FDA Approval Decisions Report
May, 2009
| Date: | May 01, 2009 |
|---|---|
| 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
- Savient Pharmaceuticals, Inc. (SVNT) - Special Event Report - FDA approval of Krystexxa
- ViroPharma Incorporated (VPHM) - Special Event Report - FDA approval of Cinryze
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
- Alkermes, Inc. (?978543) - Overview - Reports
- Savient Pharmaceuticals, Inc. (SVNT) - Overview - Reports
- Bristol Myers Squibb Co. (BMY) - Overview - Reports
- Cell Therapeutics, Inc. (CTIC) - Overview - Reports
- Discovery Laboratories, Inc. (DSCO) - Overview - Reports
- Eli Lilly & Co. (LLY) - Overview - Reports
- Genzyme Corporation (?1098629) - Overview - Reports
- GlaxoSmithKline plc (ADR) (GSK) - Overview - Reports
- Acura Pharmaceuticals, Inc. (ACUR) - Overview - Reports
- Hemispherx BioPharma, Inc (HEB) - Overview - Reports
- Biogen Idec Inc. (BIIB) - Overview - Reports
- Johnson & Johnson (JNJ) - Overview - Reports
- Medarex inc. (?214788) - Overview - Reports
- Medicis Pharmaceutical Corporation (MRX) - Overview - Reports
- Merck & Co., Inc. (MRK) - Overview - Reports
- Spectrum Pharmaceuticals, Inc. (SPPI) - Overview - Reports
- Northfield Laboratories (?216396) - Overview - Reports
- Novartis AG (ADR) (NVS) - Overview - Reports
- Novo Nordisk A/S (ADR) (NVO) - Overview - Reports
- Pharmaceutical Product Development Inc (?218819) - Overview - Reports
- Teva Pharmaceutical Industries Ltd (ADR) (TEVA) - Overview - Reports
- Titan Pharmaceuticals Inc (TTNP) - Overview - Reports
- ViroPharma Incorporated (VPHM) - Overview - Reports
- Watson Pharmaceuticals, Inc. (WPI) - 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
- Eurand N.V. (?966820) - Overview - Reports
- Sanofi (SNY) - Overview - Reports
- BioDelivery Sciences International, Inc. (BDSI) - Overview - Reports
- Transcept Pharmaceuticals, Inc. (TSPT) - Overview - Reports
- Takeda Yakuhin Kogyo KK (TKPYY) - Overview - Reports
- Advanced Life Sciences Holdings Inc (ADLS.1) - Overview - Reports
- Vanda Pharmaceuticals Inc. (VNDA) - Overview - Reports
- ARCA biopharma, Inc. (ABIO) - Overview - Reports
More Information:
Learn more about FDA Approval Decisions Report.