FDA Approval Decisions Report
August, 2010
| Date: | Aug 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
- Chelsea Therapeutics International, Ltd. (CHTP) - Special Event Report - Second Phase III Study 301 trial data of Northera
- Jazz Pharmaceuticals, Inc. (JAZZ) - Special Event Report - FDA panel review of JZP-6
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
- Alkermes, Inc. (?978543) - Overview - Reports
- Amgen, Inc. (AMGN) - Overview - Reports
- Amylin Pharmaceuticals, Inc. (AMLN) - Overview - Reports
- Savient Pharmaceuticals, Inc. (SVNT) - Overview - Reports
- Bristol Myers Squibb Co. (BMY) - Overview - Reports
- Questcor Pharmaceuticals, Inc. (QCOR) - Overview - Reports
- Eli Lilly & Co. (LLY) - Overview - Reports
- GlaxoSmithKline plc (ADR) (GSK) - Overview - Reports
- Human Genome Sciences (HGSI) - Overview - Reports
- Valeant Pharmaceuticals Intl Inc (VRX) - Overview - Reports
- Johnson & Johnson (JNJ) - Overview - Reports
- Novartis AG (ADR) (NVS) - Overview - Reports
- Pfizer Inc. (PFE) - Overview - Reports
- Teva Pharmaceutical Industries Ltd (ADR) (TEVA) - Overview - Reports
- VIVUS, Inc. (VVUS) - Overview - Reports
- AstraZeneca plc (ADR) (AZN) - Overview - Reports
- Eisai Co., Ltd (ADR) (ESALY) - Overview - Reports
- AVANIR Pharmaceuticals (AVNR) - Overview - Reports
- Roche Holding AG (RHHBY) - Overview - Reports
- Arena Pharmaceuticals, Inc. (ARNA) - Overview - Reports
- ISTA Pharmaceuticals, Inc. (ISTA) - Overview - Reports
- Sanofi (SNY) - Overview - Reports
- Theratechnologies Inc. (THER) - Overview - Reports
- Isotechnika Pharma Inc (IPHAF) - Overview - Reports
- Jazz Pharmaceuticals Inc (JAZZ.1) - Overview - Reports
- Alexza Pharmaceuticals Inc (ALXA) - Overview - Reports
- Chelsea Therapeutics International Ltd. (CHTP) - Overview - Reports
- Warner Chilcott Plc (WCRX) - Overview - Reports
- Cumberland Pharmaceuticals, Inc. (CPIX) - Overview - Reports
- Dainippon Sumitomo Pharma Co Ltd (DNPUY) - Overview - Reports
- Biodel Inc (BIOD) - Overview - Reports
More Information:
Learn more about FDA Approval Decisions Report.