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October 2009

October 1

FDA Issues Draft Guidance on Risk Evaluation and Mitigation Strategies Halozyme Presents Phase 2 Results for Regular Insulin-PH20 Confirming Faster Insulin Absorption and Superior Glucose Control Bristol-Myers Squibb and ZymoGenetics to Present Final Phase Ib Data on PEG-Interferon Lambda at AASLD 2009 WILEX AG: Preliminary data of MESUPRON show impressive increase in overall survival of patients with pancreatic cancer XOMA Presents Results Demonstrating Novel Mechanism of Action for XOMA 052 in Regulating IL-1 Beta Levels Study Shows AFRESA Provides Rapid Suppression of Endogenous Glucose Production in Diabetes Patients Scientists Report Impressive Research Results with Tβ4 on First Day of Thymosin Meeting Positive Interim Data from Minnow Medical Peripheral Artery Disease Trial Presented at TCT 2009 Conference BreastCancerTrials.org and Largest Breast Cancer Trial Announced Drug That Crosses Blood-Brain Barrier Reduces Formation Of Brain Metastases In Mice Telik Announces Publication of Positive Phase 1-2a Results of a Multicenter Study of TELCYTA(R) in Combination With Carboplatin and Paclitaxel in Patients With Advanced Non-Small Cell Lung Cancer Sanofi Pasteur Announces Results of U.S. Clinical Trials in Adults Following One Dose of Influenza A (H1N1) Vaccine

October 2

Updated Advaxis Phase I Survival Data Indicates Long-Term Immune Protection RegeneRx's Tβ4 Significantly Improves Functional Recovery in Multiple Sclerosis Animal Model Additional Analysis Confirms Significant Symptomatic Benefit of Droxidopa in Treatment of Neurogenic Orthostatic Hypotension LifeCycle Pharma Announces Positive Results from a 12 Month Extension Phase of the Phase 2 Clinical Study of LCP-Tacro Once Daily in Stable Liver Transplant Patients Ardea Biosciences to Present Results from a Phase 2a Study of RDEA594 at the 2009 ACR/ARHP Annual Scientific Meeting ImmunoCellular Therapeutics' Antibody Shows Promise in Detecting Pancreatic and Lung Cancer in Serum Test Dapagliflozin Study Demonstrated Significantly Improved Glycemic Control and Weight Reduction in Type 2 Diabetes Patients Inadequately Controlled with Metformin AFRESA Phase 3 Data Show Sustained Glycemic Control, Normal Lung Function in Patients over Four Years of Treatment Compelling new data on Novartis' oral MS therapy Immutep Announces Final Results In Advanced Renal Cell Carcinoma KYTHERA Biopharmaceuticals Presents Positive Data From Two Phase 2 Studies With ATX-101 Amicus Therapeutics Announces Preliminary Results of Phase 2 Study with Plicera for Gaucher Disease Video: New Analysis Supports Tolerability of Lexiscan (regadenoson) Injection for Pharmacologic Myocardial Perfusion Imaging Studies Array BioPharma to Present Clinical Results on Diabetes Drug at European Diabetes Meeting Intercept Pharmaceuticals' FXR Agonist INT-747 Meets Primary Endpoint in a Phase II Clinical Trial in Type 2 Diabetic Patients with Nonalcoholic Fatty Liver Disease

October 3

Newly Published Phase III Data Show Novartis Drug Sandostatin LAR Depot Reduced Risk of Disease Progression by 66% in Advanced NET Patients OPAXIO Produces High Rates of Pathologic Complete Remission in Patients with Advanced Esophageal Cancer; Study Paves Way for Potential Registration Trial as Radiation Sensitizer KYTHERA Biopharmaceuticals Announces Presentation of Phase 2 Data on Novel Fat Reduction Drug at ASDS Meeting Ulcerative Colitis Treatment Reduces Need for Surgery by Almost Half InteKrin Therapeutics Presents Positive INT131 Phase 2b Results at the 45th Annual European Association for the Study of Diabetes Meeting Orexigen Therapeutics Phase 2b Trial for Empatic Meets Primary Efficacy Endpoint Demonstrating Significantly Greater Weight Loss Versus Comparators in Obese Patients InteKrin Therapeutics Presents Positive Long Term INT131 Preclinical Cardiovascular Safety Data at the 45th Annual European Association for the Study of Diabetes Meeting

