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November 2011

November 3

FDA Drug Safety Communication: Safety Review Update of Medications used to Treat Attention-Deficit/Hyperactivity Disorder (ADHD) in Children and Young Adults Obesity Hormone adiponectin Increases the Risk of Osteoporosis in the Elderly Medivation and Astellas Announce Positive Survival Data From Interim Analysis of Phase 3 AFFIRM Trial of MDV3100 in Men With Advanced Prostate Cancer Abbott to Present Broad Spectrum of Compelling Data for HUMIRA (Adalimumab) at American College of Rheumatology Annual Scientific Meeting Phase 3 Study of KALYDECO (ivacaftor) in Children Ages 6 to 11 with a Specific Type of Cystic Fibrosis Showed Significant Improvements in Lung Function and Other Measures of Disease Sustained Through 48 Weeks Researchers Find Anti-depressants Reduce Pain in Opioid-dependent Patients LAVIV (azficel-T) Demonstrates Improvement in Acne Scarring Telik Announces Publication of a Report of Complete Response of G-CSF Resistent Severe Idiopathic Chronic Neutropenia Following Treatment with Telintra(R) Data from the First Part of a Phase 2 Study Support the Approach of Treating the Most Common Form of Cystic Fibrosis (F508del) by Targeting the Underlying Cause of the Disease With a Combination of KALYDECO (ivacaftor) and VX-809 Adolescent Amphetamine use Llinked to Permanent Changes in Brain Function and Behavior TRiUS Data Suggests That Testim Significantly Improved Sexual Function in Hypogonadal Men Exenatide (Byetta) Has Rapid, Powerful Anti-inflammatory Effect, UB Study Shows Statement on Prophylaxis with FEIBA - Study Results Published Today in The New England Journal of Medicine Scientists Prevent Cerebral Palsy-like Brain Damage in Mice Bellicum Announces Publication in The New England Journal of Medicine Demonstrating Complete Reversal of Serious Immune Condition in Hematopoietic Stem Cell Transplant Patients Clinuvel announces positive results of first Phase II US study of SCENESSE® in orphan disease erythropoietic protoporphyria (EPP) miRagen Therapeutics Publishes Data Demonstrating that Therapeutic Dosing of miR-15 Family Inhibitor Protects Against Ischemic Injury to the Heart

November 4

Rexahn Pharmaceuticals Announces Phase II Results for Serdaxin® as Treatment for Major Depressive Disorder Qnexa Phase 3 Data Published In Obesity Show 14.4% Average Weight Loss In Severely Obese Patients Completing One Year Of Treatment RegeneRx Reports Positive Data with RGN-259 in Phase 2 Dry Eye Trial Presidio Pharmaceuticals, Inc. Announces Clinical Proof-of-Concept Data for its First HCV NS5A Inhibitor, PPI-461, and Initiation of Clinical Testing for its Second-Generation NS5A Inhibitor, PPI-668. Study Published in World Journal of Gastroenterology Shows Potential for microRNAs to Predict Gastric Cancer Recurrence RegeneRx Answers Questions Regarding Phase 2 Dry Eye Trial Salix Pharmaceuticals Previews Data Slated for Presentation at 62nd Annual Meeting of the American Association for the Study of Liver Diseases MEDIA ADVISORY: KYTHERA Biopharmaceuticals Announces Preliminary Two-Year Follow-Up Study Results and Poster Presentation of Phase 2B Data from Investigational Fat Reduction Drug at ASDS Taksta (fusidic acid) Demonstrates Activity Against MRSA Isolated From Cystic Fibrosis Patients

November 7

Why Did Healthy Children Fall Critically Ill in the 2009 H1N1 Flu Pandemic? Abbott Announces New Long-Term Data Evaluating Use of Humira (Adalimumab) for Patients with Long-Standing Moderate to Severe Rheumatoid Arthritis and for Patients with Early Moderate to Severe RA Novartis Phase III Study Shows ACZ885 Helped Substantially Reduce Steroid use in 45% of Patients with Serious Form of Childhood Arthritis YM BioSciences to Report Updated Phase I/II Data for CYT387 at ASH 2011 Positive Interim Results from Interferon-Free Phase 2b SOUND-C2 Study with Boehringer Ingelheim's Two Investigational HCV Direct Acting Antivirals Presented at AASLD Regado Biosciences, Inc. Presents Positive Efficacy and Safety Substudy Data from the Phase 2b RADAR Trial for the REG1 Anticoagulation System at the Transcatheter Cardiovascular Therapeutics (TCT) Symposium 2011 New Study Sheds Light on the Challenges of Developing Lupus Treatments Researchers to Present Additional Data on Soliris (eculizumab) as a Treatment for Patients with PNH and aHUS at ASH Annual Meeting First Clinical Study Comparing Pharmacokinetic Profiles of VWF/FVIII Products Published in Medical Journal Studies Show LAVIV (azficel-T) Effectively Improves the Appearance of Smile Line Wrinkles First Clinical Study Comparing Pharmacokinetic Profiles of VWF/FVIII Products Published in Medical Journal Ligand Announces Positive Preclinical Data on IRAK4 Program at the 2011 American College of Rheumatology Annual Scientific Meeting Baxter Presents Phase III HyQ Efficacy and Tolerability Data at American College of Allergy, Asthma & Immunology Meeting KALBITOR (ecallantide) Data in HAE Presented at the American College of Allergy, Asthma and Immunology Annual Meeting Health of Patients with Nonalcoholic Steatohepatitis Improved Through Treatment with Anti-CD3 Antibodies

