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Friday, Dec 11 2015

Full Issue

Gilead Documents Provide Rare Glimpse Into Drug Pricing Decision Making

In other pharmaceutical news, Bayer may have five new cancer drugs on the market by 2020 and AstraZeneca targets the so-called secretome -- proteins secreted by cells -- in the hunt for next-generation biotech medicines. Meanwhile, the FDA is starting to scrutinize the largely unregulated lab-developed test industry.

From the start, the miracle drug was expected to carry a high price tag: $36,000 to treat each patient. Over the two years leading up to the medicine鈥檚 2013 launch, Gilead Sciences Inc. executives and advisers inched the number higher, to about $65,000, then to $81,000, then to $84,000 -- or $1,000 a pill for the 12-week treatment -- as they homed in on a price that was just below where they thought insurers would add significant restrictions for the breakthrough hepatitis C remedy. (Langreth, 12/10)

Bayer AG is packing more cancer drugs into its pipeline to gain a bigger share of the almost $100 billion global market for such treatments. Known for Aspirin and the blood thinner Xarelto, Germany鈥檚 most valuable company had no cancer treatments on the market a decade ago. By the end of this one, Bayer may have as many as five if its research plans pay off. The company has more than doubled the number of cancer medicines in development in the last three years, including treatments that marry radiation and biologics. (Koch, 12/10)

AstraZeneca is diving into the world of proteins secreted by cells - collectively known as the secretome - in the hunt for new drugs and better "cell factories" for making biotech medicines. The so-called secretome accounts for around one third of human proteins and the idea of mapping them all follows the decoding of the human genome in 2000, since when there has been a surge in scientific buzzwords ending in "ome." (Hirschler, 12/10)

The Food and Drug Administration sees lab-developed tests as the Wild West of medicine, citing examples of inaccurate tests it claims put patients at risk. The agency is trying to toughen its supervision next year after largely leaving the business alone for decades and focusing most of its oversight on traditional testing methods. Lab-developed test providers are fighting back. They say their tests are accurate and even lifesaving. Industry officials say heightened regulation could stifle innovation. (Burton, 12/10)

In other聽industry聽news, Voya is suing Millennium Health, and the Valeant executive behind the female libido pill leaves the company -

On the eve of a crucial bankruptcy court hearing, a long-simmering dispute over a $1.8 billion loan to Millennium Health LLC on Wednesday boiled over into a federal-court racketeering lawsuit. Funds associated with Voya Investment Management Co. sued Millennium鈥檚 owners, founder James Slattery and private-equity firm TA Associates Inc., alleging they failed to warn lenders of a Justice Department investigation into the company鈥檚 practices. (Brickley, 12/10)

The head of Sprout Pharmaceuticals, the women鈥檚 libido pill maker that Valeant Pharmaceuticals International Inc. bought for $1 billion, is leaving less than three months after her company was folded into the larger drugmaker. (Koons, 12/10)

This is part of the Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
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