October 5

SAGE launches "Genes & Cancer" Promising Clinical Data with RegeneRx's Tβ4 Drug Candidates Presented on Second Day of Thymosin Meeting Transdel Pharmaceuticals to Host Conference Call and Webcast on Tuesday, October 6, 2009 to Announce Top-Line Phase 3 Study Results for Lead Topical Pain Drug Ketotransdel(R) Two Phase III Studies of Lucentis Show Early and Sustained Improvement in Vision in Patients with Retinal Vein Occlusion Study Finds That Onglyza (saxagliptin) When Added To Metformin Was Non-Inferior To JANUVIA (SITAGLIPTIN) When Added To Metformin In Reducing Hemoglobin (HbA1c) In Adults With Type 2 Diabetes Mellitus Positive Phase II Results for GSK1838262 (XP13512) Reported for Subjects with Post-Herpetic Neuralgia and a History of Inadequate Response to Gabapentin Depomed, Inc. Announces Positive Top-Line Results from Phase 3 Clinical Trial of DM-1796 in Postherpetic Neuralgia Avila Presents Preclinical Data on its Novel, Orally-Available, Pan-Genotype Protease Inhibitor, AVL-181, Demonstrating Protein Silencing of Hepatitis C Virus Long-Term Data from Landmark Phase 3 Safety and Nutritional Study Evaluating Alnara Pharmaceuticals' Liprotamase in Patients with CF to be Presented at 2009 North American Cystic Fibrosis Conference Nymox Announces New Pooled Analysis Confirms 12 Month Benefit of NX-1207 Treatment for BPH Cocaine Vaccine Shows Promise for Treating Addiction ThromboGenics Announces Results From a Phase IIa Trial Evaluating Microplasmin for the Treatment of Diabetic Macular Edema (MIVI II DME) Peregrine Pharmaceuticals Reports Positive Results From Phase II Bavituximab Lung Cancer Trial Molecular Insight Pharmaceuticals Presents Azedra Efficacy Data in Neuroendocrine Tumors

October 12

Depomed Reports Results From Two Phase 3 Clinical Trials Evaluating Non-Hormonal Therapy for Menopausal Hot Flashes Raptor Pharmaceutical Reports Positive Interim Phase 2a Clinical Data in Non-Alcoholic Steatohepatitis (NASH) Topline Results from Phase 2 Clinical Trial of Oral NKTR-118 Presented at 20th American Academy of Pain Management Annual Clinical Meeting (AAPM) in Phoenix NOXXON Pharma AG Announces Excellent Preliminary Phase I Trial Results for Spiegelmer NOX-E36 ? Good Safety and Pharmacodynamic Profile and Additional Good Subcutaneous Bioavailability Synta Pharmaceuticals Announces Updated Elesclomol SYMMETRY Data Presented at Melanoma XIII Avodart (dutasteride) in combination with tamsulosin shows benefits for men with benign prostatic hyperplasia (enlarged prostate) SLACK Incorporated Appoints Simon VP of Meeting and Exhibit Services Clinical Remissions in Three Otherwise Intractable Cancers Signal the Progress of Targeted Genetic Medicine

October 15

Surgeons Discover That Common Anti-Clotting Drug May Cause Problems for Some Trauma Patients NanoBio's Nanoemulsion Kills Drug-Resistant Bacteria Found in Cystic Fibrosis Patients Human Genome Sciences to Host November 2nd Conference Call to Discuss Top-Line Results from Second Phase 3 Trial of Benlysta (Belimumab) in Systemic Lupus Erythematosus KaloBios' KB001 Antibody Shows Encouraging Safety and Activity in New Approach to Fighting Pseudomonas Infection in Cystic Fibrosis Patients Inspire Announces Presentation at the North American Cystic Fibrosis Conference and Provides Enrollment Update for Phase 3 Cystic Fibrosis Trial Protalix BioTherapeutics Announces Positive Top-line Results from its Phase III Clinical Trial of UPLYSO for the Treatment of Gaucher Disease Cardium Reports Positive Data From Matrix Phase 2b Study of Excellarate Topical Gel for Non-Healing Diabetic Foot Ulcers and Plans for Phase 3 Program CREON (pancrelipase) Delayed-Release Capsules Improves Absorption of Fat in Young Children With Cystic Fibrosis

