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Food & Drug Law Weekly


Susan Hasty, Publisher
Table of Contents . . . June 19th, 2009
Non-Subscriber - Summaries Only
Related Areas: Other Issues in Food & Drug Law Weekly | Other Publications

American Chemistry Council - California Senate Ignores Worldwide Body of Scientific Evidence and Votes to Limit Consumer Choice

Heart Attack - Avandia Attorney Says Study Based on 'Useless Trick Science'

Pediatrics - LCA Applauds Senate Leadership Team Working to Secure New FDA Regulatory Authority Over Tobacco

Unigene Laboratories, Inc. - Unigene Draws Down Remaining $5 Million from Non-Convertible Debt Financing

Abraxis BioScience, Inc. - New Study Results Published Compare ABRAXANE® to Taxotere®

Advanced Life Sciences Holdings, Inc. - Advanced Life Sciences Announces Outcome of FDA's Anti-Infective Drugs Advisory Committee Review of Restanza cethromycin

Albany Molecular Research, Inc. - AMRI Advances New Obesity Treatment Toward IND Submission

Allergies - ISTA Pharmaceuticals Announces FDA Advisory Committee to Review Bepreve(TM) for the Treatment of Ocular Itching Associated with Allergic Conjunctivitis

American Chemistry Council - American Chemistry Council Welcomes Call for Expedited FDA Review of BPA

American Gastroenterological Association - NOTES advances suggest promising future for scarless surgery

Amyotrophic Lateral Sclerosis - AIMSPRO is Awarded TGA Orphan Status for the Treatment of Amyotrophic Lateral Sclerosis

Anti-Infectives - B. Braun Anticipates Becoming First to Deliver FDA Approved 2g Cefazolin

ARCA biopharma, Inc. - ARCA biopharma Receives Complete Response Letter From FDA on the GencaroTM NDA

Arthritis - ACTEMRA(R) (tocilizumab) Studies to be Featured at the European League Against Rheumatism (EULAR) Congress

Asymchem Laboratories, Inc. - Asymchem Announces sFDA Certification for Drug Product Manufacturing

Attention Deficit Hyperactivity Disorder - FDA Approves Labeling Change for VYVANSE(R) (lisdexamfetamine dimesylate) CII to Include Supplementary Clinical Data Supporting Efficacy at 13 Hours Postdose in Children Aged 6 to 12 with ADHD

Biologics - American Academy of Dermatology Issues New Guidelines for the Management of Psoriasis With Systemic Medications

Biologics - ViroPharma Receives Complete Response Letter for Cinryze(TM) Supplemental Biologics License Application for Acute Treatment of Hereditary Angioedema

BioMed Central - Antibiotic-resistant bacteria found in fertilizer

Biotech Business - Covance Announces Monte Jarvis as Vice President of Global Data Management and Biostatistics for Periapproval Services

BioTrends Research Group, Inc. - Once Monthly Dosing: How Much of a Competitive Advantage is it? Rheumatologists Provide Insight in the Baseline Report of LaunchTrends(TM): SIMPONI(TM)

Biowarfare - Study findings from Linkoping University provide new insights into biowarfare

Bird Flu - Study to Investigate AHCC and the Swine Flu Virus

Breast Cancer Screening - New breast cancer screening study findings reported from St. Bartholomew's Hospital

Cancer Vaccines - Research from J. Bornstein and colleagues has provided new data on cancer vaccines

Cardiovascular Disease - Quest Diagnostics HemoCue AB Subsidiary to Add Avie(TM) Hemoglobin A1c to Diabetes Point-of-Care Test Suite

Cell Therapeutics, Inc. - Pixantrone Significantly Increases Complete Remissions, Overall Response Rates, Frequency of Durable Remissions and Progression Free Survival in Patients with Relapsed and Refractory Aggressive Non-Hodgkin's Lymph

