Category Archives: BLA

Biosimilar regulation: 1984 v. 2014

It’s 1984. The year opens with the demise of Ma Bell, as the Bell System is broken into smaller, regional telephone companies. The idea is to end Ma’s nationwide monopoly, but the result is a handful of smaller monopolies since there…

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Patient Experience Still Undervalued in Regulating Drugs

As I write this, I’m sitting in the University of British Columbia/Vancouver General Hospital (UBC/VGH) Eye Care Centre, where my husband, Chuck, is completing post-tests at the conclusion of a six-month study on prosopagnosia, otherwise known as face blindness. The…

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He Said What?!?! Best Biotech Quotes of 2011

As BioWorld Insight readers know, our “Word on the Street” column provides a sample of the most entertaining and thought-provoking quotes our staff stumbles upon each week. Some are gathered during interviews, some gleaned from analyst reports, and some overheard…

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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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The Scariest Thing about Dendreon’s Implosion

As a biotech junkie, I’ll admit I was shocked to the core by Dendreon Corp.’s second-quarter admission that prostate cancer vaccine Provenge (Sipuleucel-T) is thus far not succeeding commercially. (See BioWorld’s news bulletin for details.) The most shocking part? Analyst…

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