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Food & Drug Law Weekly


Susan Hasty, Publisher
Table of Contents . . . September 24th, 2004
Non-Subscriber - Summaries Only
Related Areas: Other Issues in Food & Drug Law Weekly | Other Publications

Arena Solutions, Inc. - Product Lifecycle Management solution available for device industry

AstraZeneca - FDA approves RHINOCORT AQUA for use in pregnant women

Bavarian Nordic - Progress reported in smallpox vaccine development

BioCryst Pharmaceuticals, Inc. - Orphan drug status granted for BCX-1777 in two additional cancer indications

Bioenvision, Inc. - New patient data generated in support of the clofarabine new drug application

Breast Cancer Internl. Res. Group - BCIRG 001 study is the basis for U.S. FDA approval of docetaxel

Bristol-Myers Squibb - Long-term data provides guidance on use of Sustiva in HIV treatment

Cardiovascular Care - Untested catheter used in trials of recalled stent

Cellegy Pharmaceuticals, Inc. - NDA for Cellegesic is accepted for review by U.S. FDA

Cyberonics, Inc. - VNS-focused company raises Q2 earnings guidance

Forest Laboratories, Inc. - Company submits response to U.S. FDA regarding Lexapro for panic disorder

Generic Drugs - Agency defers approval decision for Omnitrope

Genmab, A/S - HuMax-CD4 receives U.S. orphan drug designation

ILEX Oncology Inc. - New patient data to support clofarabine NDA for pediatric leukemia

Internal. Soc. for Pharmacoepidemiology - Risk of heart attack related to COX-2 inhibitors studied

Agile Therapeutics - Contraceptive patch maker closes $4.5M financing

Alba Therapeutics Corporation - Biopharmaceutical firm signs supply agreement with Solvay

Albert Einstein College of Medicine - Prevalence and diversity of M. tuberculosis arabinomannan reported

American Chiropractic Association - Chronic back pain sufferers prefer drug-free pain management, survey shows

Angina - Study shows no benefit from early PCI/CABG in high-risk unstable angina patients

Archet Hospital, Nice - Imatinib mesylate lowers VEGF levels in chronic myeloid leukemia patients

AstraZeneca LP - Ximelagatran does not interact with digoxin

Baxter Healthcare Corp. - Nanoparticle-formulation of drugs can be administered by several routes

Baylor Intl. Pediatric AIDS Initiative - HIV-positive children in resource-limited setting successfully treated

BioFocus plc - Drug discovery alliance to cover multiple targets

Bioenvision - European marketing approval sought for Clofarabine

Biovitrum - Promising oncology project acquired from Axelar

Boston Scientific Corporation - First patient enrolled in trial for paclitaxel-eluting coronary stent system

Bracco - Early findings suggest Isocolan is effective for constipation during pregnancy

Breast Cancer - Counseling boosts immunity, improves health habits

Breast Cancer - Not all women with breast cancer require psychosocial help

Business Update - Boston Scientific stent regains market share, despite August sales

Butler Hospital - ARICEPT may offer hope to those suffering from mild cognitive impairment

CV Therapeutics - Ranolazine study demonstrates important cardiac ion channel effects

ChemNavigator - LION bioscience enters key cheminformatics partnership

Children's Hospital of Philadelphia - Steroids may contribute to increased bone mass in nephritic syndrome patients

Chinese Academy of Science, Beijing - Poly(acrylic acid) inhibits HIV-1 TAR RNA-Tat peptide interaction

Chinese Academy of Sciences - Swelling behavior of alginate-chitosan microcapsules characterized

Columbia University - Gemtuzumab ozogamicin with cytarabine effective in elderly AML patients

Correctional Health - Officials say health contract was renewed in midst of jail deaths

Covalent Group, Inc. - CRO finalizes agreement for $9.7 million of new business

Crucell N.V. - PER.C6-produced HIV vaccine to advance to next phase of clinical trials

Curis, Inc. - Inhibitors of Hedgehog signaling pathway block growth of prostate cancer cells

DarPharma - DAR-0100 to be evaluated in trial for working memory deficits in schizophrenia

Dokuz Eylul University - Report describes upper extremity deep vein thrombosis

Drug Abuse - Alabama doctor starts 'Mothers Against Meth' after losing her own brother

Dynamarketing Group Inc. - New hangover remedy sparks controversy

Encysive Pharmaceuticals - Thelin data presented at the European Society of Cardiology annual congress

Finance - Misonix, Inc., reports record revenues and increased earnings

Flat-D Innovations, Inc. - Company introduces flatulence deodorizing pad

Fourth Military Medical University, Shaanxi - MAGE-n peptide could be immunotherapy target

Fred Hutchinson Cancer Research Center - Researchers uncover a key driver behind progression of prostate cancer

Fujita Health University - Dermatitis-like symptoms seen in HR-1 hairless mice on low magnesium/zinc diet

General Data Company, Inc. - Patient identification wristbands offers error-free bar code and photo ID

Gladstone Inst. of Virology & Immunology - Future of HIV therapeutics is brightening, says expert

Introgen Therapeutics, Inc. - Food, drug law expert joins biopharmaceutical company's board of directors

Kos Pharmaceuticals, Inc. - Positive results announced from inhaled insulin therapy phase IIa trial

Legal Issues - Federal judge reviews Mississippi hospital charity settlement case

Legal Issues - Hospital accused of overcharging uninsured

Lifeline Biotechnologies Inc. - Trinion Meniscus Screw for knee cartilage repair receives U.S. FDA clearance

Medtronic, Inc. - FDA approves left-heart lead for cardiac resynchronization therapy systems

OSI Pharmaceuticals, Inc. - Pharma company and Roche announce filing Tarceva with European Authorities

PerkinElmer Life and Analytical Sciences, Inc. - FDA clears new lab test to help screen newborn infants for congenital disease

Roche - Pharma company submits application to market Xeloda colon cancer treatment

Royal Holloway-University of London - Diversity in pathogenicity can cause outbreaks of meningococcal disease

Schering-Plough Corporation - U.S. FDA approves scent-free prescription nasal inhaled steriod

Seattle Genetics, Inc. - Genetics-focused company gets orphan drug designation for multiple myeloma drug

Siemens Medical Solutions - FDA approves PMA for MAMMOMAT NovationDR

Specialty Laboratories Inc. - Assays to detect Chlamydia and Neisseria gonorrhoeae compared

Swedish Inst. for Infectious Disease Control - Returning travelers could highlight emerging infections worldwide

TriPath Imaging, Inc. - Cancer-focused company submits PMA for HPV test of cervical samples to U.S. FDA

U.S. Food & Drug Administration - Nivalenol induces benign and malignant tumors in mice

Univ. of Texas, Galveston - Scientists find year-round West Nile activity on Gulf Coast

University of Minnesota - Better management of kidney patients may delay need for dialysis

Vaso Active Pharmaceuticals - Pharmaceuticals company, chief executive officer settle with the SEC

West Nile Virus - Donated blood tests positive for West Nile virus

West Nile Virus - Health officials: Don't let your guard down

West Nile Virus - Human case of West Nile virus confirmed in Surry County, North Carolina

West Nile Virus - Michigan's third human case of West Nile confirmed

West Nile Virus - One of Mississippi's first West Nile virus victims fights disease

West Nile Virus - West Nile extends across more of California; death toll hits 11



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