Clinical Data - Clinical Data, Inc. Announces Positive Results from Second Phase III Trial of Vilazodone for Depression

Clinical Trial Research - Findings from Baylor College of Medicine, College of Medicine broaden understanding of clinical trial research

Columbia University's Mailman School of Public Health - New arenavirus discovered as cause of hemorrhagic fever outbreak in South Africa and Zambia

Crohn Disease - New Crohn disease study results from University of Milan described

Crohn Disease - New One-Year Data from REMICADE(R) SONIC Trial Show Sustained Efficacy Compared with Azathioprine in Treatment of Crohn's Disease

Cystinosis - Raptor Pharmaceuticals Doses First Patient in Phase 2b Clinical Trial of DR Cysteamine for Cystinosis

Dengue Fever - New dengue fever data have been reported by M.A. Johansson and co-authors

Dengue Fever - Research conducted at University of Malaysia has provided new information about dengue fever

Dengue Fever - Studies by L.E. Yauch and co-authors describe new findings in dengue fever

Dengue Fever - Study results from S. Vejbaesya et al provide new insights into dengue fever

Diabetes Management - Bayer Diabetes Care Launches A1CNow(R) SELFCHECK, a New A1C Monitor for At-Home Use

Diagnostics - Study findings from H. Tronel et al broaden understanding of diagnostics

Drug Delivery - CenterSpan Announces Acquisition of New Drug Delivery System

Drug Development - Cordex Receives Special Protocol Assessment Approval from FDA for ATPace(TM)

Drug Resistance - Researchers from Department of Agriculture discuss findings in drug resistance

DSM Biomedical - DSM Biomedical proprietary polymers help customers, AxioMed and Sunshine Heart, reach commercial and clinical success

Dyslipidemias - Abbott and AstraZeneca Submit New Drug Application to the FDA for CERTRIAD(TM), an Investigational Treatment for Mixed Dyslipidemia

Eclipsys Corporation - Sunnybrook Health Sciences Centre Chooses Eclipsys’ Sunrise Patient Flow

Epilepsy - FDA Approves Lamictal(R)XR(TM); an Extended-Release Once-Daily, New Generation Treatment for Epilepsy

EQ Labs, Inc. - EQ Smart Energy Brand Goes International

Escherichia Coli - New findings from A.V. Semenov and co-authors describe advances in Escherichia coli

Escherichia Coli - Study results from M. Steele and colleagues update understanding of Escherichia coli

Esophageal Cancer - Paclitaxel Poliglumex (OPAXIO(TM)) Added to Cisplatin and Radiation Produces 45% Pathologic Complete Remissions in Patients With Esophageal Cancer

Gene Therapy - PARI Pharma Reports Successful Phase Ib Clinical Results for Inhaled Liposomal Cyclosporine a and Gains FDA Orphan Drug Designation for the Prevention and Treatment of Bronchiolitis Obliterans

Genentech, Inc. - Avastin Plus Commonly Used Chemotherapies Improved Progression-Free Survival in Advanced Breast Cancer

Genzyme Corp. - Genzyme Completes Transaction with Bayer HealthCare

Gilead Sciences, Inc. - Gilead Sciences’ Marketing Authorisation Application for Regadenoson Validated by European Medicines Agency

Gloucester Pharmaceuticals - Gloucester Pharmaceuticals Presents Positive Clinical Data for Romidepsin in CTCL and Further Preclinical Evidence of Synergism with Bortezomib at ASCO

Gloucester Pharmaceuticals - Gloucester Pharmaceuticals to Present New Data from Two Studies on Romidepsin at ASCO

Head and Neck Cancer - Researchers at the Karmanos Cancer Institute in Detroit Discover Feasibility of Chemotherapy Alternative

HIV/AIDS - New findings reported from Massachusetts General Hospital describe advances in HIV/AIDS

