FDA Calendar

June 2-6, Atlanta

2006 AMERICAN SOCIETY OF CLINICAL ONCOLOGY ANNUAL MEETING

Includes presentation from Sanofi-aventis US on Eloxatin and Taxotere; presentation from Immunicon Corp. on its cellular analysis of circulating tumor cells in patients with metastatic breast cancer; presentation from Oncolytics Biotech Inc. on Reolysin clinical trial data, Bioenvision Inc. on Evoltra for adult acute myeloid leukemia; presentation from Metabasis Therapeutics Inc. on phase 1/ 2 study for MB07133 for unresectable hepatocellular carcinoma; presentation from Cytogen Corp. on Quadramet for multiple myeloma and Cell Genesys Inc. on trial of GM-CSF-gene transduced allogeneic prostate cancer cellular immunotherapy with human anti-CTLA-4 antibody for hormone-refractory prostate cancer and K562/GM-CSF vaccination for tumor burden related to chronic myelogenous leukemia; presentations from ChondroGene Ltd. on use of blood biomarkers to detect colorectal cancer and prostate cancer; presentation from Antisoma plc on phase 2 study of AS1404 for lung cancer and ovarian cancer as well as the phase 1 study of R1550 for breast cancer; presentation from Pfizer Inc. on Sutent phase 3 results in gastrointestinal stromal tumors; presentation from Genomic Health Inc. on gene expression profiles in formalin-fixed, paraffin-embedded core biopsies and tumor gene expression; presentation from Kosan Biosciences Inc. on phase 1b clinical trials for heat shock protein 90 inhibitor product candidate KOS-953 for metastatic breast cancer and phase 1 trials for intravenous KOS-1022 for second-generation Hsp90 inhibitor for patients with advanced hematological malignancies; presentation from Cytogen Corp. on phase 1 study of bortezomib and 153Sm-lexidronam combination for refractory and relapsed multiple myeloma; presentation from Pharmacyclics Inc. on phase 3 study of neurologic progression with motexafin gadolinium and radiation therapy; presentation from Lorus Therapeutics Inc. on phase 3 trial of Virulizin plus gemcitabine in pancreatic cancer and phase 1 study of GTI-2040, an antisense to ribonucleotide reductase; presentation from GlaxoSmithKline on data from Tykerp in trastuzumab-resistant breast cancer and phase 2 results for Tykerb in monotherapy in patients with relapsed/refactory inflammatory breast cancer; presentation from Pharmacyclics Inc. on Xcytrin injection and phase 3 Smart study; presentation from Cell Therapeutics Inc. on Xyotax, pixantrone and CT-2106 for non-Hodgkin's lymphoma; presentation from Sunesis Pharmaceuticals Inc. on phase 1 studies for SNS-595; presentation from MethylGene Inc. on trials for MGCD0103 for leukemia or myelodysplastic syndromes and presentation from Genitope Corp. on phase 2 clinical trial of MyVax for follicular Non-Hodgkin's lymphoma; presentation from Genta Inc. on abstracts for Genasense injection, an anticancer compound; presentation from Hana Biosciences on phase 1 trials for Talotrexin for relapsed or refactory non-small cell lung cancer and Zensana oral spray; presentation from OSI Pharmaceuticals Inc. on Tarceva; presentation from Adventrx Pharmaceuticals Inc. on phase 2 CoFactor trials; presentation from SkyePharma plc on DepoCyt for neoplastic meningitis; and presentations from Millennium Pharmaceuticals Inc. on Velcade for multiple myeloma, non-hodgkin's lymphoma, non-small cell lung cancer, relapsed or refractory mantle cell lymphoma and Waldenstrom's macroglubulinemia

June 3-7, San Diego

53rd ANNUAL MEETING OF THE SOCIETY OF NUCLEAR MEDICINE

Includes presentation from Immunomedics Inc. on a new platform technology for producing multifunctional binary fusion proteins

June 6, Rockville, Md.

PULMONARY-ALLERGY DRUGS ADVISORY COMMITTEE MEETING (FDA)

Committee to consider safety and efficacy of New Drug Application 50-799, proposed trade name Pulminiq (cyclosporine, inhalation solution) from Chiron Corp., for use in combination with standard immunosuppressive therapy to increase survival and prevent chronic rejection in patients receiving allogenic lung transplants

June 7-9, San Francisco

INTERNATIONAL SOCIETY OF MINIMALLY INVASIVE CARDIOTHORACIC SURGERY ANNUAL MEETING

Includes presentation from Cardica Inc. on its C-Port Distal Anastomosis System and PAS-Port Proximal Anastomsis System

June 8, Gaithersburg, Md.

GASTROENTEROLOGY AND UROLOGY 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; committee to discuss and make recommendations regarding general issues related to the premarket requirements for the safe and effective use of hemodialysis equipment labeled for nocturnal hemodialysis therapies

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 and presentation from DexCom Inc. on abstracts for its STS continuous glucose monitor

June 10, Rockville, Md.

ADVISORY COMMITTEE ON SPECIAL STUDIES RELATING TO THE POSSIBLE LONG-TERM HEALTH EFFECTS OF PHENOXY HERBICIDES AND CONTAMINANTS (RANCH HAND ADVISORY COMMITTEE, FDA)

Committee to discuss updates on research and reports from the National Academy of Sciences (NAS) on the NAS Disposition Study; April 14 public workshop regarding the NAS Disposition Study; possibility of a comprehensive study report derived from the Air Force Health Study (AFHS); research updates on AFHS activities

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 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

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, U.K.

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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