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The Readout Damian Garde & Meghana Keshavan

A storied biotech personality returns to the CEO ranks

The executive who presided over two formative decades of Biogen’s history is taking another biotech CEO job, stepping in at Editas Medicine as the CRISPR-focused company prepares to disclose its first clinical data.

Jim Mullen, previously Editas’s chairman, becomes the company’s third CEO since its foundation. In an interview with STAT’s Adam Feuerstein, Mullen said the chance to lead a genome editing startup was “too good to resist.” He likened it to joining Biogen in 1989, when the company had no products and only around 200 employees.

“I think about all the transitions and phases that successful companies go through to develop the technology and products, well, I’ve seen that movie before,” Mullen said. “It was a lot of fun. It’s a lot of hard work but there are great lessons that I bring from that, and I hope to share them with the new team.”

Read more.

Biden’s FDA decision pits ‘a steady hand’ against a ‘reformer’

Readers of the Los Angeles Times opened their papers Sunday to find an uncommon sight: a full-page ad endorsing a candidate to lead the FDA.

As STAT’s Ed Silverman reports, the process of choosing the next FDA commissioner has become a public tug of war in recent weeks, focused on Janet Woodcock, a long-standing agency official, and Joshua Sharfstein, a public health academic who has also served at the agency. The ad, which endorsed Woodcock, followed an open letter from more than a dozen prominent academics calling for Sharfstein to get the job.

To her admirers, Woodcock is an adept regulator with unrivaled institutional knowledge and a record of working with disparate players in health care, including drug companies. To critics, she’s too sympathetic to the industry she polices. Sharfstein, by contrast, “has the more traditional FDA commissioner profile for a new Democratic administration,” Ramsey Baghdadi, a co-founder of the consulting firm Prevision Policy, which includes public health experience and no ties to industry.

“Woodcock is viewed as the steady hand and Sharfstein as the reformer,” Baghdadi said. “Take your pick.”

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How long does Reddit luster last?

Cassava Sciences, a little-known biotech firm with an investigational treatment for Alzheimer’s disease, is up about 850% since the start of 2021 thanks in large part to a frenzy of interest from retail traders. But, with interest already waning in retail darlings like GameStop, will Cassava’s many new shareholders stick around for the ups and downs of drug development?

The root of Cassava’s sudden fame is a Feb. 2 press release describing interim results from 50 patients in a trial with no placebo control. More than 76 million shares changed hands that same day, with multiple trading halts and Reddit posts along the way.

Now Cassava is a $2.1 billion company with a long road ahead. Yesterday, Cassava laid out its plans for 2021, which include a second interim analysis from its open-label trial and, in the second half, a pair of placebo-controlled Phase 3 trials meant to establish the drug’s benefits. Whether retail traders will have turned their attention by then remains to be seen.

An EU crackdown on human rights abuses has pharma looking closer at supply chains

The European Union is moving forward with a law that would hold companies accountable for human rights abuses and environmental damage, leading to some unease for drug companies that rely on a global network of suppliers that could expose them to liability.

As Jessica Davis Plüss writes in STAT, the new law would legally mandate that companies conduct due diligence on their business, including supply chains. Most major drug companies have been doing some version of this voluntarily, experts said, but the threat of legal liability will undoubtedly lead to action.

Pharma has fewer issues with supply chain malfeasance than other sectors, experts said, but the drug industry’s increasing reliance on firms in China and India brings the risk of exposure to human rights and environmental abuses.

Read more.

More reads

  • A Q&A with WHO’s emergencies chief on Covid-19, why he’s hopeful, and when normalcy might return. (STAT)
  • Glaxo’s growth problem. (Evaluate Vantage)
  • It’s not the ‘British variant.’ It’s B.1.1.7. (STAT)
  • Former Galena chief Mark Ahn back in hot water as DOJ levels insider trading charges for consultant work. (Endpoints)

Thanks for reading! Until tomorrow,

Tuesday, February 9, 2021


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