October 19

Angiochem's ANG1005 Demonstrates Safety and Efficacy in Phase 1/2 Brain Cancer Studies Ardea Biosciences Announces Additional Positive Results from a Phase 2a Study of RDEA594 at the 2009 ACR/ARHP Annual Scientific Meeting BENZEFOAM Emollient Foam Demonstrates Significant Reduction in Propionibacterium acnes in Study Presented at the Fall Clinical Dermatology Conference Alnara Pharmaceuticals' Liprotamase Demonstrates Long-Term Safety & Maintenance of Nutritional Status in Patients with CF; Results of Landmark Phase 3 Safety Study Reported Rexahn Reports Positive Top-line Phase IIa Data for Serdaxin in Patients with Major Depressive Disorder (MDD) Study Shows Good Response for New Drug in Patients with Rheumatoid Arthritis Transave Completes Successful Phase II Clinical Program for Arikace in the Treatment of Pseudomonas Lung Infections Trubion Pharmaceuticals, Inc. Reports Positive Data from Phase 2b Re-treatment Study of TRU-015 Northern Light Adds 4,000 Bio-Pharma, Health Sciences and General Business News and Journal Sources from EBSCO Publishing Schering-Plough Highlights Boceprevir, Narlaprevir (SCH 900518) and Pegintron Data at the American Association for the Study of Liver Diseases (AASLD) 2009 Annual Meeting Oxford Biomedica Announces Update On Prosavin Phase I/Ii Trial In Parkinson's Disease And Publication Of Preclinical Results

October 20

Human Genome Sciences and GlaxoSmithKline Announce Full Presentation at ACR of Positive Phase 3 Study Results for Benlysta in Systemic Lupus Erythematosus BioSante Pharmaceuticals Reports Positive LibiGel Safety Data in Phase III Program - Oct 20, 2009 Data Analysis Reinforces the Safety Profile of Levemir New Study Assesses Skin Hydration and Epidermal Function of 2.5% and 5% Benzoyl Peroxide-Clindamycin Combinations Updated Data from Randomized Controlled Phase II Study Evaluating Oral Apremilast in Psoriatic Arthritis Demonstrates Sustained Response at Six Months ORENCIA (abatacept) Demonstrated Sustained Clinical Response in a Study of Adult Patients with Moderate to Severe Early Rheumatoid Arthritis (Less Than Two Years Duration) Calistoga Pharmaceuticals Presents Interim Clinical Efficacy Results from Ongoing Clinical Trial of CAL-101 at the International Workshop on Chronic Lymphocytic Leukemia Idera Pharmaceuticals Presents Preclinical Data at ACR/ARHP 2009 Annual Meeting on IMO-3100, a Toll-Like Receptor Antagonist, in Combination with Enbrel in Arthritis Model Study Results: Novel Oral PTH Formulation Using Emisphere's Eligen Technology Showed Potential Therapeutical Advantages to Available Injectable PTH in Postmenopausal Osteoporotic Women

October 22

Aerie Pharmaceuticals' ROCK Inhibitor, AR-12286, Demonstrates Positive Results in Glaucoma Patients in a Phase 2a Study CombinatoRx'S Synavive (CRx-102) Maintains Efficacy Throughout 12 Month Phase 2 Knee OA Extension Trial Argos Therapeutics Presents Positive Phase 2 Viral Load and Immune Response Data for Arcelis HIV Program at the AIDS Vaccine 2009 Conference Teva Comments on Positive Results of Phase III Trial in MediWound's Debrase AcelRx Announces Positive Results from a Phase 2 Study of ARX-03, a Sufentanil/Triazolam NanoTab for Procedural Sedation, Anxiolysis & Analgesia Medtronic Highlights Positive ONSET Pediatric Diabetes Trial Results Aeolus Drug Protects the Gastrointestinal Tract in Acute Radiation Syndrome Studies Sponsored by the National Institutes of Health's National Institute for Allergy and Infectious Diseases

