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You are currently browsing the Drug Kennel weblog archives for the day Friday, April 17th, 2009.
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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
505(b)(2) Program: BTG’s Paxclitaxel Gel for Oesophageal Cancer
Published April 17th, 2009 in News Commentary. 0 CommentsMedia is reporting that BTG’s Phase IIa study of a novel gel formulation of paxclitaxel showed tumor reduction in 70% of patients. In effect, BTG is taking a known agent and directly targeting the affected tissues; BTG is also reportedly in later phase trials looking at this gel product in brain cancer - placing the [...]