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Food and Drug Law Weekly

Susan Hasty, Publisher

Table of Contents . . . April 21st, 2006

Non-Subscriber - Summaries Only

Related Areas: Other Issues in Food and Drug Law Weekly | Other Publications

Aastrom Biosciences, Inc. - Aastrom Biosciences gets orphan drug designation for bone marrow cells

Arbios Systems, Inc. - Arbios receives U.S. FDA allowance to increase patient enrollment for Sepet trial

Attention Deficit Hyperactivity Disorder - Data show adults continue to outpace children in ADHD medication use

Avicena Group, Inc. - Avicena compound receives orphan drug designation for Huntington disease

BioLok International, Inc. - BioLok International receives U.S. FDA clearance for bone augmentation product

Biogen Idec - FDA extends review period for reintroduction of Tysabri for multiple sclerosis

Boston Life Sciences, Inc. - Boston Life Sciences ends Altropane POET-1 phase III trial early to evaluate data

ChemGenex Pharmaceuticals Limited - Ceflatonin receives U.S. FDA orphan drug designation for treatment of chronic myeloid leukemia

Children's Hospital of Pittsburgh - Researchers reverse diabetes in mouse model; clinical trial to begin

For Patients, Inc. - For Patients, Inc.'s CathSling has been approved for Medicare reimbursement

GammaCan International Inc. - GammaCan announces positive pre-IND meeting on VitiGam for metastatic malignant melanoma

GenVec, Inc. - GenVec expands TNFerade Phase II pancreatic cancer study into Phase II/III trial

GlaxoSmithKline - GlaxoSmithKline submits Biologics License Application for FDA approval of FluLaval

GlaxoSmithKline - U.S. FDA approves Flovent HFA inhalation aerosol for children ages 4 to 11

Guidant Corporation - Guidant announces enrollment of first patient in landmark carotid artery stenting study

Acadia Pharmaceuticals, Inc. - Acadia Pharmaceuticals reports positive results from phase II trial of ACP-103

Allergy & Immunology - Survey suggests patients want fast, lasting relief of allergy symptoms

Alpha Innotech Corp. - Alpha Innotech reports 23% revenue growth

American Academy of Allergy, Asthma & Immunology - AAAAI offers 10 tips to ease spring allergy symptoms

American Academy of Allergy, Asthma & Immunology - Research shows atopy can lead to adult-onset asthma

American Academy of Orthopaedic Surgeons - Orthopedic researchers discuss role of gene therapy and stem cells at conference

American Academy of Otolaryngology Head & Neck Surgery - First clinical guidelines issued for treatment of swimmer's ear

American Association for Cancer Research - Scientists making advances in cancer receive international awards

Arius Research, Inc. - Arius Research licenses antibody to Genentech

Bachem AG - Bachem and Debio conclude long-term supply agreement for triptorelin pamoate

Baxter Healthcare Corp. - Baxter launches authorized generic azithromycin for injection

Bioject Medical Technologies, Inc. - Bioject reports 30% increase in revenue in FY 2005

Boston University - LDL receptor deficiency or apoE mutations induce hypertriglyceridemia in mice

Bristol Royal Infirmary & General Hospital - Recent findings in prognostics provide new insights

Business Update - Atherotech's VAP test to be used at Lindora Medical Clinics

Case Western Reserve University, Cleveland - Coping among older-adult, long-term cancer survivors analyzed

Catholic University of Korea, Seoul - C-reactive protein release patterns after ASCT correlate with leukemic relapse

Central Drug Research Institute, Lucknow - Data advance knowledge in leishmaniasis research

Centro di Riferimento Regionale, Turin - MxA appears to be a biomarker for IFNP, but there's no evidence of MS role

Chinese University of Hong Kong -  Pneumocystis carinii pneumonia occurs in immunosuppressive disease and therapies

Clariant - Clariant named as partner in Roche Tamiflu supply chain

Cleveland Clinic Foundation - In atrial fibrillation, transesophageal echocardiography-guided cardioversion is effective alternative

Coley Pharmaceutical Group, Inc. - Coley Pharmaceutical Group announces top-line data from clinical study of Actilon for hepatitis C

Columbia University, New York - Sodium hyaluronate shown to provide much needed alternative therapy for chronic shoulder pain

Concepcion University -  Brucella abortus DNA vaccine was evaluated by expression antigen fusion

Cyberkinetics Neurotechnology Systems, Inc. - Cyberkinetics announces 2005 drop in revenue

DSM Nutrition Products - Antiobesity effect of epigallocatechin gallate from green tea deserves more attention

Decision Resources, Inc. - Drugs from three companies will propel obesity drug treatment market to over $1.5 billion

Diet & Nutrition - Bottled water drinkers need information to choose between fluoridated and non-fluoridated brands

Dokuz Eylul University, Izmir - Cardioversion success in atrial fibrillation is predicted by atrial appendage-flow velocity

Duke University, Durham - Cancer treatment regimen combining gefitinib, capecitabine, and radiation produced toxicity

Eli Lilly & Company - Lilly and Biosite sign agreement to collaborate on clinical trial of severe sepsis drug

Emergency Medicine - Advancements in military orthopaedics aid in care of injured service personnel

Emory University, Atlanta - Reports describe recent advances in HIV/AIDS vaccines research

EntreMed, Inc. - EntreMed's preclinical data supports 2ME2's DMARD activity in rheumatoid arthritis

Finland National Public Health Institute - MTB resistance to isoniazid and rifampin simultaneously detected by DNA line probe assay

Gaziantep University - Chronic hepatitis B in children is treatable using immunomodulation therapy

Generex Biotechnology Corporation - Preliminary results reported from Generex Oral-lyn trial in young adults with type 1 diabetes

Genmab A/S - Genmab Reports ACR50 and ACR70 results in HuMax-CD20 study to treat rheumatoid arthritis

Georgia Institute of Technology - New biodegradable polymers show drug delivery potential

Hitachi America, Ltd. - Hitachi receives FDA clearance for PROBEAT proton beam therapy system

MediSpectra, Inc. - U.S. FDA approves new imaging system to help detect cervical pre-cancerous cells

Mount Sinai School of Medicine, New York - Topical vaginal microbicides require vigorous testing for safety and efficacy

Novelos Therapeutics, Inc. - Novelos Therapeutics files IND with U.S. FDA for novel hepatitis C drug

Purdue University, West Lafayette - Purdue project could help pets serve as disease watchdogs

Specialty Pharmaceuticals Division of McNeil PPC, Inc. - Treatment data on methylphenidate HCl extended-release tablets released for U.S. FDA meeting

U.S. Department of Health & Human Services - HHS Secretary Mike Leavitt joins Governor Rendell at Pennsylvania Pandemic Planning Summit

U.S. Food & Drug Administration - HIV serodetection assay differentiates vaccine- from virus-induced antibodies

U.S. National Cancer Institute - Studies advance knowledge in prostate cancer research

United Therapeutics Corporation - U.S. FDA grants approval to expand label indication for treprostinil sodium injection

University of California, Berkeley - UC Berkeley team helps win approval for life-saving post-partum drug for African women

University of Hong Kong - New findings in the area of avian influenza described

University of New South Wales, Sydney - Norovirus genotype variant associated with global gastroenteritis outbreaks

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