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BioWorld - Sunday, February 22, 2026
Home » Topics » Regulatory » BLA

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Biosimilar regulation: 1984 v. 2014

Feb. 19, 2014
By Mari Serebrov
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 still is no telephone competition. The Soviet Union leads a boycott of the Summer Olympics being held in Los Angeles, presumably as payback for the U.S. boycott of the 1980 Moscow Games, which was, in turn, a response to the Soviet war in Afghanistan. Even though Time named the computer the “Machine of the Year” two years ago, personal computers...
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Patient Experience Still Undervalued in Regulating Drugs

Oct. 28, 2013
By Marie Powers
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 condition isn’t treatable with drugs – not yet, at least – but it’s nonetheless disabling, prompting researchers at several centers in North America and Europe to work collaboratively and seek to help patients carry on with their lives. Clinical studies of prosopagnosia have, so far, informed researchers more about the causes and structural manifestations of the disease than about potential...
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The Scariest Thing about Dendreon’s Implosion

Aug. 4, 2011
By Trista Morrison
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 and investor assumptions that Provenge’s poor performance is due not to reimbursement hurdles, as Dendreon claimed, but to an underlying lack of demand. Doctors and patients don’t want to use the product. Come again? Are you serious? Provenge is the first and only therapeutic cancer vaccine ever to gain FDA approval. I don’t have to tell anyone in the biotech...
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