Category Archives: FDA

Unmet Need in the Migraine Space?

Allergan CEO David Pyott is bullish on Botox’s potential as a salve for chronic migraine. He’s also betting on a next-gen dihydroergotamine (DHE) – Levadex – from MAP Pharmaceuticals.
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Genentech Runs Voluntary Corrective Ads for Boniva

Even though Roche-owned Genentech wasn’t required to run costly corrective advertisements following an FDA Untitled Letter on Boniva last January, the company has done so anyway.
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Off-Label Comments Online: Keep Doing What You're Doing, Says FDA

Those in favor of a less is more approach to FDA social media guidelines got what they wanted for the holidays: a trim, 15-page document on how to respond to unsolicited off-label comments
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Putting the M Back in M&A

Joe Panetta, president and CEO of BIOCOM, discusses an emerging model of M&As in which human and IP assets are valued and biotech brings expertise to Big Pharma as venture capitalist funding dwindles and patent cliffs loom large. Pharm Exec: Can you tell me about how small biotech and specialty companies have started switching from relying [...]
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Why the Delay on Facts Boxes?

Despite a near-complete absence of criticism coming from industry, academia, clinicians and patients, the drug facts box – a concise, quantitative, easy-to-read format for presenting a drug’s risk/benefit profile in print advertisements – seems at least three years away from launch.
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