FDA Approval Decisions Report
February, 2012
| Date: | Feb 01, 2012 |
|---|---|
| Format: | ZIP |
| Price: | $125.00 |
Abstract
The Revere FDA Approval Decision Report report provides one of the most comprehensive and accurate event calendars for PDUFA dates (Prescription Drug User Fee Act) -- expected FDA approval dates for NDA/BLA filed drugs in the next 3 months and reviews all FDA approval decisions in the current month.
Furthermore, the report also analyzes each drug candidate's likelihood of approval and competitive landscape using 3 criteria derived from Revere's patented classification system:
- Utilization of a mechanism of action previously approved by the FDA.
- Facing two or fewer alternative drugs with the same mechanism of action for the same indication.
- Would be the first or second FDA approved drug for the company.
Included Bonus New BioMedicine Biotech Research Reports
- Amylin Pharmaceuticals, Inc (AMLN) - Special Event Report - FDA approval of Bydureon
- Titan Pharmaceuticals, Inc (TTNP) - Special Event Report - Phase III open-label trial data of Probuphine
Each New BioMedicine Biotech Research Report provides in-depth analysis relating to an upcoming event for a select pipeline drug. The report forecasts the expected event outcome (positive/negative), and discusses the relevant company, the drug candidate, market opportunity, clinical trials results, and competitive landscape.
The Biotech Research Report is unique in its focus on events likely to drive large price movements within narrow timeframes, and because it forecasts event outcomes based on rigorous analysis of clinical results and regulatory factors.
Companies Mentioned in the Report
- Allergan Inc (AGN) - Overview - Reports
- Amgen Inc (AMGN) - Overview - Reports
- Amylin Pharmaceuticals Inc (AMLN) - Overview - Reports
- Bristol Myers Squibb Co (BMY) - Overview - Reports
- Discovery Laboratories Inc (DSCO) - Overview - Reports
- Elan Corporation PLC (ELN) - Overview - Reports
- Eli Lilly & Co (LLY) - Overview - Reports
- Gilead Sciences Inc (GILD) - Overview - Reports
- GlaxoSmithKline PLC (GSK) - Overview - Reports
- Biogen IDEC Inc (BIIB) - Overview - Reports
- Nektar Therapeutics (NKTR) - Overview - Reports
- Insys Therapeutics Inc (NEOL) - Overview - Reports
- Novartis SA (NVS) - Overview - Reports
- Pfizer Inc (PFE) - Overview - Reports
- Progenics Pharmaceuticals Inc (PGNX) - Overview - Reports
- Astex Pharmaceuticals, Inc. (ASTX) - Overview - Reports
- Teva Pharmaceutical Industries Ltd (TEVA) - Overview - Reports
- Vertex Pharmaceuticals Inc (VRTX) - Overview - Reports
- Vivus Inc (VVUS) - Overview - Reports
- Watson Pharmaceuticals Inc (WPI) - Overview - Reports
- Astrazeneca PLC (AZN) - Overview - Reports
- Eisai Co Ltd (ESALY) - Overview - Reports
- Biosante Pharmaceuticals Inc (BPAX) - Overview - Reports
- Salix Pharmaceuticals Ltd (SLXP) - Overview - Reports
- Columbia Laboratories Inc (CBRX) - Overview - Reports
- Affymax Inc (AFFY) - Overview - Reports
- Corcept Therapeutics Inc (CORT) - Overview - Reports
- Takeda Yakuhin Kogyo KK (TKPYY) - Overview - Reports
- Chelsea Therapeutics International Ltd (CHTP) - Overview - Reports
- NeurogesX Inc (NGSX) - Overview - Reports
- MAP Pharmaceuticals Inc (MAPP) - Overview - Reports
- Alkermes PLC (ALKS) - Overview - Reports
More Information:
Learn more about FDA Approval Decisions Report.