Tag Archives: FDA

Biotech Falls For April Fools’ Prank – Again!

The contenders for becoming the April Fool in Life Sciences for 2012 came down to three candidates, but two of them have persisted past the April 1 deadline, thereby removing themselves from consideration.

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Conference Etiquette – is There an App for That?

There’s a new contagious condition circulating that has even infected the biotech sector: e-Distraction, with bad manner side effects of indecorum, insensitivity and more. The wealthy are often regarded as egocentric and out of touch with reality by the 99…

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The Death of ‘Innocent Until Proven Guilty’?

Unlike every other country in the world at the time, the U.S. founded its judicial system on the premise “innocent until proven guilty.” Under that guiding principle, the burden of proof – in any enforcement action – lies with the…

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The FDA: Stuck in 1984

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…

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

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It’s About the Patient

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…

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Burzynski Institute: Patient Exploitation in the Name of Research

A cursory glance at the website of the Burzynski Research Institute Inc. turns up nothing unusual. The website showcases smiling patients and its shiny, mirror-windowed building. There’s a contact number for patients to call and a prominent “Donate” button, implying…

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The Biotech Toddler Argument: “Chilling Effect on Innovation” Overplayed?

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…

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BioWorld’s Fourth Quarter Biotech Calendar

BioWorld doesn’t have an editorial calendar outlining our planned coverage, because so much of what we write depends on breaking news. That said, here’s a sneak peek at the stories most likely to end up on our cover before the…

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A Little Bit of Certainty Could Go a Long Way

Regulatory certainty. It’s something industry needs and investors want to see. It’s also one of the drivers for job creation. But it’s something our government doesn’t seem to get.

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