FDA Approval Decisions Report
January, 2010
| Date: | Jan 01, 2010 |
|---|---|
| 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
- Sangamo Biosciences, Inc. (SGMO) - Special Event Report - Phase 2 announcement of SB-509
- Ariad Pharmaceuticals, Inc. (ARIA) - Special Event Report - Phase 3 announcement of Ridaforolimus
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
- Abbott Laboratories (ABT) - Overview - Reports
- AP Pharma Inc (APPA) - Overview - Reports
- Alkermes, Inc. (?978543) - Overview - Reports
- Amylin Pharmaceuticals, Inc. (AMLN) - Overview - Reports
- Biospecifics Technologies Corp (BSTC) - Overview - Reports
- Cephalon Inc (?204110) - Overview - Reports
- Eli Lilly & Co. (LLY) - Overview - Reports
- General Electric Co (GE) - Overview - Reports
- Gilead Sciences, Inc. (GILD) - Overview - Reports
- GlaxoSmithKline plc (ADR) (GSK) - Overview - Reports
- Merck & Co., Inc. (MRK) - Overview - Reports
- OSI Pharmaceuticals, Inc. (CH716923BCN8001:MSTAR:US) - Overview - Reports
- Pfizer Inc. (PFE) - Overview - Reports
- Par Pharmaceutical Companies, Inc. (PRX) - Overview - Reports
- Shire Plc. (ADR) (SHPGY) - Overview - Reports
- AstraZeneca plc (ADR) (AZN) - Overview - Reports
- SkyePharma PLC (ADR) (SKYEY) - Overview - Reports
- Roche Holding AG (RHHBY) - Overview - Reports
- Dyax Corp. (DYAX) - Overview - Reports
- Endo Pharmaceuticals (ENDP) - Overview - Reports
- Actelion Ltd. (ALIOY) - Overview - Reports
- Salix Pharmaceuticals, Ltd. (SLXP) - Overview - Reports
- Fibrocell Science Inc (FCSC) - Overview - Reports
- Santarus, Inc. (SNTS) - Overview - Reports
- XenoPort, Inc. (XNPT) - Overview - Reports
- MannKind Corporation (MNKD) - Overview - Reports
- Auxilium Pharmaceuticals, Inc. (AUXL) - Overview - Reports
- Zalicus, Inc. (ZLCS) - Overview - Reports
- Takeda Yakuhin Kogyo KK (TKPYY) - Overview - Reports
- Acorda Therapeutics Inc. (ACOR) - Overview - Reports
- ChemGenex Pharmaceuticals Limited (ADR) (?348233) - Overview - Reports
- Pharmaxis Ltd. (ADR) (PXSLY) - Overview - Reports
- Somaxon Pharmaceuticals, Inc. (SOMX) - Overview - Reports
- Warner Chilcott Plc (WCRX) - Overview - Reports
- Cadence Pharmaceuticals, Inc. (CADX) - Overview - Reports
- Dainippon Sumitomo Pharma Co Ltd (DNPUY) - Overview - Reports
- Covidien plc (COV) - Overview - Reports
More Information:
Learn more about FDA Approval Decisions Report.