Category Archives: Drug Approval

The Good, the Bad and . . . the Huh? A 2011 Biotech Recap

The past year brought the biotech sector a mixed bag of news. Some of it was positive – for instance, the FDA picked up its drug approval pace in 2011 and, in some cases, even surprised the most hardened biotech…

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World’s Oldest Clinical Trial . . . and Health Economics Not Far Behind

How old is our clinical trial system? The first randomized clinical trial was conducted in 1946. British epidemiologist Sir Austin Bradford Hill used randomization to test a pertussis vaccine and a tuberculosis treatment. But according to an article in the…

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Reason Free from Passion? That’s Not Biotech

SAN FRANCISCO ‑ At this week’s BIO Investor Forum in San Francisco, there was talk of how the biotech industry has squandered money, paying for infrastructure when it should have been paying only for development and continuing to fund programs…

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Pfizer’s Greg Simon Talks Change Blindness in Drug Development

If you walked up to a desk to sign a consent form for an experiment, and the person behind the desk bent down to file your form, and a different person stood up – someone with a clearly different face,…

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Unless it’s Affordable, Curing Cancer is Just a Dream

Although they’re the stuff of science, statistics too often lack the power to move us. After all, they’re just numbers. So when companies like Dendreon Corp. and Seattle Genetics Inc. price their cancer treatments at nearly $100,000 or more, we…

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Don’t Price Drugs on What the Market Used to Bear

All those warnings about price pressures and reimbursement woes – they didn’t come from Chicken Little. The sky really could be falling for drugmakers that insist on pricing their products based on what the market used to bear. Rather than…

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Video Coverage from #BIO2011 – Exclusive Interview with AVANIR Pharmaceuticals

Today at the 2011 Bio International Convention, we had the opportunity to speak with Keith A. Katkin, President and Chief Executive Officer of Avanir Pharmaceuticals. Katkin discusses the recent FDA approval of Nuedexta for the treatment of pseudobulbar affect (PBA)….

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LJPC, GNTA Not Dead Yet

It looked Monday as if two of biotech’s long-suffering names might finally be biting the dust. Genta Inc. threw in the towel on beleaguered antisense drug Genasense (oblimersen sodium), after a final analysis of a Phase III melanoma trial –…

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The Public ROI from Drug Prices

Biopharma is often the scapegoat for the escalating cost of healthcare, especially when it comes to the price of brand drugs. But since it’s hard to put a price on health and a long life, what gets lost in this…

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HCV Trials Face Daunting Challenge

Recruiting subjects for ongoing Phase III hepatitis C virus (HCV) trials just got a lot harder. Even if the FDA doesn’t step in and force a change in the standard-of-care control arms after last week’s Antiviral Drugs Advisory Committee meetings,…

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