upcoming events this month:
Event Date Brand Name Event Originator Licensee(s) Therapeutic Categories Pharma Class
14-Oct-08 Femara (Litigation) Motion Hearing (Mylan case) Novartis AG Cancer
Aromatase Inhibitors
14-Oct-08 Cinryze (Product) PDUFA expected Lev Pharmaceuticals, Inc. Cardiovascular
Enzyme Inhibitors
15-Oct-08 Acapodene (Product) FDA guidance expected GTx Inc. GTx Inc.
Ipsen SA (formerly known as Beaufour IPSEN)
Cancer
Hormonal disorder
Selective Estrogen Receptor Modulators
15-Oct-08 Ranexa (Product) (Licensing) PDUFA expected CV Therapeutics, Inc CV Therapeutics, Inc
Quintiles Transnational Corp.
The Menarini Group
Cardiovascular
Cardiovascular Agents
Sodium Channel Inhibitors
15-Oct-08 Tricor (Litigation) Telephone Conference (Teva case) Solvay SA Cardiovascular
Metabolism
Lipotropics (Fibric Acid Derivatives)
17-Oct-08 Protonix (Litigation) Status Conference (Teva case) Wyeth (formerly known as American Home Products Corporation) Gastrointestinal
Proton Pump Inhibitors
18-Oct-08 Acapodene (Product) Phase III results expected GTx Inc. GTx Inc.
Ipsen SA (formerly known as Beaufour IPSEN)
Cancer
Hormonal disorder
Selective Estrogen Receptor Modulators
19-Oct-08 Promacta (Product) PDUFA expected GlaxoSmithKline plc GlaxoSmithKline plc
Immunomodulation
Blood Formation Products (Erythropoietins)
19-Oct-08 ferumoxytol (Product) PDUFA expected AMAG Pharmaceuticals, Inc. (formerly known as Advanced Magnetics, Inc.) 3SBio Inc.
Cytogen Corporation
Blood and forming organs
Diagnostic
Genito-urinary
Imaging Contrast Agents
20-Oct-08 Pulmicort (Litigation) Motion Hearing (Teva case) AstraZeneca PLC Respiratory
Corticosteroids-Inhalation / Nasal
21-Oct-08 Myozyme (Product) FDA Advisory Committee meeting Genzyme Corporation Metabolism
Enzyme Replacements/Modifiers Anti-cystine Agents
21-Oct-08 Telavancin (Product) FDA decision expected Theravance Inc Astellas Pharma Inc. (formerly Yamanouchi Pharmaceutical Co., Ltd.)
Infectious disease
Respiratory
Antibacterials (Glycopeptide Antibacterials)
22-Oct-08 XL184 (Licensing) Opt-in date for GSK Exelixis Inc. Cancer
Central Nervous System
Tyrosine Kinase Inhibitors
VEGFR2 Inhibitors
23-Oct-08 Allegra (Litigation) Telephone Conference (consolidated) Sanofi-Aventis SA Sciele Pharma, Inc.
Allergy
Dermatological
Antihistamines (Histamine1 (H1) Blocking Agents, Mildly/Non-sedating)
24-Oct-08 picoplatin (Product) Phase II results expected Poniard Pharmaceuticals Poniard Pharmaceuticals
Cancer
Antineoplastics
Cancer Agents
24-Oct-08 deforolimus (Product) Phase III results expected Ariad Pharmaceuticals Merck & Co., Inc.
Cancer
Antiangiogenic Agents
Antineoplastics
Receptor Protein Kinase Interactions
26-Oct-08 CP-690550 (Product) Phase IIb results expected Pfizer Inc. Immunomodulation
Immune Suppressants (Immune Suppressants (Non-TNF Inhibitors))
26-Oct-08 ARRY-797 (Product) (Licensing) Phase II results expected Array BioPharma, Inc. Cancer
Antineoplastics
27-Oct-08 alogliptin (Product) PDUFA expected Takeda Pharmaceutical Company Limited (formerly Takeda Chemical Industries) PPD Inc. (Pharmaceutical Product Development Inc.)
