FDA Law Weekly

Able Laboratories, Inc. - FDA grants approval for Dextroamphetamine Sulfate

American Medical Association - Bioterrorism preparedness dependent on action of health care systems

Ankara Numune Education/Research Hosp. - Ribavarin therapy effective against Crimean-Congo hemorrhagic fever

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

Arrowhead Research Corporation - Researchers announce nanotube breakthrough

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

Bioterrorism - Corvallis business will be studying bioterrorism threat

Bioterrorism - Nebraska gets $3.6 million for bioterrorism, $1.1 million for health centers

Bioterrorism - Texas to receive almost $64 million for bioterrorism defense

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

California Veterinary Medical Association - Chance that dogs or cats will get West Nile virus is 'very unlikely,' vets say

AVI BioPharma, Inc. - Dengue virus collaboration signed with CDC

Advanced Chemistry Development, Inc. - Drug metabolite studies advanced with introduction of MetaboLIMS

Amarin Corporation plc - Results of gene variant data analysis released from Miraxion phase III trial

American Society of Therapeutic Radiology and Onco - Grants, Internet helping to improve radiation oncology workforce shortage

Amgen - Gastrointestinal dendritic cells play role in immunity and tolerance

Annamalai University - Sweet broomweed extract increases level of antioxidants in diabetes

Antares Pharma, Inc. - Pharmaceutical firm appoints Paul K. Wotton to its board of directors

Aphton Corporation - Regulatory application submitted in Canada for Insegia

Aquagen International, Inc. - Agreement signed to develop acne treatment

Australian Animal Health Laboratory - Fowlpox viruses carrying multiple vaccine antigens constructed

Bayer Healthcare Wuppertal - Inhibition of PDEs can disturb vision, elevate heart rate and vasodilation

Bayer Pharmaceuticals Corp. - Apax Partners forms Aerovance through spin out

BioGaia - Study shows chewing gum with Lactobacillus Reuteri Prodentis reduces gingivitis

BioMarin Pharmaceutical, Inc. - Positive data reported from phase Ib trial of Vibrilase for serious burns

CEA/Saclay, Gif-sur-Yvette - H₂ O₂ does not induce antioxidant defenses in mammals

CMS, Inc. - CMS awarded Premier contract

Cancer Prevention - Wyoming to begin developing cancer control plan

Cardiovascular Care - Untested catheter used in trials of recalled stent

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

Chiba Institute of Technology - Novel target site for gene therapy may control/manage HIV-1 infection

Children's Healthcare Atlanta - Bosentan therapy may benefit patients with the Eisenmenger syndrome

Chinese University of Hong Kong - The polysaccharopeptide PSP halts tumor growth through angiogenic inhibition

Cincinnati Burns Hospital - Endothelial cell enhancements will improve their use in skin substitutes

Ctr. for HIV & Hepatogastroenterology, Dusseldorf - Peginterferon and ribavirin safe/effective in HCV-infected methadone patients