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Food and Drug Law Weekly

Susan Hasty, Publisher

Table of Contents . . . April 9th, 2004

Non-Subscriber - Summaries Only

Related Areas: Other Issues in Food and Drug Law Weekly | Other Publications

American Pharmaceutical Partners - NDA filed with FDA for nanoparticle-based Abraxane

AmerisourceBergen Corporation - Company helps hospitals, manufacturers respond to new FDA rules

Amgen, Inc. - FDA approves Sensipar for the treatment of secondary hyperparathyroidism

Amicus Therapeutics, Inc. - U.S. orphan drug designation granted for AT1001

AstraZeneca - Research explains why anticancer treatment effective for some, not others

BioSante Pharmaceuticals - Nanotechnology drug developer reports key achievement

Bovine Spongiform Encephalopathy - U.S. expands mad cow testing to cover 221,000 animals

Cardiome Pharma Corp. - FDA accepts NDA for oxypurinol

Cima Labs Inc. - Orally disintegrating drug receives FDA approval for schizophrenia

Ciphergen Biosystems, Inc. - ProteinChip system receives medical device certification in China

Daiichi Pharmaceutical Corp. - FDA approves once-daily Floxin Otic (ofloxacin otic solution)

Delcath Systems, Inc. - First patient accepted in phase III liver cancer study

Diagnostic Products Corp. - Diagnostics company cooperating with FDA on Application Integrity Policy

Draximage, Inc. - Skeletal imaging agent approved by FDA

EP MedSystems, Inc. - FDA gives market clearance for cardiac stimulation system

AEterna Laboratories, Inc. - Company expands pipeline to include obesity, oncology therapies

Acute Coronary Syndrome - Women with acute coronary syndrome receive less treatment than men, data shows

Allegheny General Hospital - Cardiac MRI a better predictor of heart attack, death for women

American College of Cardiology - Analysis of NHANES data demonstrates high prevalence of CRP

Aspen Education Group - Therapeutic boarding schools opened for overweight, obese youths

Aspreva Pharmaceuticals Corp. - Autoimmune disease drug maker completes raises $57 million

AstraZeneca - Preoperative treatment with anastrozole reduces need for extensive surgery

Bayer Pharmaceuticals Corp. - Majority of patients taking Levitra report satisfaction

Bayer Pharmaceuticals Corp. - Survey reveals widespread misconceptions about UTI

Beth Israel Deaconess Medical Center - Brain enzyme thought to regulate appetite

Breast Cancer - Older people lose out all around in breast cancer treatment and care

Breast Cancer - Rates of conservation surgery vary widely among countries

Bristol Myers Squibb Co. - Orally active fusion inhibitor of respiratory syncytial virus developed

California Pacific Medical Center - Impact of HCV coinfection on risk of HAART-induced liver damage reviewed

Celltech Americas - Study demonstrates Metadate CD has greater effect than Concerta

Chimerix, Inc. - NIH grant to fund drug development for multidrug-resistant HIV

ChromaVision Medical Systems - Alliance to focus on cancer drug study

Chronogen, Inc. - New management appointments named at drug discovery firm

Cincinnati Children's Hospital - LSBC enters research phase for development of atherosclerosis therapeutic

Cold Spring Harbor Laboratory - Adding drug to standard chemo improves treatment

Complementary & Alternative Medicine - More breast cancer patients seeking little-understood CAM therapies

Complementary & Alternative Medicine - Utah company guarantees nutritional supplements free of banned substances

Compound Therapeutics, Inc. - Protein-based drug developer acquires assets of Phylos

Connetics Corporation - Dermatology company completes Soriatane acquisition

Dental Health - Juneau dentists want fluoride back in water

EUROPA Steering Committee - Perindopril reduces cardiovascular death and heart attack risk in diabetes study

Faculty of Pharmacy, Barcelona - Hepatitis A peptide covalently linked to liposomes

Federal University of Rio Grande do Sul - Novel E. coli system facilitates mycobacterial protein production

GP Surgical - FDA approves TiMESH for hernia repair

German Cancer Research Center - Research leads to hope of a new treatment approach for paralysis

HIV/AIDS - U.N. plan to treat HIV/AIDS sufferers endangered by lack of money

Hannover Medical School - Beta-blocker treatment feasible for many asthma, COPD patients

Healthcare Costs - Louisiana still in limbo over use of healthcare dollars

Hollis-Eden Pharmaceuticals, Inc. - Data presented on molecular mechanism of action for HE2000

Hythiam, Inc. - Michel A. Sucher, MD, named VP clinical affairs of addiction-treatment company

INSERM EMI-U 00.18, Angiers - Food restriction affects energy metabolism in rat liver mitochondria

INSERM, Paris - IFN-alpha with ribavirin can suppress virus-specific immunity

IVAX Corp. - Company receives approval for Paxene in Europe

Influenza - Global flu outbreak could be curbed by worldside stockpile of antiviral drugs

Johns Hopkins University - Self-reported hepatitis B vaccination status unreliable among drug users

Praecis Pharmaceuticals Incorporated - Phase I clinical trial of PPI-2458 in non-Hodgkin lymphoma on hold

Taro Pharmaceutical Industries Ltd. - Phenytoin Oral Suspension receives FDA approval for treatment of epilepsy

U.S. Centers for Disease Control & Prevention - SARS preparedness checklist developed for state and local health officials

U.S. Food and Drug Administration - FDA to determine what low-carb means

University at Buffalo - Chronic sinusitis is an immune disorder; antifungal is effective treatment

University of Michigan - Medical privacy law makes health research harder, more expensive

Vasomedical, Inc. - EECP therapy systems receive FDA 510K clearance for revised labeling

Vion Pharmaceuticals, Inc. - Cloretazine receives Fast Track designation from FDA

eResearchTechnology, Inc. - $1.7M award for cardiac safety monitoring and services announced

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