Metabolism
Antidiabetic Agents (Dipeptidyl Peptidase-4 (DPP-4) Inhibitors)
28-Oct-08 Isentress (Product) Phase III results expected Merck & Co., Inc. Infectious disease
HIV Integrase Inhibitors
28-Oct-08 Prevnar (Product) Phase III results expected Wyeth (formerly known as American Home Products Corporation) Infectious disease
Vaccines / Antisera
28-Oct-08 Orencia (Product) Phase II/III data Repligen Corporation Gastrointestinal
Immunomodulation
Proteins
29-Oct-08 R788 (Product) (Licensing) Phase IIa results expected Rigel Pharmaceuticals, Inc. Cancer
Immunomodulation
Tyrosine Kinase Inhibitors
29-Oct-08 PF-4383119 Phase II results expected Pfizer Inc. Genentech Inc
Musculoskeletal
CNS, Miscellaneous
29-Oct-08 Puricase (Product) Phase III results expected Savient Pharmaceuticals Inc. (formerly Bio-Technology General Corp) Musculoskeletal
Antigout
29-Oct-08 INCB18424 (Product) Phase II results expected Incyte Corporation (formerly Incyte Pharmaceuticals, Incyte inc, Incyte Genomics) Blood and forming organs
Cancer
Dermatological
Immunomodulation
Molecular Target Inhibitors (Multitargeted Kinase Inhibitors, Bcr-Abl/c-kit Receptor Tyrosine Kinases)
30-Oct-08 Vimpat (Product) PDUFA expected UCB S.A. Central Nervous System
Musculoskeletal
Anticonvulsants
Sodium Channel Interactions
31-Oct-08 interleukin-21 (Product) Phase II results expected ZymoGenetics, Inc. Novo Nordisk A/S
Cancer
Antineoplastics
31-Oct-08 Gardasil (Product) sBLA decision expected Merck & Co., Inc. Beijing Wandong Medical Equipment Co. Ltd. (MRI operation)
C & M Communication
Cancer
Genito-urinary
Immune Stimulants (Vaccines to Prevent Papillomavirus Disease)
31-Oct-08 Effient (Product) PDUFA expected Eli Lilly and Company Eli Lilly and Company
Cardiovascular
Platelet Aggregation Inhibitors (Adenosine Diphosphate P2Y12 Inhibitors)
31-Oct-08 Stalevo (Product) Phase III results expected Orion Corporation Novartis AG
Central Nervous System
Catechol O-methyltransferase (COMT)
Dopamine Precursors
31-Oct-08 Remodulin (Product) Phase III results expected United Therapeutics Corporation Goldshield Group plc
Grupo Ferrer Internacional SA
Nova-Tex, Ltd.
Orphan Australia Pty Ltd
Paladin Labs Inc.
Cardiovascular
Prostacyclin Receptor Agonists
31-Oct-08 Treanda (Product) PDUFA expected Cephalon, Inc. Eisai Co., Ltd.
SymBio Pharmaceuticals Limited
Cancer
DNA Damaging Drugs
31-Oct-08 Ranexa (Product) (Licensing) PDUFA expected CV Therapeutics, Inc CV Therapeutics, Inc
Quintiles Transnational Corp.
The Menarini Group
Cardiovascular
Cardiovascular Agents
Sodium Channel Inhibitors
31-Oct-08 milnacipran (Product) PDUFA expected Cypress Bioscience, Inc. Cypress Bioscience, Inc.
Forest Laboratories Inc
Central Nervous System
Serotonin / Norepinephrine Reuptake
31-Oct-08 Provenge (Product) Phase III results expected Dendreon Corporation Cancer
Vaccines / Antisera
31-Oct-08 asenapine (Product) PDUFA expected Schering Plough Corporation Pfizer Inc.
Central Nervous System
Receptor Interactions
31-Oct-08 TriLipix (Product) FDA decision on NDA expected Abbott Laboratories Cardiovascular
Dyslipidemics (Fibrates)
31-Oct-08 IDX184 Phase I results expected Idenix Pharmaceuticals Inc Infectious disease
Hepatitis C Agents
Inhibitors
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