Margo paid a visit to Camargo this week. She helped us celebrate our 5 years of helping clients with their drug development needs.
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You are currently browsing the Drug Kennel weblog archives for the day Saturday, June 7th, 2008.
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- Failed 505(b)(2)?: Vivus’ Qnexa
- Will We Have Generic User Fees? Public Meeting To Be Held.
- Lannett’s Morphine Sulfate Oral Solution: 505(b)(2) or 505j?
- Generic Lovenox – 505j or 505(b)(2)
- New User Fees for 2011
- Still submitting paper ANDA applications?
- What should a license cost?
- Avandia: Who Won?
- Advisory Committee Meeting: Rosiglitazone
- The skinny on a potential new treatment of obesity
Indevus’ Stock drops 70% on FDA’s request for more safety data
Published June 7th, 2008 in News Commentary. 0 CommentsOn June 4, Indevus Pharmaceuticals reported that the FDA is likely to request additional safety data before approving NEBIDO®, its depot testosterone product for the treatment of male hypogonadism. The news sent the stock on a tumble - losing $2.46 to $1.26/share (a 70% decline) in the subsequent trading period (it has since recovered a bit, Friday’s [...]