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FDA Law Weekly

Susan Hasty, Publisher

Table of Contents . . . August 12th, 2004

Non-Subscriber - Summaries Only

Related Areas: Other Issues in FDA Law Weekly | Other Publications

Titan, Pharmaceuticals, Inc - Spheramine for Parkinson receives FDA fast track designation

American Pharmaceutical Partners, Inc. - Tobramycin powder launched, marking company's first NDA approval

Atrix Laboratories, Inc. - Tentative approval granted from FDA for Mometasone cream

Barr Pharmaceuticals, Inc. - Response submitted to FDA in support of OTC status for emergency contraceptive

BioMimetic Pharmaceuticals, Inc. - Approvable recommendation issued from FDA panel for GEM 21S

Bioterrorism - Report shows bioterrorism preparedness progress lacking in rural areas

Blood Safety - West Nile prompts rethinking of blood donors

Bone Care International, Inc. - Adair-Greene named to market kidney disease drug

Boston Scientific Corporation - FDA grants approval for trial of Liberte paclitaxel-eluting stent

Bristol-Myers Squibb - REYATAZ received FDA approval to include new data and dosing in package insert

Cell Genesys, Inc. - Phase III trial of GVAX prostate cancer vaccine initiated

Cell Therapeutics, Inc. - Fast track designation issued for pixantrone

Chembio Diagnostics, Inc. - Clinical trials begin for HIV lateral flow rapid tests

Cook, Inc. - First U.S. clinical investigation of Fenestrated AAA Endovascular Graft begins

Corautus Genetics, Inc. - FDA approves phase IIB clinical trial of VEGF-2 via direct injection catheter

AVANT Immunotherapeutics, Inc. - ROTARIX vaccine approved by Mexican authorities for gastroenteritis in infants

Abbott Laboratories - Drug-induced mutants guide the development of new HCV protease inhibitors

Abbott Laboratories - Pharmaceutical firm shares results from programs to fight HIV/AIDS

Advanced BioScience Laboratories - First patients enrolled in HIV vaccine trial

All India Inst. Medical Science - Spironolactone more effective than metformin in comparison study

Almaden Research Center - Scientists make breakthrough in Nanoscale magnetic resonance imaging

American College of Chest Physicians - Pulmonary arterial hypertension guidelines caution calcium channel blocker use

Antisense Therapeutics Limited - Drug developer establishes new research laboratory

Arbios Systems, Inc. - Positive preclinical data reported on blood purification device

Arizona Oncology Services - Brachytherapy saves breast, decreases treatment time

Asthma - Effect of pregnancy and stage of pregnancy on asthma severity investigated

Barcelona Independent University - New genetic mechanism for evolution described

Bioject Medical Technologies, Inc. - Agreement signed to develop disposable-cartridge jet injection system

Biomira, Inc. - Deal signed for the discovery of cancer treatment efficacy markers

Biota Holdings, Ltd. - GSK hepatitis C research collaboration concludes

Boehringer Ingelheim - Mothers, babies in South Africa will continue nevirapine monotherapy for now

Boehringer Ingelheim - Tipranavir safety, pharmacokinetics data reported at AIDS conference

Brain Cancer - Combining brain cancer treatments can give patients more time

Breastfeeding - Obese mothers have weaker biological response to infant suckling

Bristol Myers Squibb - West African community joins network of community-based treatment support programs

Bronx Lebanon Hospital Cntr. - Treatment regresses left ventricular hypertrophy more in women than men

Cancer Diagnosis - Cancer Centers of Florida uses mobile PET system

Capital Univ. of Medical Science, Beijing - ACE inhibitors can treat incidental atherosclerotic renal artery stenosis

Celera Genomics Group - X-ray crystal structure of a human histone deacetylase published

Children's Hospital Eastern Ontario - Malaria prevention and therapy reviewed

Children's Hospital Oakland - Lipids and lipoproteins in patients with type 2 diabetes reviewed

Children's National Medical Center - Dexmedetomidine facilitates opioid and benzodiazepine detoxification

Chinese Academy of Medical Sciences - Acupuncture points are excitable muscle/skin-nerve complexes

Chiron SRL - Vaccine safe and effective against H. pylori infection in dog model

Chong Kun Dang Research Institute - Substituted pyridines and purines possess hypoglycemic activity

Cincinnati Children's Hospital Medical Center - Rotavirus IgA stimulated by doses of quadrivalent rotavirus vaccine

Cleveland Clinic Foundation - Surgical management of erectile dysfunction reviewed

Consejo Superior de Investigaciones Cientificas - Host cell gene expression changes after vaccinia virus infection

Dana-Farber Cancer Inst. - Study suggests broader chemotherapy attack may be more effective

Diet and Nutrition - Research reveals married women diet much more than single women

Duke University Medical Center - MRSA and vancomycin-resistant enterococci associated with adverse outcomes

Eli Lilly & Co. - Bladder-sparing treatment shows promise against cancer

Emory University - Immunological memory in humans reviewed

Endo Pharmaceuticals Holdings, Inc. - Pain-management company reports positive second-quarter results

Entropin, Inc. - Company successfully completes first phase of topical ENT-103 formulation

Epimmune, Inc. - Preliminary EP HIV-1090 trial data presented at international AIDS conference

Fitness & Wellness - Iowa State University research says fat is good with vegetables

Forbes Medi-Tech, Inc. - Company announces FM-VP4 phase II study

Funding - Billionaire Buffett and wife donate $6 million to hospitals for cancer research

Gilead Sciences, Inc. - Studies Viread and Emtriva published in JAMA

Healthcare Access - Another Ohio hospital chain sued over charitable healthcare

Medical Fraud - Feds say phony hospital inspector worked in West Virginia, along East Coast

Medicare - Indiana Medicare patients will have access to computerized medical tests

Norwood Abbey Ltd. - Medical technology company receives patents, names global medical advisor

Peninsula Pharmaceuticals, Inc. - Biopharmaceutical company begins phase III trial of Doripenem

Prescription Drugs - Crestor maker tells FDA safety complaints are false

R2 Technology, Inc. - FDA approval granted for computer-aided detection system for lung nodules

Salmonella - Health officials say study indicates tomatoes likely cause of salmonella outbreak

Sepracor Inc. - U.S. FDA to review aerosol inhaler for asthma, COPD

Transkaryotic Therapies, Inc. - Pharmaceutical company gets FDA fast track designation for Hunter syndrome drug

U.S. Food and Drug Administration - FDA to establish new cancer office and program to speed drug approvals

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