October 23

Halozyme Study Results Show Faster Insulin Absorption when Administered in Combination with a Wide Range of PH20 Enzyme Concentrations Lubris, Biomodels Report on Potential New Therapy for Osteoarthritis New Data Presented at ACR Meeting Demonstrates Colcrys (Colchicine, USP) Significantly Reduces Pain of Acute Gout Flare Within 24 Hours With Side Effects Comparable to Placebo New Simponi Data Show Inhibition of Joint Damage in Patients With Rheumatoid Arthritis and Psoriatic Arthritis Newly Published Clinical Data Shows Caldolor (Ibuprofen) Injection Reduces Opioid Use While Improving Pain Relief in Post-Operative Patients Patients Taking Vimovo Showed a Decrease in Incidence of NSAID-Associated Ulcers Detailed Results from RV 144 HIV Vaccine Trial Published Today in The New England Journal of Medicine and Presented at the AIDS Vaccine 2009 Conference Provide Insight for Future Research NicOx presents 26 week naproxcinod efficacy data at American College of Rheumatology Novartis drug Tasigna meets primary endpoint in pivotal trial against Gleevec as first-line treatment in chronic myeloid leukemia patients New Phase II data show ACZ885 gave better pain relief and flare prevention for patients with chronic gout than an injectable corticosteroid TransMolecular's 131I-TM601 Shown to Improve Survival in Recurrent Malignant Glioma Exelixis and Bristol-Myers Squibb Report New Phase 2 Data for XL184 in Patients With the Most Common and Aggressive Form of Brain Cancer KYTHERA Biopharmaceuticals Announces Two Data Presentations on Its Novel Fat Reduction Drug at ASPS Meeting TargeGen Announces Successful Completion of Clinical Trial of JAK2 Inhibitor TG101348 in Myelofibrosis Patients Research Into Cancer During Pregnancy: Treating Pregnant Women With Chemotherapy has no Detrimental Effect on the Foetus Bayer and Onyx Initiate Phase 3 Trial of Nexavar in Patients With Non-Responsive Thyroid Cancer Shire Announces New Data on Pharmacokinetics of Vyvanse Interim Clinical Trial Results Show MedImmune's H1N1 Vaccine Has Similar Safety Profile as Seasonal Vaccine in Eligible Children and Adults

October 26

SAGE Launches "Therapeutic Advances in Musculoskeletal Disease" NPS Reports Two Teduglutide Abstracts Accepted for Presentation at American College of Gastroenterology Annual Scientific Meeting Positive Data from Two Investigator-Initiated Studies with Santarus' ZEGERID to Be Presented At ACG "Journal of Primary Care & Community Health" New quarterly journal for 2010 Data Presented On Oncophage Cancer Vaccine In Recurrent Glioma At Sno 2009 Vical's Vaxfectin Adjuvant Drives 200-Fold Increase in Antibody Responses With Sanofi-Pasteur Fluzone Seasonal Influenza Vaccine Theratechnologies: International Workshop on Adverse Drug Reactions and Co-morbidities in HIV Halsa Pharmaceuticals Announces ZAG Demonstrates Weight Loss, Rise in Temperature and Reduction of Diabetes Symptoms in Preclinical Studies at Obesity 2009 Annual Scientific Meeting ImmunoCellular Therapeutics to Present Today Data From Phase I Clinical Trial of ICT-107 at Annual Meeting of Congress of Neurological Surgeons New Study Results Analyzed the Use of Kapidex (dexlansoprazole) for Nighttime Heartburn in Adults with Non-Erosive GERD Horizon Therapeutics Presents Phase 3 Study Results Identifying Risk Factors for Ulcer Development Among NSAID Users Inhibitex Announces Data Presentation at the 60th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) Salix Pharmaceuticals Previews American College of Gastroenterology 2009 Annual Scientific Meeting New Data Presented From WELCOME Trial Show Positive Impact of Cimzia (certolizumab pegol) on Hospitalizations and Surgeries in Patients With Prior Infliximab Failure Data Demonstrate That GATTEX(Teduglutide) Improves Lean Body Mass, Mineral Composition and Electrolyte Levels in Patients with Parenteral Nutrition Dependent Short Bowel Syndrome Creon (pancrelipase) Delayed-Release Capsules Improves Digestive Outcomes In Adults With Chronic Pancreatitis Shire Presents Results of Five Lialda (mesalamine) Analyses at ACG 2009 Annual Scientific Meeting

