Thursday, April 26, 2018

The Readout by Damian Garde & Meghana Keshavan

Welcome to The Readout, where we keep you on top of the latest in biotech. For more in-depth coverage of biopharma, subscribe to STAT Plus. On Twitter: @damiangarde@megkesh, and @statnews.

Is Acadia in trouble?

Acadia Pharmaceuticals' share price has flagged since an April story by CNN that highlighted serious and sometimes fatal side effects tied to its recently approved treatment for symptoms of Parkinson's disease. Now FDA Commissioner Scott Gottlieb has promised to "go back and take another look." 

Gottlieb mentioned the FDA's reconsideration of the issue before a House committee last week, but it seemed to escape most everyone's attention until yesterday, when the company's stock price fell another 22 percent. An FDA spokeswoman confirmed via email that the agency "is conducting an evaluation of available information about Nuplazid. This review has been going on for several weeks. We have nothing more to share at this time."

So what will become of Acadia's drug, called Nuplazid? It already carries a black box on its label, warning of serious health risks. In the past, when confronted with post-approval safety concerns, the FDA has convened independent experts to tell it what to do. That's what happened to GlaxoSmithKline's diabetes drug Avandia, which ended up staying on the market. It also happened to Merck's Vioxx, which did not.

As for Acadia, investors seem to fear the worst: Yesterday the company's shares closed at their lowest value since mid-2013.

Amazon's last bid to disrupt the drug business didn't exactly pan out

The year was 1999., then a fledgling e-commerce company, was about to blow up the drug industry. 

“Farewell, Preparation H aisle," read a Globe and Mail headline about Amazon's acquisition of, which, as its name implies, sought to do for pharmaceuticals what its dot-com brethren had in mind for pets, jobs, and bike messengers.

That didn't happen, as STAT's Casey Ross reports. no longer exists and never recorded an annual profit.

So what does that portend for Amazon's current efforts in health care?

Read more.

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'Right to try' is coming to your TV

"Right to try," the movement to make unapproved drugs more available to patients, may have stalled in Congress, but its billionaire benefactors haven't given up.

As STAT's Erin Mershon reports, the Koch-backed group Americans for Prosperity is spending hundreds of thousands of dollars in a renewed effort to get right to try passed, an ad campaign that will include TV and digital spots.

“Terminally ill patients are running out of time. Access to experimental treatments could save their lives,” a woman says over simple images of hospital hallways, doctors and patients, including a mother and child in an inpatient room and another young woman with a headwrap hugging a child.

Read more.

Why its hard to change things in health care, Vol. XVI

Wouldn't it be great if instead of filling out endless forms and staring down months-old magazines in antiseptic waiting room, you could just have a video chat with a doctor and end it with a prescription?

That's the dream behind Lemonaid Health, a telemedicine startup that counts Novartis among its investors. But the sclerotic realities of health care have made the pursuit of that dream more difficult than Lemonaid expected, throwing up hurdles in the form of murky state regulations, lying patients, and a requirement for technology out of the 1980s.

Read more.

More reads

  • Amgen still has no magic pill to solve its zero-growth problem. (STAT Plus)
  • Prothena’s Pronto failure raises pipeline doubts. (EP Vantage)
  • The Hong Kong Exchange finalized its rules for biotech companies trying to go public. (BioCentury)
  • Shire bid marks Takeda's latest — and biggest — push for global status. (Reuters)

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