The Readout Damian Garde & Meghana Keshavan

The FDA rejected Acadia’s drug for reasons the company finds baffling

Acadia Pharmaceuticals said yesterday that the FDA rejected its bid to expand the use of its anti-psychosis drug Nuplazid to a broader group of patients, but the agency’s stated reasoning sounds like a reversal.

As STAT’s Adam Feuerstein reports, the rejection was widely expected following last month’s FDA letter to Acadia citing “deficiencies” in the application. Acadia now has a few more details on the agency’s reasoning, which focused on data from patient subgroups and the design of the study. But the company remains flummoxed by what appears to be a last-minute change of course at the FDA. According to Acadia, the agency agreed to Acadia’s trial design and didn’t raise any concerns about it over the course of its Nuplazid review.

The Acadia case has become a talking point in the debate over whether the FDA has become more strict in 2021, as a number of companies have received surprise letters from the agency that have imperiled what seemed to be likely drug approvals.

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Moderna spent $1.2 million on executive security last year

Or, more accurately, Moderna spent about $188,000 on personal and home security for four of its executives, and then it spent $1 million securing CEO Stéphane Bancel.

That’s according to the company’s annual report, which notes that Moderna “began to provide such services to address increased security concerns as we pursued the development of a Covid-19 vaccine during 2020.” Moderna’s success in that endeavor has brought it worldwide attention, and Moderna previously removed the company’s logo from a manufacturing plant in the name of security.

As FiercePharma points out, stipends for personal security are common corporate expenditures at large drug companies, but the sheer size of Bancel’s bill stands out. Albert Bourla, CEO of fellow vaccine success story Pfizer, ran up a home security tab of $1,114 last year, and Johnson & Johnson CEO Alex Gorsky’s security bill came to $26,085, which includes the value of the company car he takes to work.

Where’s Novavax’s Phase 3 vaccine data?

Novavax, whose Covid-19 vaccine was dramatically effective in a U.K. study, should have data from its U.S. trial any day now, and the results are poised to further complicate the country’s vaccine situation.

Novavax started its study in December and finished enrolling all 30,000 participants in the last week of February. That study is designed to take an interim look at efficacy once there have been 72 confirmed cases of Covid-19, Novavax has said. Considering the pace of infections across the country, that interim analysis should come sooner than later.

And if it’s as positive as the U.K. study, Novavax will quickly file for FDA emergency use authorization. That’s where things could get interesting. Before the FDA can consider Novavax’s application, it will have to review one from AstraZeneca, whose case for authorization is more than a little complicated. It’s already unclear just how much the U.S. needs the AstraZeneca doses it has ordered. If Novavax’s vaccine comes through with higher efficacy and cleaner safety, there might be even less immediacy when it comes to AstraZeneca.

Shareholders pressure Lilly to disclose executive punishments

A group of institutional investors wants Eli Lilly to adopt a policy for disclosing when executive pay is clawed back for misconduct, but the company is refusing to take that advice, even though more than a dozen of its pharmaceutical peers have done so.

As STAT’s Ed Silverman reports, the proposed policy would require Lilly to put out an annual report on all the times it has penalized executives by trimming their bonuses. Among the companies that have adopted it are AbbVie, Pfizer, Bristol-Myers Squibb, and Johnson & Johnson.

But Lilly argues it’s “overly prescriptive and unnecessary.” The company already is subject to SEC rules on disclosing clawbacks. And, because docking pay isn’t the only means of punishing misbehavior, an annual report focused on clawbacks risks painting an incomplete picture of how Lilly handles misconduct, the company said.

Read more.

More reads

  • IL-2 treatment can be dangerous. Here’s how drug firms are trying to fix it. (C&EN)
  • Illumina stock rallies 13% after biotech says it expects Q1 sales to top $1 billion. (MarketWatch)
  • MHRA kicks off new accelerated drug approval pathway with ‘innovation passports.' (Endpoints)

Thanks for reading! Until tomorrow,

Tuesday, April 6, 2021


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