Washington. Healthcare. Translated.

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Biosimilars: Reading FDA’s Tea Leaves

When biosimilars hit FDA, what will be the review criteria? Everyone cares, since so much is at stake. The market for generic versions of eligible biologics might soon reach $20 bil. Recent FDA actions might hint at the new era. In a Citizen Petition for Lovenox (Aventis), FDA shared its review guidelines for approving a generic.…

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From the President’s Desk

Those who know me will raise an eyebrow, even drop a jaw, at hearing of the evolution from solo-based consulting into a more formal firm. The obvious question is, why. Those who know me well seem too shocked to even ask. I love working solo: diverse work, flexibility for home time with our special kids,…

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Medical Devices: Next on the Chopping Block?

Folks may just waking up to the impact that health reform will have on their businesses. Not just doctors or hospitals, and not the health care sector alone. Everybody. But even industries active in the pre-passage negotiations might find themselves blindsided by regulatory developments both within health reform and beyond. One such group may be…

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DIALYSIS: Above All, Do No Harm

Every few years, a new industry becomes the apparent victim of Medicare’s regulatory wrath. First, the power scooter market, then the eye surgeons, then power scooters again. The latest proposed cuts in ESRD – big cuts, in case the world of dialysis isn’t your regular thing – give some the impression that dialysis clinics are…

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The Conversation” on New Drug Pricing: Are We There Yet? Part I: Policy perspectives on Sovaldi and other Hepatitis C drugs

We all know that someday, the US will need to tackle a long-avoided national “conversation” on healthcare… the one   Like the kid in the back seat, I wonder, “Are we there yet?” This time, it seems hepatitis C drugs like Sovaldi are bringing us… really close. Learning why we’re close but not there, requires…

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Solvaldi and “The Conversation” on New Drug Pricing: Are We There Yet? (Part II – Sovaldi and the Hepatitis C marketplace, 2014)

We all know that someday, the US will need to tackle a long-avoided national “Conversation” on healthcare… the one that comes when the price of a new drug outstrips the economy’s ability to cover. Like the kid in the back seat, I wonder, “Are we there yet?” This time, it seems hepatitis C drugs like…

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