FDA Law Weekly

Adams Respiratory Therapeutics - FDA approves Mucinex DM extended-release tablets

American Pharmaceutical Partners - FDA accepts NDA for Abraxane for treatment of metastatic breast cancer

Angiolink Corporation - Device maker submits PMA for vascular closure system

Atrix Laboratories, Inc. - FDA grants approval to market fluticasone cream

Aventis - FDA approves new treatment for prostate cancer

BSD Medical Corp. - FDA approval granted to investigate new cancer treatment applicator

Barr Pharmaceuticals, Inc. - FDA approval granted for Enjuvia (synthetic conjugated estrogens)

Barr Pharmaceuticals, Inc. - FDA issues not approvable letter for over-the-counter emergency contraceptive

Bayer HealthCare - FDA approves first intravenous antibiotic for treatment of pneumonia

Bayer HealthCare, LLC, - Trial investigates MS treatment with Gamunex

Bayer Pharmaceuticals Corporation - Encouraging antibiotic portfolio discussed at European meeting

Bristol-Myers Squibb Co., Gilead Sciences Inc. and - Big pharmaceutical companies pledge to work on AIDS drug

Celeste Contract Packaging - Pharmaceutical packaging company achieves FDA CFR compliance

Cell Genesys, Inc. - Special protocol assessment granted from FDA for trial of GVAX vaccine

Centers for Disease Control & Prevention - Analyses of stool samples should include testing for E. coli O157:H7

Access Pharmaceuticals, Inc. - Second oral drug delivery research deal signed

Aga Khan University - Profiling of leprosy and tuberculosis patients aids vaccine development

Aging - Cancer checks at 80: When is it too old to test?

Ajou University Hospital - vanA cluster rearrangements reduce drug resistance in enterococci

Algeta - Company broadens technology base with radioactive liposomes

Allergy Research Group, Inc. - Nutraceutical research company reports increased first quarter sales

American Fdn. for AIDS Research - HCV therapy with IFN/RBV relatively safe in patients coinfected with HIV and HCV

Anadys Pharmaceuticals, Inc. - Phase I/IIa trial of ANA380 in hepatitis patients completed

Antares Pharma, Inc. - Drug delivery company completes strategic reorganization

Applied Biosystems - Integrated system launched to improve gene expression analyses for whole blood

Axon Instruments, Inc. - GenePix Autoloader microarray scanner launched

BD Biosciences - BD FACSCanto flow cytometry system launched

Barrier Therapeutics, Inc. - Dermatology company reports quarterly loss of $22.62 per share

Bayer HealthCare Biological Products - Clinical trial to investigate treatment for CIDP

Benign Prostatic Hyperplasia - Sexual dysfunction in BPH patients higher than surveyed physicians estimate

BioE, Inc. - New population of multilineage stem cells in umbilical cord blood isolated

BioSurface Engineering Technologies, Inc. - Studies: HepaSil shows significant improvement in ePTFE graft patency

BrainLAB - Fiftieth Novalis shaped beam surgery system sold

Caliber Associates - Residential drug abuse for pregnant women improves birth outcomes

Cancer - Tumor-specific promoters for cancer therapies available for licensing