AveXis’s problems date back farther than we thought

Before the AveXis data manipulation issue that would blossom into a proper scandal for parent company Novartis, the gene therapy developer had already run afoul of FDA regulations.

As STAT’s Ed Silverman reports, FDA inspectors noted that AveXis discovered issues with its mouse test back in October 2018. The problem stemmed from AveXis’s use of “a non-validated spreadsheet” to calculate preclinical data, according to the FDA, and inspectors left the site satisfied that the company had righted its wrongs.

That reads a bit ominous now. It was manipulated data from that same site that ended up getting submitted to the FDA. Novartis executives got wind of the problem some time in May but decided not to tell the FDA until late June. And in August, after all this came to light, they insisted it wasn’t a systemic issue at AveXis.

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What does ‘anti-competitive’ mean nowadays, anyway?

A minor subplot to biopharma in 2019 is concern that the FTC is quietly cracking down on drug companies, with the best illustration being Bristol-Myers Squibb’s protracted effort to close its merger with Celgene. But yesterday’s news on that front made it all a bit confusing.

Celgene sold the anti-inflammatory drug Otezla to Amgen in a move meant to appease an FTC that was apparently concerned Bristol-Myers might do something monopolistic if it owned both Otezla and BMS-986165, a pipeline therapy meant to treat the same diseases. That seemed like a harsh interpretation in the minds of many analysts, as Otezla and BMS-986165 have different mechanisms of action.

But in light of the Amgen deal, one wonders how exactly the FTC is defining anti-competitive behavior. Amgen already markets Enbrel, a multibillion-dollar treatment for inflammatory disease, and it has a biosimilar of Humira, AbbVie’s top-selling drug that happens to be Enbrel’s biggest competitor. Now it’s adding Otezla, which is to say that instead of owning two similar medicines, as Bristol-Myers-Celgene would have, Amgen will market three, and this is apparently OK by regulators.

Remembering one of the good guys in biotech

Mark Schoenebaum, a superlatively well-respected biotech analyst, died over the weekend. He was 46.

What endeared people to Schoenebaum, according to STAT’s Adam Feuerstein, was not just his aptitude and encyclopedic mind for the drug industry but also his warmth, humor, and generosity.

“I’m heading into my 20th year covering biotech, which makes me 1) very old, but 2) uniquely qualified to place Mark’s Wall Street career in its proper perspective,” Adam writes. “So, I say this without a hint of hyperbole: Mark was the most influential sell-side analyst that I’ve ever known.”

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Grail is making a move on Washington

Grail, the lavishly funded liquid biopsy startup, just hired one of the drug industry’s most powerful lobbyists to do its work in Washington.

Rodger Currie, who recently made the surprising decision to step down from his perch as PhRMA’s top lobbyist, will soon be Grail’s head of public affairs and “alliance development,” the company said yesterday.

Grail’s business is based on the idea of developing blood tests that can detect cancer in healthy people. The company is yet to prove its technology in large trials — and thus quiet its skeptics — but hiring Currie suggests Grail believes it will eventually need to convince the government that paying for such a test is a good idea.

The company, now on its third CEO in as many years, has raised $1.6 billion in investments and commands a reported $3.2 billion valuation.

AveXis’s problems date back farther than we thought

What does ‘anti-competitive’ mean nowadays, anyway?

The 2019 STAT Summit: The Next Breakthroughs

Remembering one of the good guys in biotech

Grail is making a move on Washington

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