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September 2011

September 6

Pharmasset Announces 91% SVR12 From the PROTON Trial in Subjects With Hepatitis C Genotype 1 BioDelivery Sciences Announces Positive Results Supporting BEMA Buprenorphine/Naloxone Formulation for Opioid Dependence Phase 2a Study of Selective Oral JAK3 Inhibitor VX-509 Showed Significant Improvements in Signs and Symptoms of Rheumatoid Arthritis AiCuris: No Resistant Herpes Simplex Virus (HSV) Observed in Phase II Trial with Herpes Drug AIC316 Valdoxan (Agomelatine): New Evidence Shows Significant Efficacy in Treatment of Anxiety in Depressed Patients Jennerex Presents Interim Clinical Data of JX-594 Followed by Sorafenib Demonstrating Tumor Responses in Liver Cancer Medical Marijuana Inc.'s Marijuana Extract Cannabidiol (CBD) Possible Use As A Prevention And Treatment To Alzheimer's Disease BioAlliance Pharma: Presentation of Livatag Survival Results at the International Liver Cancer Congress in Hong Kong New Tactic for Controlling Blood Sugar in Diabetes Contradicts Current View of the Disease 4SC's Resminostat Meets Primary Efficacy Endpoint in Phase II Trial in Hodgkin's Lymphoma (HL) OncoGenex Announces Publication of Custirsen Phase II Clinical and Pre-Clinical Data in Leading Cancer Journals Veloxis Pharmaceuticals' Once-Daily LCP-Tacro Meets Non-Inferiority Endpoint When Compared to Twice-Daily Tacrolimus Tablets in Stable Kidney Transplant Patients Furiex Reports Positive Phase II Results for MuDelta in Treatment of Diarrhea-Predominant Irritable Bowel Syndrome Therapeutic Dosing of Synthetic Antimi Further Demonstrates the Potential of microRNA-208 Inhibition in Treatment of Chronic Heart Failure

September 13

LX4211 for Diabetes Shown to Reduce Fasting and Post-Prandial Blood Sugar in Healthy Subjects Innocoll Announces Top-line Results from its Phase 2 Clinical Trial Investigating XaraCol for the Management of Post-operative Pain and Receives "Notice of Allowability" for XaraColl U.S. Patent Application Protalix BioTherapeutics' Taliglucerase Alfa Phase III Results Published in Blood, the Journal of the American Society of Hematology BioLineRx Announces Positive Preliminary Results from Phase I Clinical Trial of BL-1021 for Neuropathic Pain Lyxumia (lixisenatide) one-step treatment regimen as effective as two-step regimen in improving glycemic control in type 2 diabetes Inovio Pharmaceuticals' PENNVAX-G Global HIV Vaccine Plus MVA Boost Achieves 100% Antigen-Specific T-Cell Immune Responses in Interim Phase I Data Medical Marijuana Inc. Marijuana Extract Cannabidiol (CBD) Shows Therapeutic Benefit For Multiple Sclerosis (MS) Positive Results From Avanafil Phase 3 Study in Diabetics Presented at the 47th EASD Annual Meeting Study Finds No Association Between Intracerebral Hemorrhage and Use of Statins Among Patients With Prior Stroke Nasal Insulin Spray Shows Promise In Treatment of Alzheimer's NCCN Expert Discusses Extending Life-Saving Pediatric Treatments to Adults with Acute Lymphoblastic Leukemia Intersect ENT Announces Positive Data from Pivotal Study of Propel Implant, Showing Significantly Improved Outcomes For Sinus Surgery Inovio Pharmaceuticals? PENNVAX?-G Global HIV Vaccine Plus MVA Boost Achieves 100% Antigen-Specific T-Cell Immune Responses in Interim Phase I Data BioAlliance Pharma announces positive preliminary phase I clinical results with its AMEP biotherapy for metastatic melanoma