IDEAL IMPLANT - New Breast Implant Designed as Alternative to Silicone Gel

IDEAL LIFE, INC. - IDEAL LIFE® and Bayada Nurses Reduce Hospitalizations by 40-60 Percent for Patients with Congestive Heart Failure CHF and Hypertension

Incyte Corporation - Incyte Provides Update on Special Protocol Assessment for INCB18424 as a New Treatment for Myelofibrosis

Influenza - China's Vice Premier, Li Keqiang, Visits Sinovac to Inspect H1N1 Vaccine Production Preparation

Innovia Llc - Innovia Receives FDA Clearance for the InnoPort(TM)

International Serious Adverse Events Consortium - International Serious Adverse Events Consortium announces initial study results in its global research collaboration to identify genetic markers related to drug induced liver injury

Intracranial Hemorrhages - Researchers from University Hospital detail new studies and findings in the area of intracranial hemorrhages

JAMA and Archives Journals - Antidepressant does not stop repetitive behaviors in autistic children

JAMA and Archives Journals - FDA warnings led to unintended changes in depression diagnosis

Kamada - Kamada Submits U.S. Biologics License Application for the First Liquid, Ready to Use AAT for the Treatment of Alpha-1 Antitrypsin Deficiency

KARL STORZ Endoscopy-America, Inc. - KARL STORZ Announces Endorsement of the STERRAD® NX™ & STERRAD® 100NX™ Systems from ASP for Its Flexible Fiberscopes

Lantheus Medical Imaging, Inc. - Lantheus Medical Imaging, Inc. Completes Enrollment of CaRES Registry to Further Evaluate DEFINITY® in Patients with Suboptimal Echocardiograms

Legionnaire Disease - Research from National Cheng-Kung University, Medical Department in the area of legionnaire disease published

Leukemia - FDA Advisory Panel Makes Favorable Recommendation for GlaxoSmithKline and Genmab's ARZERRA(TM) (ofatumumab)

Life Sciences - Data on life sciences reported by A.R. Kore and co-researchers

Life Sciences - Data on life sciences reported by G. Thorpe and co-researchers

Life Sciences - Findings in life sciences reported from T.K. Hamilton and co-researchers

Life Sciences - Recent findings in life sciences described by A. Alonsogarbayo and colleagues

Life Sciences - Research from G. Maluenda and co-authors in the area of life sciences published

Life Sciences - Semmelweis University reports research in life sciences

Life Sciences - Studies from L.J. Jansky et al provide new data on life sciences

Mental Illness - Study data from King's College London, Division of Psychological Medicine update understanding of mental illness

Merck KGaA - Merck KGaA: Follow-Up From Stimuvax Study Provides Long-Term Safety Data In Advanced Lung Cancer Patients Receiving Treatment for Up To 8.2 Years

Merge Healthcare Incorporated - Merge Healthcare Announces Definitive Agreement with etrials Worldwide

Molex Incorporated - Molex Honored as a Supplier to the NeuroStar TMS Therapy System for the 2009 Medical Design Excellence Awards

Monterey Mushrooms - Monterey Mushrooms Launches Vitamin D Enriched Sun Grill-A-Bella and White Mushrooms

Neuroendocrine Cancer - Delcath Systems Granted Third Orphan Drug Designation

Non-Small Cell Lung Cancer - ALIMTA(R) (pemetrexed for injection) Receives Positive Opinion From CHMP as Maintenance Therapy for Nonsquamous Non-Small Cell Lung Cancer

Obstructive Sleep Apnea - Research on obstructive sleep apnea described by scientists at University Hospital

Ortho-McNeil - FDA Issues Complete Response Letter for Rivaroxaban

Osteoarthritis - Lilly Resubmits Cymbalta(R) Supplemental New Drug Application for Chronic Pain to U.S. Food and Drug Administration

Osteoporosis - FDA Approves Reclast(R) to Prevent Osteoporosis in Postmenopausal Women With Convenient Less Frequent Dosing

