Esketamine gets a slow rollout, despite boosterism

President Trump took the unusual step of endorsing a prescription drug by name last August, announcing his wholehearted support of esketamine and proclaiming that “results are incredible” with the antidepressant. He was urging the Department of Veterans Affairs, he said, to buy “a lot” of it. 

As of last month, just 15 veterans nationwide had been treated with the nasal spray, STAT’s Megan Thielking writes. And the drug, called Spravato, is only available at seven of the VA’s facilities — out of more than 1,200. 

Part of the reason may be that it just takes time to get new drugs covered and administered. But it's also true that esketamine’s efficacy is still contested by experts: The drug’s data have been “nothing to write home about,” one psychiatrist told STAT. 

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Takeover targets, notable drug launches, and more

What can we expect out of this biotech year? That's what everyone will be talking about next week at the annual J.P. Morgan Healthcare Conference in San Francisco. But why wait? STAT’s Adam Feuerstein gives us his take — projecting even more M&A activity in an already merge-happy sector, among other things. 

Also on the horizon: drug launches that could net big bucks for their makers — including the first-ever NASH drug, made by Intercept Pharmaceuticals. Cell therapies may undergo a shift of fundamentals, with allogenic therapies potentially making it into the limelight. 

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A pattern in December drug approvals 

The end-of-year crunch to approve new drugs has an unintended consequence, according to a new study. Although more drugs are approved in December than any other time of the year, those drugs end up being more associated with hospitalizations and even deaths. 

“We see about twice as many adverse effects,” the Harvard Business School professor who has studied these patterns told the Wall Street Journal. Such surges aren’t exactly deadline-driven, but may happen when applicants rush at year’s end to complete their work. 

Interestingly, drugs that are approved with such such self-imposed deadline constraints end up being more likely to be withdrawn later, have a black box warning, or have dosages discontinued.

Your chance to chat with Sue Desmond-Hellman

Dr. Sue Desmond-Hellman is stepping down from her post as CEO of the Bill and Melinda Gates Foundation. Now, the former UCSF chancellor and Genentech president will be fielding questions from STAT Plus subscribers in an exclusive Q&A session.

What was it like to treat patients with AIDS-related cancer in Uganda? What was her role in spearheading the first gene-targeted therapies for cancer? How did she assess possible projects to fund at the Gates Foundation? 

Submit your questions to Desmond-Hellman before Jan. 10 here. 

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