September 14

Aeterna Zentaris Presents Positive Final Phase 2 Efficacy and Safety Data for AEZS-108 in Advanced Endometrial Cancer at ESGO Meeting in Milan, Italy Nuvo Research provides update on the PENNSAID Viscous Solution development program Combination treatment suggests a comprehensive effect on patients with Alzheimer's disease (AD) - latest study results presented at EFNS Inovio Pharmaceuticals Completes PENNVAX-B HIV Vaccine Phase I Study, Demonstrates Best-in-Class T-Cell Immune Responses Novartis Drug Galvus Shown to Be Well-Tolerated and Effective in Patients With Type 2 Diabetes and Moderate Or Severe Renal Impairment Tekmira and Collaborators Demonstrate Efficacy of RNAi Against Hepatitis C Virus NCCN Guidelines Emphasize Patient Preference as Key to Selection of Maintenance Therapy in Follicular Lymphoma Intarcia Presents Compelling 48-week Results for ITCA 650 - Data Underlines the Promise to Become the First Injection-free GLP-1 Therapy at the 47th Annual EASD Meeting in Lisbon Phase 2 Study of Eculizumab (Soliris) in Patients with Severe and Refractory Generalized Myasthenia Gravis Presented at MGFA Annual Meeting New England Journal of Medicine Publishes Data from Phase 3 ILLUMINATE Study of INCIVEK(telaprevir) in Hepatitis C University of Maryland School of Medicine Scientists Identify First Effective Blood-Stage Malaria Vaccine

September 16

ONGLYZA (saxagliptin) When Added to Insulin in Adults with Type 2 Diabetes Maintained Reductions in Blood Sugar Levels (HbA1c) Over 52 Weeks in Investigational Study Extension Intercell and Biological E. Ltd. announce successful completion of investigational Japanese Encephalitis vaccine pivotal Phase II/III study in India Novartis study showed ACZ885 provided substantial symptom relief in 84% of patients with the most serious form of childhood arthritis Novartis Study Showed ACZ885 Provided Substantial Symptom Relief in 84% of Patients With the Most Serious Form of Childhood Arthritis Chimerix Announces Late-Breaker Presentation at 51st Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) Annual Meeting NPS Pharmaceuticals Highlights Hypoparathyroidism Data to be Presented at Annual Meeting of American Society for Bone and Mineral Research

September 20

Glycotope Enrolls First Patients in Phase I Trial with TrasGEX, a Glycooptimized HER2 Biobetter Antibody Bionovo to Present Tissue Selective Estrogen Receptor Modulators for Obesity at the 22nd Annual Meeting of the North American Menopause Society Active Biotech's Prostate Cancer Project TASQ Featured in Journal of Clinical Oncology Data to be presented at ERS 2011 reinforce benefit of Daxas® (roflumilast) as a treatment to target COPD inflammation Gilead's Second Pivotal Phase 3 Clinical Study of the Investigational Antiretroviral Quad Regimen Meets 48-Week Primary Objective SomaGenics' sshRNA Technology Demonstrates Efficacy of RNAi Against Hepatitis C Virus New clinical and preclinical data on Basilea's novel antibiotic BAL30072 against multidrug-resistant Gram-negative superbugs presented at ICAAC NicOx presents new preclinical data for NCX 6560 Research Suggests FORTEO Significantly Increases Bone Strength Nabriva Therapeutics Presents Extended Phase II Results for Pleuromutilin Antibiotic BC-3781 TheraVasc Releases Phase I Trial Data Demonstrating Safety of Drug in Diabetic Patients New Data on Odanacatib, Merck's Phase III Investigational Cat-K Inhibitor for Osteoporosis, Presented at the Annual Meeting of The American Society for Bone and Mineral Research Niiki Pharma Announces Positive Interim Data from Ongoing Clinical Trial of Novel Anti-Cancer Agent NKP-1339 Lung Cancer Study Reveals Similar Outcomes for African-American and Caucasian Patients Treated With Alimta Rib-X Pharmaceuticals Presents Comprehensive Overview of RX-04 Program in 14 Posters at ICAAC Over 5 Million Children are Currently Treated with ADHD Medication; Study Shows a Majority May Be Unnecessarily Medicated Santarus Announces Supportive Top-Line Results from Budesonide MMX Extended Use Study Continued Treatment For Lupus May Boost Survival of Those Patients with End-Stage Kidney Disease Tarsa Therapeutics Presents Positive Efficacy and Safety Data Comparing Its Oral Calcitonin to Nasal Calcitonin and Placebo in Phase III Osteoporosis Treatment Trial

