay Area biotech Coherus BioSciences to develop toripalimab in the U.S. and Canada. Junshi receive up to $1.11 billion in biobucks from Coherus for the co-development rights.

More reads

  • Thailand kicks off Covid-19 vaccine program with Sinovac shots. (Bloomberg)
  • Cancer patients often can’t get full care with covid-19 bogging down medical facilities. (Washington Post)
  • Could fruit flies help match patients with cancer treatments? (Wired)

Thanks for reading! More tomorrow,

Damian

Monday, March 1, 2021

STAT

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