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Published on 3/6/2006 in the Prospect News Biotech Daily.

FDA Calendar

March 3-7, San Francisco

64th ANNUAL AMERICAN ACADEMY OF DERMATOLOGY CONFERENCE

Includes presentation from Advitech Inc. subsidiary PhotoMedex Inc. on Dermylex for plaque psoriasis, Connetics Corp. on Desilux, Primolux and Soriatane for atopic dermatitis, Isotechnika Inc. on phase 3 trials of ISA247, a calcineurin inhibitor, and 3M Pharmaceuticals on Aldara cram for actinic keratosis, superficial basal cell carcinoma, external genital warts

March 3-8, Miami

ANNUAL MEETING OF THE AMERICAN ACADEMY OF ALLERGY, ASTHMA AND IMMUNOLOGY

Includes presentation from Dynavax Technologies Corp. on phase 2/3 clinical trials for Tolamba, a ragweed immunotherapeutic

March 9-11, Lisbon, Portugal

INTERNATIONAL SOCIETY FOR THE STUDY OF WOMEN'S SEXUAL HEALTH CONFERENCE

Includes presentation from BioSante Pharmaceuticals Inc. on Bio-E-Gel, a transdermal estradiol gel for postmenopausal vasomotor symptoms

March 11, Gaithersburg, Md.

ANTIVIRAL DRUGS ADVISORY COMMITTEE (FDA)

Committee to discuss New Drug Applications 21-797 for entecavir tablets and 21-798 for entecavir oral solution from Bristol-Myers Squibb Co. for chronic hepatitis B infection

March 11-14, Atlanta

55th ANNUAL SCIENTIFIC SESSION OF THE AMERICAN COLLEGE OF CARDIOLOGY

Includes presentation from Vasogen Inc. on phase 3 Simpadico trial in peripheral arterial disease; presentation related to BioMarin Pharmaceutical Inc.'s use of tetrahydrobiopterin cofactor as a antihypertensive therapy

March 15, Bethesda, Md.

VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE (FDA)

Committee to review safety and immunogenicity for two tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, absorbed vaccines from GlaxoSmithKline Biologicals and Aventis Pasteur Ltd.

March 16-19, Dallas

ANNUAL SYMPOSIUM OF THE AMERICAN MEDICAL DIRECTORS ASSOCIATION

Includes presentation from Nymox Pharmaceutical Corp. on clinical study data for AlzheimAlert, a urine-based diagnostic aid for Alzheimer's disease

March 17, Gaithersburg, Md.

CIRCULATORY SYSTEM DEVICES PANEL OF THE MEDICAL DEVICES ADVISORY COMMITTEE (FDA)

Committee to discuss and make recommendations on premarket notification submission for use in the induction, maintenance and reversal of mild hypothermia in the treatment of unconscious adult patients with spontaneous circulation after out-of-hospital cardiac arrest when initial rhythm was ventricular fibrillation

March 17-18, Gaithersburg, Md.

BLOOD PRODUCTS ADVISORY COMMITTEE (FDA)

Committee to hear updates on summary of Department of Health and Human Services Advisory Committee on Blood Safety and Availability meeting; summary of the Transmissible Spongiform Encephalopathies Advisory Committee meeting; update on West Nile Virus guidance; summaries of the Critical Path Initiative workshop; recommendations on the safety of albumin; updates on international agreements and a presentation on sharing information with the public

March 23, Gaithersburg, Md.

NONPRESCRIPTION DRUGS ADVISORY COMMITTEE (FDA)

Committee to discuss microbiologic surrogate endpoints used to demonstrate effectiveness of antiseptic products used in health care settings

March 24, Gaithersburg, Md.

JOINT MEETING OF THE DERMATOLOGIC AND OPHTHALMIC DRUGS ADVISORY COMMITTEE AND THE NONPRESCRIPTION DRUGS ADVISORY COMMITTEE (FDA)

Committee to discuss necessary and sufficient safety database to evaluate prescription to over-the-counter switch of topical corticosteroids, particularly for the potential of hypothalamic, pituitary, adrenal and growth suppression

April 1-5, Washington

2006 AMERICAN ASSOCIATION FOR CANCER RESEARCH ANNUAL MEETING

Includes presentation from Ariad Pharmaceuticals Inc. on development pipeline and AP23573 for soft-tissue and bone sarcomas; presentation from Chemokine Therapeutics Corp. on preclinical study of CTCR-9908 anticancer compound in prostate cancer model and presentation from Oncolytics Biotech Inc. on phase 1 combination Reolysin/radiation clinical trial results

April 1-8, San Diego

58th AMERICAN ACADEMY OF NEUROLOGY ANNUAL MEETING

Includes presentation from CepTor Corp. on abstract for Myodur calpain inhibitor for Duchenne Muscular Dystrophy

April 6-8, Mannheim, Germany

EORTC SOFT TISSUE AND BONE SARCOMA GROUP MEETING

Includes presentation from Ariad Pharmaceuticals Inc. on development pipeline and AP23573 for soft-tissue and bone sarcomas

April 7, Bethesda, Md.

ALLERGENIC PRODUCTS ADVISORY COMMITTEE MEETING (FDA)

Includes discussion on proposed strategy for reclassification of class IIIA allergenic products, update of the FDA critical path initiative

April 11-13, Gaithersburg, Md.

GENERAL AND PLASTIC SURGERY DEVICES PANEL OF THE MEDICAL DEVICES ADVISORY COMMITTEE (FDA)

Includes oral presentations from public, discussion, recommendations and vote on two premarket approval applications for silicone gel-filled breast prostheses

April 15, Rockville, Md.

SCIENCE BOARD TO THE FOOD AND DRUG ADMINISTRATION MEETING

Discussion and presentation on agency's pre- and post-marketing safety programs for drugs and biologics and good manufacturing practices for vaccines, blood and cell, tissue and gene products

April 19-22, Geneva, Switzerland

9th INTERNATIONAL GENEVA/SPRINGFIELD SYMPOSIUM ON ADVANCES IN ALZHEIMER THERAPY

Includes presentations from Axonyx Inc. on Phenserine and Posiphen

April 22, Gaithersburg, Md.

CIRCULATORY SYSTEM DEVICES PANEL OF THE MEDICAL DEVICES ADVISORY COMMITTEE (FDA)

Includes presentation by the Office of Surveillance and Biometrics on its review of post-market study design, update on recently purchased devices, recommendations on premarket notification submission for coronary proximal anastomosis device

April 26-30, Vienna, Austria

41st ANNUAL MEETING OF THE EUROPEAN ASSOCIATION FOR THE STUDY OF THE LIVER

Includes presentations on liver transplantation, cirrhosis, tumors and viral hepatitis

May 7-11, San Juan, Puerto Rico

19th INTERNATIONAL CONFERENCE ON ANTIVIRAL RESEARCH

Includes presentations on antiviral drug and antiviral chemotherapy research

May 15-20, Toronto

ANNUAL MEETING OF THE AMERICAN PSYCHIATRIC ASSOCIATION

Includes presentation from Nymox Pharmaceutical Corp. on AlzheimAlert, a urine-based diagnostic aid, and its successful clinical studies

May 17, Gaithersburg, Md.

PERIPHERAL AND CENTRAL NERVOUS SYSTEM DRUGS ADVISORY COMMITTEE MEETING (FDA)

Includes discussion on Novartis Pharmaceuticals Corp.'s supplemental New Drug Application 20823, SE1-016, Exelon capsules for mild to moderate dementia associated with Parkinson's disease


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