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FDA Calendar
June 9-13, Washington, D.C.
AMERICAN DIABETIC ASSOCIATION ANNUAL SCIENTIFIC SESSION
Includes presentation from Medicure Inc. on phase 2 Matched study with MC-4232 for metabolic function in hypertensive diabetic patients; presentation from Amylin Pharmaceuticals Inc. on Byetta injection and Symlin injection focused on the use of incretin hormones for type 2 diabetes; presentation from ChemGenex Pharmaceuticals on new data for Psarl gene; and presentation from DexCom Inc. on abstracts for its STS continuous glucose monitor
June 12-15, Boca Raton, Fla.
46th ANNUAL NEW CLINICAL DRUG EVALUATION UNIT MEETING
Includes presentation from Predix Pharmaceuticals on phase 2 data for PRX-00023 for generalized anxiety disorder
June 15-16, Gaithersburg, Md.
CARDIOVASCULAR AND RENAL DRUGS ADVISORY COMMITTEE MEETING (FDA)
Includes discussion on class labeling of antihypertensive drugs based on the proximity of their data to outcome trials as well as discussion on New Drug Application 20-727, proposed trade name Bidil (hydralazine hydrochloride/isosorbide dinitrate) Tablets, from NitroMed Inc. for the indication of heart failure, based on the results from the African American Heart Failure Trial
June 15-17, Bologna, Italy
4th BOLOGNA INTERNATIONAL MEETING ON AFFECTIVE, BEHAVIORAL AND COGNITIVE DISORDERS IN THE ELDERLY
Includes presentation from Nymox Pharmaceutical Corp. on clinical results for AlzheimAlert test, a urine-based test
June 15-17, Stockholm
6th INTERNATIONAL CONFERENCE ON THE ADJUVANT THERAPY OF MALIGNANT MELANOMA
Includes presentation from Viragen Inc. on Multiferon as a first-line adjuvant treatment of malignant melanoma following dacarbazine after surgical removal of tumors
June 15-18, Amsterdam
11th CONGRESS OF THE EUROPEAN HEMATOLOGY ASSOCIATION
Includes presentation from Alexion Pharmaceuticals Inc. on phase 3 trial of eculizumab for paroxysmal nocturnal hemoglobinuria and presentation from Micromet Inc. on phase 1 trial for MT103 to treat certain types of B-cell lymphomas
June 17, Gaithersburg, Md.
NEUROLOGICAL DEVICES PANEL OF THE MEDICAL DEVICES ADVISORY COMMITTEE MEETING (FDA)
Committee to hear a presentation on the FDA Critical Path Initiative and a presentation by the Office of Surveillance and Biometrics in the Center for Devices and Radiological Health outlining their responsibility for the review of postmarket study design as well as an update on the status of recent devices brought before the committee; committee to discuss, make recommendations and vote on a premarket approval application for a selective head cooling system intended for use in infants 36 weeks of gestation or older at risk for moderate to severe hypoxic-ischemic encephalopathy (HIE) to prevent or reduce the severity of HIE
June 21-24, Amsterdam
EUROPEAN LEAGUE AGAINST RHEUMATISM 2006 ANNUAL CONGRESS
Includes presentation from Savient Pharmaceuticals Inc. on phase 2 trial results for Puricase
June 21-23, Toulon, France
14TH INTERNATIONAL SYMPOSIUM ON HIV AND EMERGING INFECTIOUS DISEASES
Includes presentation from Adventrx Pharmaceuticals Inc. on antiviral activity of Thiovir
June 22-23, Gaithersburg, Md.
CIRCULATORY SYSTEM DEVICES PANEL OF THE MEDICAL DEVICES ADVISORY COMMITTEE MEETING (FDA)
Committee to discuss, make recommendations and vote on a premarket approval application for a cardiac device intended to treat patients with heart failure as well as humanitarian device exemption for an artificial heart
June 23, Giathersburg, Md.
OBSTETRICS AND GYNECOLOGY DEVICES PANEL OF THE MEDICAL DEVICES ADVISORY COMMITTEE MEETING (FDA)
Committee to hear a presentation on the FDA Critical Path Initiative; to discuss, make recommendations and vote on a premarket approval application for a fetal heart monitoring device that, in addition to standard features, is used during labor and delivery to measure, display and analyze the ST waveform of the fetal electrocardiogram
June 24-27, Boston
THE ENDOCRINE SOCIETY'S 88th ANNUAL MEETING
Includes presentation from Manhattan Pharmaceuticals Inc. on effect of chronic or intermittent oral administration of Oleoyl-estrone on food intake, body weight and body composition in normal rats
June 28, Rockville, Md.
PEDIATRIC ETHICS SUBCOMMITTEE OF THE PEDIATRIC ADVISORY COMMITTEE MEETING (FDA)
Committee to discuss a referral by an Institutional Review Board of a proposed clinical investigation that involves both an FDA regulated product and research involving children as subjects that may be supported by HHS titled "Precursor Preference in Surfactant Synthesis of Newborns"
June 29-30, Rockville, Md.
PEDIATRIC ADVISORY COMMITTEE MEETING (FDA)
Committee to hear and discuss the recommendation of the Pediatric Ethics Subcommittee regarding a referral by an Institution Review Board of a proposed clinical investigation involving children as subjects that is regulated by FDA and is conducted or supported by DHHS; to discuss a report by the agency on Adverse Event Reporting for ethinyl estradiol; norgestimate (Ortho Tri-Cyclen), ciprofloxacin (Cipro), tolterodine (Detrol LA), leflunomide (Arave), paricalcitol (Zemplar), zolmitriptan (Zomig), dorzolamide Trusopt
July 12-15, Washington
13th WORLD CONFERENCE ON TOBACCO OR HEALTH
Includes presentation from Nymox Pharmaceutical Corp. on results for saliva NicAlert test for tobacco exposure
July 23-27, Chicago
AMERICAN ASSOCIATION FOR CLINICAL CHEMISTRY ANNUAL MEETING
Includes presentation for PreMD Inc. on abstract for microwell-based format of LungAlert for lung cancer
July 27-28, Tyson's Corner, Va.
2nd ANNUAL OBESITY DRUG DEVELOPMENT SUMMIT
Includes presentation from Manhattan Pharmaceuticals Inc. on oral Oleoyl-estrone for obesity
Sept. 3-8, Sydney, Australia
10th INTERNATIONAL CONGRESS ON OBESITY
Includes presentation from Manhattan Pharmaceuticals Inc. on long-term treatment of zucker obese rats with Oleoyl-estrone to decrease expression of pro-inflammation markers in white adipose tissue
Sept. 10-14, Edinburgh, Scotland
INTERNATIONAL CONGRESS OF CLINICAL NEUROPHYSIOLOGY
Includes presentation from Nymox Pharmaceutical Corp. on AlzheimAlert, a urine-based diagnostic aid
Sept. 14-17, Copenhagen
42nd EUROPEAN ASSOCIATION FOR THE STUDY OF DIABETES CONFERENCE
Includes presentation from CeNeS Pharmaceuticals plc on CNS 5161, a neuronal glutamate receptor antagonist
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