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Published on 6/16/2006 in the Prospect News Biotech Daily.

FDA Calendar

June 17-22, Salt Lake City

20th ANNIVERSARY MEETING OF THE ASSOCIATED PROFESSIONAL SLEEP SOCIETIES

Includes presentation from Sepracor Inc. on data for Lunesta brand eszopiclone for the treatment of insomnia

June 17-22, Scottsdale, Ariz.

ANNUAL MEETING OF THE COLLEGE ON PROBLEMS OF DRUG DEPENDENCE

Includes presentation from New River Pharmaceuticals Inc. on clinical abuse liability studies for NRP104, a compound for ADHD

June 21-24, Amsterdam

EUROPEAN LEAGUE AGAINST RHEUMATISM 2006 ANNUAL CONGRESS

Includes presentation from Savient Pharmaceuticals Inc. on phase 2 trial results for Puricase and presentation from CombinatoRx Inc. on phase 2 trial of CRx-102 for osteoarthritis

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 22-25, Los Angeles

48th ANNUAL AMERICAN HEADACHE SOCIETY MEETING

Includes presentation from Alexza Pharmaceuticals on phase 2a clinical trial for Staccato Prochlorperazine for the acute treatment of migraine headache

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 9-13, Chicago

25th BIENNIAL CONGRESS OF THE COLLEGIUM INTERNATIONALE NEURO-PSYCHOPHARMOCOLOGICUM

Includes presentation from DOV Pharmaceutical Inc. on phase 3 trial of bicifadine in patients with chronic low back pain

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 13-14, Gaithersburg, Md.

PULMONARY-ALLERGY DRUGS ADVISORY COMMITTEE MEETING (FDA)

Includes discussion on the implications of recently available data related to the safety of long-acting beta-agonist bronchodilators and the continued need for the essential use designations of prescription drugs for the treatment of asthma and chronic obstructive pulmonary disease

July 13-15, Greenbelt, Md.

FOOD ADVISORY COMMITTEE MEETING (FDA)

Includes evaluation on the CFSAN Threshold Working Group draft report "Approaches to Establish Thresholds for Major Food Allergens and Gluten" as well as discussion on the draft report's approaches for food allergen thresholds and gluten thresholds

July 15, Gaithersburg, Md.

IMMUNOLOGY DEVICES PANEL OF THE MEDICAL DEVICES ADVISORY COMMITTEE MEETING (FDA)

Committee to hear 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; to discuss, make recommendations and vote on a premarket approval application for a laboratory assay designed to measure levels of neural thread protein in urine specimens from patients presenting with cognitive complaints or other signs and symptoms of suspected Alzheimer's disease

July 23-27, Chicago

AMERICAN ASSOCIATION FOR CLINICAL CHEMISTRY ANNUAL MEETING

Includes presentation by 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. 2-6, Barcelona

WORLD CONGRESS OF CARDIOLOGY 2006

Includes presentation from Vasogen Inc. on phase 3 Acclaim trial of Celacade technology in advanced chronic heart failure

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

Oct. 14-18, Chicago

AMERICAN SOCIETY FOR ANESTHESIOLOGY MEETING

Includes presentation from CeNeS Pharmaceuticals plc on short-acting sedative CNS 7056X for use in the induction and maintenance of anaesthesia


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