Parkinson Disease - New Parkinson disease study findings have been reported by S. Howell and colleagues

Pharmaceuticals - New findings from University of Southern Denmark, Institute of Public Health in the area of pharmaceuticals published

Pharmaceuticals - New pharmaceuticals research from J.E. Henningfield and co-researchers described

Pharmaceuticals - PharmAthene Submits Proposal to BARDA in Response to Broad Agency Announcement for Advanced Research and Development for Valortim(R)

Plague - Data from M. Rajerison and colleagues advance knowledge in plague

Plague - Reports summarize plague research from J.V. Rogers and co-authors

PRTM - Dr. Robert P. Kadlec Returns to PRTM Following White House Biological Defense Policy Appointment

PureCircle - Supply Chain Investment Key to Stevia's Competitiveness

QIAGEN - QIAGEN to Supply Molecular Screening Solutions to Increase Safety of Blood Donations in Brazil

Regulatory Actions - Reports outline regulatory actions study findings from J. Buchan and colleagues

Regulatory Actions - Research reports on regulatory actions from University of Washington provide new insights

Regulatory Actions - XTENT, Inc. Receives Conditional Approval for Investigational Device Exemption of Custom NX(R) Drug Eluting Stent System from United States Food and Drug Administration

Regulatory Affairs Professionals Society (RAPS) - FDA Commissioner Hamburg to Deliver Keynote at RAPS Conference

Roche Diagnostics - The 454 Genome Sequencing System Detects a Novel Virus Responsible for South African Hemorrhagic Fever Outbreak

Rogaine - Celebrity Hairstylist Thom Priano Named Official Stylist for the ROGAINE Brand

SAGE Publications - FDA ignores critical information on home HIV tests

Schering-Plough Corporation - Schering-Plough Announces European Filing of SYCREST asenapine for the Treatment of Schizophrenia and Bipolar I Disorder

Seattle Genetics, Inc. - Seattle Genetics Reports Data from a Weekly Dosing Phase I Clinical Trial of SGN-35 in Lymphoma

Sepracor Inc. - Sepracor’s STEDESA™ Eslicarbazepine Acetate New Drug Application Formally Accepted for Review by the FDA

Small Bone Innovations, Inc. - FDA Approves SBi’s S.T.A.R.® Total Ankle Replacement System

Spectrum Pharmaceuticals, Inc. - Spectrum Pharmaceuticals Receives $20 Million from Three Institutional Investors at $5.11 Per Share

Surgical Technology - Ethicon Endo-Surgery Studies Presented at DDW Demonstrate Potential of Pure NOTES Surgery With Company's Toolbox

Takeda Pharmaceutical Company Limited - Takeda to Revise Timing of Alogliptin and Alogliptin/ACTOS MAA Filings in Europe

Thrombocytopenia Prevention - Findings from M.J. Hursting and co-authors provide new insights into thrombocytopenia prevention

Thrombophilia - Cepheid Receives Health Canada License for Xpert(R) HemosIL(R) FII & FV Test

Tick-Borne Encephalitis - New tick-borne encephalitis study findings have been published by K. Ellencrona and colleagues

Transoma Medical, Inc. - Transoma Medical Receives FDA Marketing Clearance for Exclusive Capability Providing Immediate Access to Critical ECGs on Mobile Handheld Device

Ulcerative Colitis - Shire Presented Results of a New Database Analysis on Lialda(R) (Mesalamine) and Other 5-ASAs for Ulcerative Colitis at Digestive Disease Week

Washington University School of Medicine - Drug's epilepsy-prevention effect may be widely applicable

West Nile Virus - Findings from Rutgers University advance knowledge in west nile virus

West Nile Virus - Studies from Utah State University update current data on west nile virus

ZIOPHARM Oncology, Inc. - ZIOPHARM Presents Positive Darinaparsin Clinical Data at ASCO’s Prestigious Clinical Science Symposium



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