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The Readout Damian Garde & Meghana Keshavan

How an FDA leadership vacuum may be impacting reviews

The FDA has no permanent commander in chief — and that may be making regulators far more cautious and conservative in their drug reviews. Or not. But, as STAT's Adam Feuerstein writes, there's at least some evidence of the former possibility.

Take Acadia Pharmaceuticals: The company said Monday that it received a surprise notice from the FDA, which noted  “deficiencies” in its application for expanded access for its anti-psychosis drug Nuplazid. The decision came a month before the company was expecting any word at all. Fibrogen, too, recently received a surprise FDA notice that threw off its own drug review timeline. 

Read more.

Former FDA chiefs urge Biden to find a new leader

A cadre of former FDA commissioners are pressing President Biden to nominate a new leader for the agency, stat. A letter signed by six former officials — from both sides of the aisle — underscores the need for a new commissioner to help guide the agency during the ongoing pandemic. While the letter doesn’t specifically endorse any particular candidate, it does praise acting commissioner Janet Woodcock, STAT’s Nicholas Florko writes

“Across Democratic and Republican administrations, we have worked closely with Dr. Woodcock across a range of critical issues,” the letter says. “Dr. Woodcock is a highly effective advocate for advancing the FDA’s mission — a role she has continued from her first day as Acting Commissioner.”

Read more.

Quench Bio announces shut down via Twitter

Quench Bio seemed to have everything going for it: an experienced CEO, blue-chip investors, and a large enough series A to set up shop in prime biotech real estate in Cambridge’s Kendall Square. The company was even named one of the most promising biotech startups in a September list.

But over the last few weeks, the company’s investors, leaders, and scientists realized they could go no further. Quench announced it was winding down its operations in an unusually public way: via Twitter thread.

“Being transparent about successes and failures in biotech is critical to share the learnings, as most of the insights are lost when you bury the dead at night,” Bruce Booth, a partner at Atlas Venture and a member of Quench’s board, told STAT's Kate Sheridan.

Despite years of work, the company hadn’t been able to find a compound capable of drugging a particular target, known as gasdermin D.  “We wished for a different outcome. But I think we did the best we could with the data we have,” CEO Samantha Truex told STAT yesterday afternoon. “Admitting that [experiments] failed, and moving on to the next thing — it's actually the best thing for the patients.”

The company auctioned off the crystal structures in exchange for a donation to Life Science Cares Boston; a yet-to-be-named company won the auction. Quench will also be publishing its work in the future.

Abbisko Therapeutics may go public

China’s Abbisko Therapeutics is planning a $250 million IPO in Hong Kong, Bloomberg writes. The cancer-focused biotech has already raised a fair deal of cash from backers like Warburg Pincus — most recently, a $123 million Series D round in January. The company is developing small molecule drugs for targeted therapies, with a focus on cancers that are most prevalent in China — such as lung, liver, and gastric tumors. 

The company, which was founded in 2016, is currently partnered with AstraZeneca on a drug that inhibits tumor growth by working on the fibroblast growth factor receptor, or FGFR. It’s also working on a diabetes treatment with China-based Youngene. 

More reads

  • Deerfield, Coridea launch NYC medtech incubator. (FierceBiotech)
  • The 10 most innovative companies in biotech. (Fast Company)
  • The top 10 drugs losing U.S. exclusivity in 2021. (FiercePharma)

Thanks for reading! More tomorrow,

Damian

Wednesday, March 10, 2021

STAT

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