FDA Approval Decisions Report
November, 2007
| Date: | Nov 01, 2007 |
|---|---|
| Format: | |
| View Report » |
Abstract
The Revere FDA Approval Decision 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 particular, this report identifies Biotech/Pharmaceutical companies with expected FDA approvals 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: (1) Utilization of a mechanism of action previously approved by the FDA, (2) Facing two or fewer alternative drugs with the same mechanism of action for the same indication, and (3) Would be the first or second FDA approved drug for the company. Original, unbiased, insightful and actionable, the Revere FDA Approval Decision Report is an indispensable tool for successful Biotech/Pharmaceutical investing.
Companies Mentioned in the Report
- Wyeth (?200696) - Overview - Reports
- Bristol Myers Squibb Co. (BMY) - Overview - Reports
- DepoMed, Inc. (DEPO) - Overview - Reports
- Elan Corporation PLC (ELN) - Overview - Reports
- Soligenix Inc (SNGXD) - Overview - Reports
- Forest Laboratories, Inc. (FRX) - Overview - Reports
- Fresenius Medical Care AG & Co. KGaA (FMS) - Overview - Reports
- Genentech, Inc. (?248964) - Overview - Reports
- Genzyme Corporation (?1098629) - Overview - Reports
- GlaxoSmithKline plc (ADR) (GSK) - Overview - Reports
- Impax Laboratories Inc (IPXL) - Overview - Reports
- Biogen Idec Inc. (BIIB) - Overview - Reports
- ImClone Systems Incorporated (?211711) - Overview - Reports
- Johnson & Johnson (JNJ) - Overview - Reports
- Ligand Pharmaceuticals Inc. (LGND) - Overview - Reports
- Merck & Co., Inc. (MRK) - Overview - Reports
- Mylan Inc. (MYL) - Overview - Reports
- Spectrum Pharmaceuticals, Inc. (SPPI) - Overview - Reports
- Neurocrine Biosciences, Inc. (NBIX) - Overview - Reports
- CARDIOME PHARMA CORP (CRME) - Overview - Reports
- Novartis AG (ADR) (NVS) - Overview - Reports
- Noven Pharmaceuticals, Inc. (?216699) - Overview - Reports
- Onyx Pharmaceuticals, Inc. (ONXX) - Overview - Reports
- Pharmacyclics, Inc. (PCYC) - Overview - Reports
- Progenics Pharmaceuticals, Inc. (PGNX) - Overview - Reports
- Regeneron Pharmaceuticals, Inc. (REGN) - Overview - Reports
- Solvay SA (SVYZY) - Overview - Reports
- Bayer AG (BAYRY) - Overview - Reports
- SkyePharma PLC (ADR) (SKYEY) - Overview - Reports
- BioMarin Pharmaceutical Inc. (BMRN) - Overview - Reports
- Roche Holding AG (RHHBY) - Overview - Reports
- DOV Pharmaceutical, Inc. (DOVP.5) - Overview - Reports
- ZymoGenetics Inc (?647652) - Overview - Reports
- Sanofi (SNY) - Overview - Reports
- Omrix Biopharmaceuticals, Inc. (?357441) - Overview - Reports
- MiddleBrook Pharmaceuticals, Inc. (?690831) - Overview - Reports
- Theravance, Inc. (THRX) - Overview - Reports
- Jazz Pharmaceuticals Inc (JAZZ.1) - Overview - Reports
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