September 23

European CHMP Adopts Positive Opinion for Eviplera, a Once-Daily Single-Tablet Regimen for the Treatment of HIV Infection Regeneron Announces ZALTRAP Clinical Presentation at European Multidisciplinary Cancer Congress Optimer Pharmaceuticals and Astellas Receive Positive Opinion from CHMP for European Approval of DIFICID ImmunoGen, Inc. Announces Submission of IND for Wholly Owned Product Candidate for Non-Hodgkin's Lymphoma Novartis Gains Positive CHMP Opinion for Rasitrio, First Rasilez-Based Triple Combination Pill in Europe to Treat High Blood Pressure Edurant (rilpivirine) Receives Positive Opinion From the Committee for Medicinal Products for Human Use (CHMP) for Use in Treatment-Naive Adults with HIV-1 European Medicines Agency Recommends Authorisation of Novel Antibiotic Agent Alexion Receives CHMP Positive Opinion for Soliris (eculizumab) in Patients with Atypical Hemolytic Uremic Syndrome (aHUS) in the European Union CHMP Post-Authorisation Summary of Opinion for Alimta (II-33) Novartis Drug Afinitor Effective in Patients With Non-Cancerous Kidney Tumors Associated With TSC in Phase III Trial Results of a Pivotal Phase 3 Efficacy and Safety Study for Butrans (Buprenorphine) Transdermal System CIII Published in The Journal of Pain

September 26

Novartis Drug Afinitor Helps Women With Advanced Breast Cancer Live Significantly Longer Without Their Disease Progressing Pacira Pharmaceuticals, Inc. Announces Efficacy and Safety of EXPAREL Highlighted at "Hot Topics in Plastic Surgery" Panel at the 2011 Annual Meeting of the American Society of Plastic Surgeons New Data Demonstrate Longer-Term Safety Profile of Esbriet Clermont Pharmaceuticals Reports Positive Phase III Results for Drug to Treat Glaucoma Topiramate Exposure and Fetal Outcomes in Migraine Patients to Be Presented at the 136th ANA Annual Meeting Aeterna Zentaris Announces Interim Data for its Phase 1/2 Trial with AEZS-108 in Prostate Cancer at ESMO Congress - AEZS-108 well tolerated at all dose levels / Early evidence of anti-tumor activity ARIAD Announces Long-Term Follow Up of Patients with Drug-Resistant CML Treated with Ponatinib in Phase 1 Trial Study of Zolinza (vorinostat) for Investigational Use for Advanced Malignant Pleural Mesothelioma Did Not Meet Primary Endpoint Synta Announces Presentation of Results of Ganetespib Study in Combination with Docetaxel in Solid Tumors Newly Identified DNA Repair Defect Linked to Increased Risk of Leukemia Relapse Regulatory Update: GlaxoSmithKline Receives Complete Response Letter from FDA for candidate meningococcal and Hib combination vaccine Upsher-Smith Laboratories Presents Extended-Release Topiramate Data (USL255) at ANA Meeting ALIMTA Helped Keep Most Common Form of Lung Cancer at Bay In Elderly Patients Pearl Therapeutics' Bronchodilator Combination PT003 Provides Superior Inspiratory Capacity Compared to Spiriva Update: OncoSec Announces Positive Results From Head & Neck and Breast Cancer Trials Constellation Pharmaceuticals Announces Publication Demonstrating Pharmacological Suppression of Key Cancer-causing Gene Report Finds DMARDs Effective in Treating Juvenile Arthritis Encore Therapeutics Inc. Announces Extended Release Depot Formulation of Ropivacaine Available for License

