FDA Approval Decisions Report
April, 2010
| Date: | Apr 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
- Transition Therapeutics Inc. (TTHI) - Special Event Report - Top-line data from the Phase II AD201 trial of ELND-005
- Regeneron Pharmaceuticals, Inc. (REGNP) - Special Event Report - Phase III PRE-SURGE 1 trial data of Arcalyst
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
- Bristol Myers Squibb Co. (BMY) - Overview - Reports
- Cell Therapeutics, Inc. (CTIC) - Overview - Reports
- Cephalon Inc (?204110) - Overview - Reports
- Questcor Pharmaceuticals, Inc. (QCOR) - Overview - Reports
- Eli Lilly & Co. (LLY) - Overview - Reports
- Genzyme Corporation (?1098629) - Overview - Reports
- Biogen Idec Inc. (BIIB) - Overview - Reports
- Merck & Co., Inc. (MRK) - Overview - Reports
- Novartis AG (ADR) (NVS) - Overview - Reports
- OSI Pharmaceuticals, Inc. (CH716923BCN8001:MSTAR:US) - Overview - Reports
- Pfizer Inc. (PFE) - Overview - Reports
- Par Pharmaceutical Companies, Inc. (PRX) - Overview - Reports
- SuperGen, Inc. (ASTX) - Overview - Reports
- Watson Pharmaceuticals, Inc. (WPI) - Overview - Reports
- AstraZeneca plc (ADR) (AZN) - Overview - Reports
- Bayer AG (BAYRY) - Overview - Reports
- Dendreon Corporation (DNDN) - Overview - Reports
- Eisai Co., Ltd (ADR) (ESALY) - Overview - Reports
- Roche Holding AG (RHHBY) - Overview - Reports
- Actelion Ltd. (ALIOY) - Overview - Reports
- InterMune, Inc. (ITMN) - Overview - Reports
- Salix Pharmaceuticals, Ltd. (SLXP) - Overview - Reports
- POZEN Inc. (POZN) - Overview - Reports
- Sanofi (SNY) - Overview - Reports
- MannKind Corporation (MNKD) - Overview - Reports
- Theratechnologies Inc. (THER) - Overview - Reports
- Zalicus, Inc. (ZLCS) - Overview - Reports
- ChemGenex Pharmaceuticals Limited (ADR) (?348233) - Overview - Reports
- Somaxon Pharmaceuticals, Inc. (SOMX) - Overview - Reports
- Dainippon Sumitomo Pharma Co Ltd (DNPUY) - Overview - Reports
- Covidien plc (COV) - Overview - Reports
More Information:
Learn more about FDA Approval Decisions Report.