While 2012 has dawned everywhere else in the world, it’s still 1984 at the FDA. With its Bad Ad program, whistle-blower suits and spotters of conference crimespeak serving as its globalwise eyes and ears, the agency has adopted Big Brother…
Category Archives: FDA
He Said What?!?! Best Biotech Quotes of 2011
December 29, 2011 – 3:26 pm
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…
It’s About the Patient
December 13, 2011 – 8:11 pm
An FDA advisory committee this week gave a half-hearted vote of approval – 9-8, with two abstentions – for Alexza Pharmaceuticals Inc.’s Adasuve (Staccato loxapine). But the vote was conditioned on limiting the inhaled antipsychotic to one dose per day…
The Biotech Toddler Argument: “Chilling Effect on Innovation” Overplayed?
November 18, 2011 – 1:24 pm
In last week’s issue of BioWorld Insight, our esteemed Washington editor Mari Serebrov wrote an article titled, “Shorter Exclusivity Could Carry a Hefty Price Tag.” In it, she quoted sources who are very concerned that reducing the current 12-year exclusivity…
Drug Shortages? We Ain’t Seen Nothin’ Yet
October 6, 2011 – 11:18 am
You think the drug shortage is a devil now
It’s Time for Biopharma to Speak Up
August 24, 2011 – 11:14 am
Free speech. Most of us take it for granted. Unless you’re a drug company, that is. Since the FDA doesn’t trust biopharma when it comes to drug promotion, the agency believes that, as the watchdog of public health, it’s justified…
Biopharmas Should Explore Better Ways to Make and Regulate Drugs to Avoid Shortages
August 10, 2011 – 3:36 pm
What’s causing drug shortages in the U.S., and is it a matter of mechanisms of control or methods of drug production? In 2010, there were shortages of 178 drugs in the U.S., a record-high level. Many drugs on the 2010…
The Scariest Thing about Dendreon’s Implosion
August 4, 2011 – 1:37 pm
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.
Equal Standards of Disclosure
June 10, 2011 – 7:54 pm
Disclosure and transparency. They’re recurring themes often sung by lawmakers and critics who would have us believe that even the gift of a drug-labeled pen will put doctors and medical students under the influence of biopharma.
Join the Conversation