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FDA Calendar
May 20-25, Toronto
ANNUAL MEETING OF THE AMERICAN PSYCHIATRIC ASSOCIATION
Includes presentation from Nymox Pharmaceutical Corp. on AlzheimAlert test's successful clinical studies and presentation from Sepracor Inc. on data for Lunesta brand eszopicline for insomnia treatment
May 20-25, Los Angeles
DIGESTIVE DISEASE WEEK CONFERENCE
Includes presentation from Callisto Pharmaceuticals Inc. on Guanilib for gastrointestinal inflammation; presentation from Idenix Pharmaceuticals Inc. on Valopicitabine, a nucleoside polymerase inhibitor for hepatitis C, and presentation from Cytogen Corp. on Prostascint, a diagnostic imaging agent for newly diagnosed patients with biopsy-proven prostate cancer; presentation on antiviral activity of ViroPharma Inc. and Wyeth's HCV-796; presentation from Schering-Plough on hepatitis products that include PEG-INTRON and Rebetol; presentation from Boston Scientific Corp. on Polyflex Esophageal Stent and the Resolution Clip for GI bleeding; and presentation from InterMune Inc. on hepatitis C virus NS3/4A protease inhibitor ITMN-191
May 20-25, Atlanta
2006 ANNUAL MEETING OF THE AMERICAN UROLOGICAL ASSOCIATION
Includes presentation from Matritech on NMP22 BladderChek Test used to identify a molecular marker for cancer in urine and presentation from Cytogen Corp. on Prostascint abstract for prostate cancer
May 21-25, Orlando, Fla.
106th AMERICAN SOCIETY FOR MICROBIOLOGY ANNUAL GENERAL MEETING
Includes presentation from Helix BioMedix Inc. on hexapeptides for bacterial and fungal infections
May 31-June 3, Scottsdale, Ariz.
20th CONSORTIUM OF MULTIPLE SCLEROSIS CENTERS' ANNUAL MEETING
Includes presentation from PharmaFrontiers Corp. on study of patients treated with monovalent T cell therapy
June 1-5, San Francisco
2006 ANNUAL MEETING OF THE FEDERATION OF CLINICAL IMMUNOLOGY SOCIETIES
Includes presentation from PharmaFrontiers Corp. on proprietary T-cell vaccination technology for autoimmune disease multiple sclerosis
June 2, Atlanta
ONCOLOGIC DRUGS ADVISORY COMMITTEE MEETING (FDA)
Committee to provide advice and recommendations to the agency on FDA's regulatory issues, to discuss Bristol-Myers Squibb Co.'s New Drug Application for Sprycel (dasatinib) tablets for the treatment of adults with chronic, accelerated or blast phase chronic myeloid leukemia with resistance or intolerance to prior therapy
June 2-6, Atlanta
2006 AMERICAN SOCIETY OF CLINICAL ONCOLOGY ANNUAL MEETING
Includes presentation from Oncolytics Biotech Inc. on Reolysin clinical trial data, Bioenvision Inc. on Evoltra for adult acute myeloid leukemia; 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 Kosan Biosciences Inc. on phase 1b clinical trials for heat shock protein 90 inhibitor products 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 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 and presentation from Genitope Corp. on phase 2 clinical trial of MyVax for follicular Non-Hodgkine's Lymphoma
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 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 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 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 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, Edinbrugh, U.K.
INTERNATIONAL CONGRESS OF CLINICAL NEUROPHYSIOLOGY
Includes presentation from Nymox Pharmaceutical Corp. on AlzheimAlert, a urine-based diagnostic aid
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