November 8

NephroGenex Announces the Successful Completion of PYR-210 Novartis Phase III Study Shows ACZ885 Helped Substantially Reduce Steroid Use in 45% of Patients With Serious Form of Childhood Arthritis Abbott Reports Five-Year Data for Humira (Adalimumab) in Ankylosing Spondylitis AstraZeneca and Targacept Announce First Top-Line Phase III Results for TC-5214 As An Adjunct Treatment in Patients With Major Depressive Disorder Toviaz Top-Line Primary Endpoint Results Positive In Overactive Bladder Study Of Nocturnal Urinary Urgency Nabi Biopharmaceuticals Announces Results of Second NicVAX Phase III Clinical Trial Baxter Presents Phase III HyQ Efficacy and Tolerability Data at American College of Allergy, Asthma & Immunology Meeting Phase IIIb Comparison of Baraclude (Entecavir) Monotherapy Versus Baraclude Plus Tenofovir Combination Shows No Statistical Difference Between Study Arms New RAPID 1 Post-Hoc Analysis Showed Early Response to Cimzia (certolizumab pegol) at Week 12 was Predictive of Week 52 Response Phase II Study Evaluating Apremilast as an Oral Treatment for Patients with Ankylosing Spondylitis Presented at ACR Results of two trials show a rapid and sustained response with certolizumab pegol for treatment of rheumatoid arthritis (J-RAPID and HIKARI Studies) released at 2011 meeting of American College of Rheumatology (ACR)

November 9

Bavarian Nordic's Immunotherapy Product Candidate CV-301 Shows Promise in Breast and Ovarian Cancer Cytheris announces interim results from ECLIPSE II Hepatitis C multicenter study of IL-7 in chronically infected genotype one and four nonresponders to standard of care (SOC) Elixir Medical Corporation Announces Excellent Six-Month Safety and Efficacy Results from the EXCELLA BD Randomized Clinical Trial for DESyne BD Novolimus Eluting Coronary Stent with Biodegradable Polymer Sinovac Reports Positive Preliminary Phase II Clinical Trial Results for EV71 Vaccine Against Hand, Foot and Mouth Disease NeuroDerm Announces Positive Results of a Phase II Study of ND0611 Dermal Patch in Patients with Parkinson's Disease Data Published in the Lancet Oncology Support High Efficacy Previously Demonstrated By Cervarix (HPV 16 and 18 Vaccine) Against Precancerous Cervical Lesions Caused By HPV 16 and 18 and Also Efficacy Against Certain Other Cancer-Causing HPV Types Unigene Announces Positive Top-Line Results of Phase 2 Oral PTH Study for the Treatment of Osteoporosis in Postmenopausal Women Cytheris Announces Interim Results from ECLIPSE 2 Hepatitis C Multicenter Study of IL-7 in Chronically Infected Genotype 1 and 4 Nonresponders to Standard of Care (SOC) Medivir's partner Tibotec announced that final SVR24 results from phase IIb PILLAR study of TMC435 will be presented at the AASLD meeting today 12-Week On-Treatment Results from Large Phase IIb Study (COMMAND-1) of Bristol-Myers Squibb's NS5A Inhibitor Daclatasvir Support Anti-HCV Activity and Safety Profile Observed in Earlier Studies ChemoCentryx Reports Clinical Efficacy for CCX354, a Novel CCR1 Inhibitor in a Phase II Study in Patients with Rheumatoid Arthritis BioCryst Pharmaceuticals Presents New BCX4208 Gout Data at the 2011 ACR/ARHP Annual Scientific Meeting Alexza Presents Staccato Loxapine Responder Analyses in Agitated Adult Patients with Schizophrenia or Bipolar Disease at the 2011 USPMHC Annual Conference All-Oral Treatment Regimen of Bristol-Myers Squibb's Investigational NS5A and NS3 Inhibitors Achieved 90% Sustained Virologic Response (SVR12) in Phase II Study Sentinel Cohort of Genotype 1b Null Responders

