Food and Drug Law Weekly
Susan Hasty, Publisher
Table of Contents . . . April 16th, 2004
Non-Subscriber - Summaries OnlyRelated Areas: Other Issues in Food and Drug Law Weekly | Other Publications
Allos Therapeutics, Inc. - NDA for radiation therapy sensitizer to be reviewed by FDA panel
Closure Medical Corporation - FDA approves commencement of vascular sealant study
Coapt Systems, Inc. - Endotine Midface ST 4.5 launched for surgical midface suspension
Cygnus, Inc. - GlucoWatch G2 Biographer receives FDA approval to expand labeling
Dey, L.P. - Patent granted for pediatric asthma medication
Environment & Health - Children, some women should limit fish intake, U.S. government says
Exelixis, Inc. - Orphan drug designation granted for anticancer agent XL119
Generic Drugs - FDA approves generic versions of potent painkiller for sale
Gilead Sciences, Inc. - Applications submitted for fixed-dose coformulation of Viread and Emtriva
IR BioSciences Holdings, Inc. - ImmuneRegen gets guidance from FDA and Division of Counter Terrorism officials
Lincoln Technologies Inc. - Database provides international perspective on drug safety profiles
Medtronic, Inc. - FDA clears completely automatic pacemaker
NOP World Health - Physicians watch for increased suicide risk in children on antidepressants
Obstetrics - FDA warns against nonmedical sonograms
Oragenics, Inc. - Committee votes in favor of human trial for dental caries prevention therapy
ActivBiotics, Inc. - Antibiotics maker names new president, CEO
American Academy of Allergy, Asthma & Immunology - New research on the treatment of anaphylaxis presented 2004 AAAAI meeting
Aphios Corporation - Material transfer agreement signed with National Cancer Institute
Arena Pharmaceuticals, Inc. - Pharmaceuticals company hires new chief medical officer
Autoimmune Disease - Researchers say chemo drug may help people with autoimmune diseases
Barrier Therapeutics, Inc. - Joan Chypyha named general manager, Canada at dermatology firm
Bispebjerg University Hospital - A common topical dental treatment also accelerates skin wound healing
Bone Care International, Inc. - Veitinger appointed to board of directors at hormone therapies company
CHADD - Experts assail under-treatment of disorder in African American youth
Cambridge Heart, Inc. - Results of SCD-HeFT sub-study most likely available in 2004
Centers for Medicare & Medicaid Services - Giving antibiotics within 4 hours of arrival at a hospital improves outcomes
Children's Hospital of Philadelphia - Children's hospital studies treatment options for type II diabetes
Contraception - Legislation would require New Jersey insurers to pay for birth control
Cutting Edge Information - Early leader program implementation beneficial to product launch
Dana-Farber Cancer Institute - Genes predict response of adult patients to chemotherapy
Depomed, Inc. - Positive phase III clinical trial results for Ciprofloxacin reported
DevCo Pharmaceuticals, Ltd. - Safety study of Lexipafant completed, phase III commences
Diet & Nutrition - Program boosts rate of breastfeeding by mothers of very low-birth-weight babies
Disease Outbreak - Dengue fever death toll exceeds 500 in Indonesia
Eisai & Co. Ltd - Platelet integrin alpha2 marks the efficacy of angiogenesis inhibitor E7820
Employee Assistance Program - Coaching program enhances EAP, behavioral offerings
EntreMed, Inc. - New Panzem formulation in phase I trial
Enzo Biochem, Inc. - Interim results reported in phase II trial of Alequel
Geron Corp. - Merix Bioscience announces cancer vaccines agreement
Giannina Gaslini Children's Hospital - Caspofungin effective for pediatric cancer patients, bone marrow recipients
HEALTHPOINT, Ltd. - TRISEPTIN surgical scrub selected for military medical treatment facilities
HIV/AIDS - African delegates meet to plan joint response to AIDS pandemic
Inst. St. Catherine, Avignon - Radiotherapy and chemotherapy are the standard of care in locally advanced NSCLC
Interferon Sciences - Hemispherx completes acquisition for worldwide rights to Alferon N
Jefferson Medical College - Study: Needle-free transdermal system as effective as IV pain pump for pain
Johns Hopkins University - Bone mineral loss frequent in female patients during HAART
Kimmel Cancer Institute - Alternative to embryonic stem cell research offered
Kyoto Pharmaceutical University - Cytokine gene therapy staunches murine melanoma
Legal Issues - South Carolina woman arrested in hospital fraud
Lynx Therapeutics, Inc. - Company announces job cuts
Massachusetts Institute of Technology - Scientists want to delay the onset of fatal brain disease
McMaster University, Hamilton - Eosinophil progenitors can migrate to airways
Memorial Sloan-Kettering Cancer Center - HDT+ASCT not effective for patients with relapsed, refractory HD
Mount Sinai School of Medicine, New York - Nonunion still common after spinal fusion treatment
NeoPharm, Inc. - Cancer-drug maker reports increased net loss for fourth quarter, year
Neurocrine Biosciences, Inc. - Hart-Scott-Rodino requirements met for acquisition of indiplon royalty stream
Neurogen Corp. - Drug-development company announces $100 million private placement
Nice University Hospital - Lipid profiles induced by different antiretroviral drugs characterized
Northwestern Memorial Hospital - Study highlights misunderstanding surrounding risks, benefits of tamoxifen
Oregon Health and Science University - Calcium supplementation sustains cortical bone density in young female runners
Oregon State University - Hyaluronic acid enhances the work of cytokine-loaded hydrogel implants
Organon - Public-private endeavor seeks innovative therapies to promote bone regeneration
Pfizer, Inc. - FDA approves new chewable formulation of Zyrtec
Ranbaxy Pharmaceuticals Inc. - Pharmaceutical company to market quinapril hydrochloride tablets
RegeneRx Biopharmaceuticals, Inc. - First TB4 wound healing technology patent issued by Australia
Synovis Life Technologies, Inc. - FDA issues marketing clearance for Navi-Glide Steerable Stylet
U.S. Food and Drug Administration - Thiol/disulfide exchange needed for R4 HIV T-cell fusion during viral entry
West Nile Virus - Louisiana Health Department begins annual test of dead birds for West Nile virus
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