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

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.