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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.
Also posted in Global, Marketing, Regulatory, Strategy, Technology Tagged Allergan, CEOs, MAP Pharmaceuticals, Migraine, PDUFA 2 Comments
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.
Also posted in Advertising, Corporate Responsibility, Legal, Marketing, Regulatory, compliance, leadership Tagged DDMAC, Genentech, OPDP, Roche Leave a comment
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
Also posted in Advertising, E-Media, Legal, Marketing, Regulatory, Technology, compliance, social media Tagged FDA Leave a comment
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 [...]
Also posted in Agency Insight, Biotech, Deals Tagged BIOCOM, Joe Panetta, M&A, venture capital Leave a comment
Pfizer Proactive in Birth Control Pill Recall