November 11

KAI Pharmaceuticals Announces Late Breaker Poster Presentation of KAI-4169 Phase 2 Clinical Results at the American Society of Nephrology's Kidney Week 2011 Obese Monkeys Lose Weight on Drug that Attacks Blood Supply of Fat Cells Ablynx Reports Phase Ii Data for Alx-0081 in High Risk Acs Patients Undergoing A Pci Procedure Mesoblast Reports Positive Results Using Intravenously Injected Adult Stem Cells for Type 2 Diabetes Multiple Programs from Merrimack Pharmaceuticals' Pipeline to be Presented at the 2011 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics Boston Scientific SYNERGY Stent Demonstrates Comparable Safety and Effectiveness Outcomes Versus PROMUS Element Platinum Chromium Stent Chimerix Announces Late-Breaking Poster Presentation at Kidney Week 2011 Annual Meeting

November 15

SATURN Demonstrated Effect of Intensive Statin Treatment on Reducing Atherosclerosis Positive Results from POZEN Phase 1 Study (?Co-Rx?) Presented At AHA KAEL-GemVax reports encouraging interim progress in Phase II study of GV1001 anti-telomerase vaccine in NSCLC Abbott Statement on the Results of the AIM-HIGH Study Presented at AHA 2011 ZIOPHARM Oncology Announces Promising Data from Phase 1b Study of Palifosfamide in Small Cell Lung and Other Cancers at AACR-NCI-EORTC Meeting New Medication Increases HDL Cholesterol and Decreases LDL Cholesterol Levels Experimental Drug Safely Boosts Good Cholesterol, Lowers Bad American Heart Association Late-Breaking Clinical Trial Report Niiki Pharma Reports on Synergistic Activity of Novel Anti-Cancer Agent NKP-1339 with Other Anti-Cancer Agents Arrowhead Research Subsidiary Ablaris Therapeutics Data Published in Science Translational Medicine Demonstrates Weight Loss in Obese Monkeys Ampio Pharmaceuticals Announces Positive Results on Ampion Trial for Relief of Nasal Inflammation

November 16

BioSante Pharmaceuticals Announces Positive LibiGel Pharmacokinetic Study Results Gout Drug Reduces Incidence of Irregular Heartbeat After Surgery Synta Presents Results Showing Elesclomol Selectivity in Targeting Cancer Cell Metabolism The Lancet Publishes Results Demonstrating Xgeva Significantly Prolonged Bone Metastasis-free Survival in Men With Prostate Cancer GSK Receives Initial Data From the First Completed Phase Lll Study of Albiglutide in Type 2 Diabetes Increasing Dosage of Clopidogrel For Patients With Genetic Variation Improves Response to Medication NIH Grantees Rebut Theory that Seasonal Flu Strains Originate in Tropical Regions Anavex Successfully Completes a Phase 1 Clinical Trial for ANAVEX 2-73 Tip of the Iceberg: Genetic Screening in Yeast Reveals New Candidate Gene for Lou Gehrig's Disease, Penn Study Finds Idera Announces Presentation on Preclinical Studies of TLR Antagonist Candidate in Models of Atherosclerosis at American Heart Association Scientific Sessions 2011 PharmAthene to Present at the 2011 Chemical and Biological Defense Science and Technology Conference Gencaro Demonstrated 74% Risk Reduction for New Onset Atrial Fibrillation in Heart Failure Patients with Genotype Believed to Be Found in Nearly 50% of Population New Analysis of Data Presented at AHA Regarding Effect of Effient (Prasugrel) on Cardiovascular Events in STEMI Patients According to Timing of PCI Aeterna Zentaris Presents Encouraging Preclinical Data for Disorazol Z (AEZS-137) at AACR-NCI-EORTC Conference Mesoblast Limited (ASX:MSB) Presented Positive Results from Phase 2 Trial of Adult Stem Cell Therapy at the American Heart Association Annual Meeting

November 29

Inhibitex Reports Recent Clinical and Corporate Developments International Stem Cell Corporation to Present Immune Matching Research Advances at Cell Science and Stem Cell Research 2011 Conference Quest PharmaTech Announces Development of Second Generation Photodynamic Therapy Products for the Treatment of Cancer based on Nanotechnology Array Biopharma to Present Clinical Data on ARRY-520, a KSP Inhibitor, and ARRY-614, a Dual p38/Tie2 Inhibitor, at the 2011 American Society of Hematology Annual Meeting Genomic Health Announces Presentation of Sixteen Oncotype DX Studies at the 2011 CTRC-AACR San Antonio Breast Cancer Symposium New Study Points to Novel Mechanism by Which Tumors Escape Recognition by the Immune System The 11th Colloque Médecine et Recherche of the Fondation Ipsen in the Endocrinology series: ?Multiple origins of sex differences in brain. Neuroendocrine functions and their pathologies.? News from the 97th Scientific Assembly and Annual Meeting of the Radiological Society of North America (RSNA) in Chicago Growth Hormone Increases Bone Formation in Obese Women The Majority of Gout Patients on Uric Acid Lowering Therapy Fail to Achieve Control of Serum Urate Levels Despite the Availability of Newer Treatment Options Such as Takeda's Uloric, Menarini/Ipsen's Adenuric and Savient Pharmaceuticals' Krystexxa

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