September 27

BioLineRx to Present Data from the Successfully Completed Phase IIb Trial of BL-1020 at European Conference on Schizophrenia Research Biodel Reports Top-Line Results From Pump Study of Experimental Insulins Pulmatrix's PUR118 Demonstrates Potential to Reduce Acute Exacerbations of the Lung Associated with Progressive Respiratory Diseases, such as COPD, Asthma, CF, and Respiratory Infections Neurocrine Biosciences Announces Elagolix Scientific Presentations at the 67th Annual Meeting of the American Society for Reproductive Medicine Oramed Pharmaceuticals Announces Successful Phase 1 Clinical Trial Results for EnteraBio Interim Data Announced for BIBF 1120 as Compared to bevacizumab in Combination Chemotherapy in Metastatic Colorectal Cancer Transition Therapeutics Announces Publication of ELND005 Phase 2 Clinical Study Data in Alzheimer's Disease Edurant (Rilpivirine) Receives Positive Opinion From the Committee for Medicinal Products for Human Use (CHMP) for Use in Treatment-Naïve Adults With HIV-1 Circassia?s Hay Fever Treatment Improves Patients? Allergy Symptoms in Phase II Clinical Trial New Novartis Data Show Potential of Respiratory Portfolio to Help COPD Patients Maintain Active and Productive Lives Biofrontera delivers final documents for processing the last open issues in the drug application of BF-200 ALA Shire Provides Update on ProAmatine (midodrine HCl) Youth with Diabetes More Likely to Have Asthma

September 28

Chelsea Therapeutics Submits New Drug Application for Northera (droxidopa) for the Treatment of Symptomatic NOH Independent Radiology Assessment Panel Results Confirm Statistical Significance of Response and Progression Endpoints of Cell Therapeutics' Pixantrone PIX301 Pivotal Trial Novo Nordisk files for regulatory approval of the ultra-long-acting insulins Degludec and DegludecPlus in Europe Positive Results for V158866 in Phase I Study Nih Modifies 'Voice' Hiv Prevention Study in Women Oral Tenofovir Discontinued in Clinical Trial MolMed presents new data from four clinical trials on NGR-hTNF at European Multidisciplinary Cancer Congress Pulmatrix?s PUR118 Demonstrates Potential to Reduce Acute Exacerbations of the Lung Associated with Progressive Respiratory Diseases, such as COPD, Asthma, CF, and Respiratory Infections COPD patients experienced benefits from the first dose when treated with aclidinium, as shown in the ATTAIN Phase III study BioDelivery Sciences Announces Results from Phase 3 Efficacy Study for BEMA Buprenorphine in Chronic Pain

September 29

Almirall Announces Regulatory Filing of linaclotide for the Treatment of Irritable Bowel Syndrome With Constipation in Europe Transcept Pharmaceuticals Resubmits Intermezzo NDA to FDA Otonomy Presents Positive New Findings From Phase 1b Study of OTO-104 in Meniere's Disease at International Conference Telik Announces Publication in the Journal Cancer of a Phase 2 Randomized Multicenter Study of Two Extended Dosing Schedules of Oral Ezatiostat in Low to Intermediate-1 Risk Myelodysplastic Syndrome Pronova and Takeda Announce the Submission of a New Drug Application for TAK-085 in Japan Orexigen Therapeutics Announces Multiple Contrave Data Presentations at the 29th Annual Scientific Meeting of The Obesity Society Unexpected Link Between Cancer and Diabetes Revealed Additional Analysis from Two-Year Sequel Study of QNEXA Featured at The 2011 Annual Scientific Meeting of The Obesity Society

September 30

Pfizer Reports Top-Line Results Of A Phase 3 Clinical Trial Comparing The Efficacy And Safety Of VFEND® (voriconazole) And ERAXISTM (anidulafungin) Combination Therapy To VFEND Alone In Invasive Aspergillosis Ironwood Announces Linaclotide European Regulatory Submission for the Treatment of Irritable Bowel Syndrome with Constipation Topline Results: A Randomized Phase 2 Study of Selumetinib in Patients with KRAS-Mutant Non-Small Cell Lung Cancer Baxter Submits European Marketing Authorization Application For HyQ, an Investigational IG Therapy for Primary Immunodeficiencies Results of the Pharmaceutical Affairs Subcommittee Regarding the Application of Epogin for Chemotherapy-Induced Anemia Bayer AG: Phase III Study of Bayer?s Rivaroxaban in Patients with Acute Coronary Syndrome Meets Primary Efficacy Endpoint

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