FDA Approval Decisions Report
March, 2009
| Date: | Mar 01, 2009 |
|---|---|
| Format: | |
| Price: | $125.00 |
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
- Alkermes, Inc. (?978543) - Overview - Reports
- Amylin Pharmaceuticals, Inc. (AMLN) - Overview - Reports
- Bristol Myers Squibb Co. (BMY) - Overview - Reports
- Discovery Laboratories, Inc. (DSCO) - Overview - Reports
- Eli Lilly & Co. (LLY) - Overview - Reports
- Genentech, Inc. (?248964) - Overview - Reports
- Genzyme Corporation (?1098629) - Overview - Reports
- GTC Biotherapeutics Inc (?941955) - Overview - Reports
- GlaxoSmithKline plc (ADR) (GSK) - Overview - Reports
- Hemispherx BioPharma, Inc (HEB) - Overview - Reports
- Johnson & Johnson (JNJ) - Overview - Reports
- Medarex inc. (?214788) - Overview - Reports
- Medicis Pharmaceutical Corporation (MRX) - Overview - Reports
- Northfield Laboratories (?216396) - Overview - Reports
- Novartis AG (ADR) (NVS) - Overview - Reports
- Novo Nordisk A/S (ADR) (NVO) - Overview - Reports
- Titan Pharmaceuticals Inc (TTNP) - Overview - Reports
- AstraZeneca plc (ADR) (AZN) - Overview - Reports
- Bayer AG (BAYRY) - Overview - Reports
- King Pharmaceuticals, Inc. (?212886) - Overview - Reports
- United Therapeutics Corporation (UTHR) - Overview - Reports
- H. Lundbeck A/S (HLUKY) - Overview - Reports
- Roche Holding AG (RHHBY) - Overview - Reports
- Dyax Corp. (DYAX) - Overview - Reports
- Salix Pharmaceuticals, Ltd. (SLXP) - Overview - Reports
- Sanofi (SNY) - Overview - Reports
- Acusphere Inc (ACUSD) - Overview - Reports
- Accentia Biopharmaceuticals Inc (ABPI) - Overview - Reports
- Takeda Yakuhin Kogyo KK (TKPYY) - Overview - Reports
- Somaxon Pharmaceuticals, Inc. (SOMX) - Overview - Reports
- Vanda Pharmaceuticals Inc. (VNDA) - Overview - Reports
- ARCA biopharma, Inc. (ABIO) - Overview - Reports
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