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Wednesday, August 31, 2016

The Readout by Damian Garde & Meghana Keshavan

Welcome to The Readout, your daily source for all things biotech. Follow us on Twitter for more: @damiangarde@megkesh, and of course, @statnews.

Theranos' reboot hits a major snag

Theranos, blinkered by a federal crackdown, has rallied around a new technology that promises to run a battery of blood tests from a portable device. But its latest efforts have already run into trouble, The Wall Street Journal reports. Theranos withdrew its bid to win FDA clearance for a Zika virus test after regulators found that the company failed to follow protocols designed to safeguard patients while testing the new device. 

Yet another biosimilar comes to the US (eventually)

Novartis won FDA approval for its take on Amgen's blockbuster anti-inflammatory treatment Enbrel, marking the third biosimilar cleared in the US.

The injection is called Erelzi, and it's now approved for all the diseases treated by Enbrel despite only being tested in psoriasis — something Amgen protested earlier this year. Enbrel generates more than $5 billion a year for Amgen, and those sales are expected to take a hit when biosimilar competition arrives.

But the "when" in that sentence is unclear. The two companies are still fighting over patents, and Novartis said only that it's "fully committed to bringing Erelzi to US patients and payers as soon as possible."

And the price? It's "too early to speculate," according to a Novartis spokesman.

Should biotechs model themselves after the airline industry?

A top financial services firm has a vision for biotech, and it looks a lot like ... American Airlines.

Don't worry: The good people at KPMG aren't calling for life sciences companies to introduce more delays and fees. They just think biotech would be wise to follow the airline industry's playbook on outsourcing services.

The airlines emerged from the financial crisis in large part by contracting out services like catering, baggage handling, fueling, and cabin cleaning to third-party organizations. The biotech industry will be primed to thrive if it does the same thing with contract research organizations, predicts KPMG's new report. "The lessons for life sciences organizations are clear — finding the natural owner of non-core activities, move decisively, and put everything on the table," the report says. 

Sounds reasonable enough — as long as biotechs don't follow the airlines' lead in running ads telling consumers to behave better.

Sponsor content by amgen

6 things you may not know about biotech medicines

Biotechnology medicines, particularly biologics, have grown to be important treatment options for patients with cancer, blood disorders, rheumatoid arthritis, cardiovascular disease, and many other illnesses. But this wasn’t always the case. A number of pivotal innovations paved the way for early biotech medicines — and today additional innovations continue to emerge out of R&D labs and from the highly sensitive manufacturing environments where these medicines are made.  Read more here.

The drug pricing war is heating up in California

With the drug industry's reputation tanking, "pharma shill" is becoming an increasingly potent political insult.

That helps explain a new website from the campaign pushing to lower drug prices in California through a ballot initiative in November. Called "Follow the Drug Dollars," the site names state lawmakers and groups opposing the measure — and puts dollar figures on their ties to the drug industry. (Drug companies like Merck and Pfizer have contributed $86 million to fight the measure, and a surprising number of patient groups are opposing it too.)

The "No" campaign, for its part, has been insisting its allies aren't being swayed by financial ties to pharma and simply believe the ballot initiative is flawed policy.

Who wants to grow marijuana for research?

Earlier this month, the DEA declined to lift restrictions that limit biomedical research on marijuana. But it did move to expand the number of sites authorized to grow the plant.

So are universities lining up to supply marijuana to the feds? Not exactly, STAT's Andrew Joseph reports.

More reads

  • Cardiologists weigh in on the years-long decline of new medicines developed in the field. (Cardiobrief)
  • Vectura's treatment for COPD failed in a late-stage trial. (Reuters)
  • Rigel Pharmaceuticals said its platelet-boosting drug succeeded in a Phase 3 study. (TheStreet)
  • The University of Minnesota is suing Gilead Sciences, claiming its multibillion-dollar hepatitis C franchise infringes a school patent. (Minneapolis/St. Paul Business Journal)

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Thanks for reading! Until tomorrow,

Damian & Meghana

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