October 27

Icagen Reports Top-line Results of Phase IIa Study of Senicapoc in Exercise-Induced Asthma New Data From Arena Pharmaceuticals' Pivotal BLOSSOM Trial of Lorcaserin Demonstrate Improvements in Patients' Body Composition, Cardiovascular Risk Factors and Quality of Life Orexigen Therapeutics Releases New Efficacy Data for Contrave(R) in Late Breaker Presentations at the 27th Annual Scientific Meeting of The Obesity Society Phase 2 Data From Oral NKTR-118 Presented at American College of Gastroenterology in San Diego Isotechnika Pharma Announces Voclosporin Presentations at American Academy of Ophthalmology Results of Phase I Study Show Novel, Investigational PA65020 Compound Significantly Decreased Risk of Upper GI Damage in Healthy Adults PolyMedix Completes Successful Phase 1B Clinical Study of Heparin Antagonist PMX-60056 ImmunoCellular Therapeutics Presents Data from Phase I Trial of ICT-107 Demonstrating Significant Increase in Tumor-Free Progression in Patients with Brain Cancer Logical Therapeutics Announces Positive Results of LT-NS001 vs. Naproxen Clinical Study

October 28

Interim Results from Study 107 Highlight the Potential Role of Telaprevir-Based Regimens in HCV Patients Who Failed Prior Treatment New Data Supports Pharmacoeconomic Benefits of Ceplene Intercept Pharmaceuticals Announces Positive Phase II Results for INT-747 as a Treatment for Primary Biliary Cirrhosis Study demonstrates effectiveness of once-daily dose of Asacol for ulcerative colitis Updated European guidelines highlight benefits of Rasilez, the only approved direct renin inhibitor, in treating high blood pressure SCYNEXIS to Present HCV Data on Novel Cyclophilin Inhibitor SCY-635 at AASLD Annual Meeting Forest Laboratories, Inc. and Gedeon Richter Announce Positive Results from a Phase IIb Study of Cariprazine for the Treatment of Schizophrenia Difficult-to-Treat Patient Populations Respond Positively to Hepatitis C Treatment

October 30

YM Biosciences Reports Additional Results From Nimotuzumab Phase III Study In Children With Glioma Presented By Oncoscience Ag Data Presented on Cempra Pharmaceutical's CEM-101 at the Infectious Diseases Society of America Annual Meeting Reinforces Potency and Coverage Against Multidrug-Resistant S. Pneumoniae Isolates Presentations of Cempra Pharmaceutical's CEM-102 (fusidic acid) at the Infectious Diseases Society of America Annual Meeting Highlight Properties That Make It an Excellent Anti-MRSA Candidate Idenix Pharmaceuticals Presents Data on IDX184 for the Treatment of Hepatitis C Virus (HCV) Bayer HealthCare Presents Florbetaben Phase II Study Results at World Congress of Neurology A Decade Later, Lifestyle Changes Or Metformin Still Lower Type 2 Diabetes Risk Inappropriate Initial Antibiotic Treatment May Extend Stays for Patients with Healthcare-Associated Skin Infections Affymax and Takeda Announce Preliminary Phase 2 Data Demonstrated That Hematide Increased Hemoglobin in Dialysis Patients

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