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The Readout Damian Garde

So much for Amarin’s best-laid plans


Had Amarin gotten its way, this is how things would have worked: Summer would have quietly faded into fall, regulators would have stayed quiet, and approval for an expanded use of its heart drug Vascepa would have been secured by late September. Then, blockbuster sales.

But, nope. Yesterday, Amarin said the FDA has scheduled a Vascepa advisory committee meeting for Nov. 14. The drug’s approval deadline will be extended. Those pesky regulators have questions and possible concerns about the heart drug derived from fish oil. Amarin beach vacations: canceled.

Read more.

Why did Novartis keep a scandal to itself?


Who knew what and when? And is there such thing as too much Peloton time?

We discuss all that and more on the latest episode of “The Readout LOUD,” STAT’s biotech podcast. We went all Novartis this week, explaining the shocking news that the Swiss pharma giant submitted falsified data to the FDA and then waited three months to inform regulators. We discuss what we know, what remains unanswered, the implications for Novartis’s corporate rebrand, and why this was awkward timing for Vas Narasimhan, the company’s ascendant CEO.

You can listen to the episode here. To listen to future episodes, be sure to sign up on iTunes, Stitcher, Spotify, or wherever you get your podcasts.

Speaking of confusing corporate communications


Yesterday, Sarepta Therapeutics’ share price dropped after a report that a patient in one of the company’s trials experienced a serious side effect, something the company described as “erroneous.”

The issue stems from Sarepta’s ongoing study of a gene therapy for Duchenne muscular dystrophy. A report of one child in the trial needing to be hospitalized popped up on the FDA’s public database of drug side effects, which sent Sarepta shares down about 13% before trading got halted.

That might seem like a disproportionate reaction, but safety issues have plagued DMD gene therapies under development at Pfizer and Solid Biosciences, which might explain investor skittishness about Sarepta.

Read more.

Indeed

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So while the biopharma world chewed over the Novartis situation, parsed the Sarepta statement, and processed the Amarin news, Nektar Therapeutics went and halted its stock, too.

The problem, Nektar revealed after hours yesterday, is that the company produced some “suboptimal” batches of a cancer drug used in a melanoma trial. That, according to management, may have dampened the effect of its drug, bempegaldesleukin, which was tested alongside Bristol-Myers Squibb’s blockbuster Nivolumab.

On the one hand, that suggests Nektar’s unpronounceable therapy might be more potent than previously thought. On the other hand, it suggests Nektar has a problem when it comes to manufacturing that drug, which doesn’t exactly bode well for the future.

More reads

  • The world’s most expensive medicine could save toddlers’ lives. But getting it is complicated. (STAT Plus)
  • Bayer buys out BlueRock, betting at least $240 million more on cell therapy. (Xconomy)
  • Q&A: The FDA’s digital health chief on how to regulate futuristic AI products. (STAT Plus)
  • New life of lab equipment makes science possible for researchers returning to their home countries. (STAT)

Thanks for reading! Until next week,

Megan

Friday, August 9, 2019

STAT

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