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Medical Letter on the CDC and FDA

Susan Hasty, Publisher

Table of Contents . . . April 19th, 2006

Non-Subscriber - Summaries Only

Related Areas: Other Issues in Medical Letter on the CDC and FDA | Other Publications

Diabetes Diagnostics - Family history of diabetes increased diabetes risk, risk awareness, and risk-reducing behavior

Disease Control - U.S. FDA prohibits use of antiviral drugs in poultry to help keep drugs effective for humans

HIV/AIDS Vaccine Development - HIV serodetection assay differentiates vaccine- from virus-induced antibodies

Obstetrics - Preterm delivery may be affected by gestational weight changes despite prepregnancy weight

Anthrax Pathogenesis - Macrophages play more dominant role than neutrophils in early host defense against anthrax

Avian Influenza - Managed transition would help mitigate risks in pandemic flu outbreak, expert says

Avian Influenza - Quigley initiates development plan to test QR-441(A) against avian influenza in poultry stocks

Avian Influenza - USDA, DOI, and HHS expand H5N1 avian influenza screening in migratory birds

Breast Cancer - Breast cancer risk may be linked to energy intake/balance in postmenopausal women

Breast Cancer - North American Scientific launches breast brachytherapy initiative

Business & Finance - Corautus Genetics reports 2005 financials, updates on temporary suspension of GENASIS trial

Business Update - Carrington Laboratories shares hit 52-week high as avian flu vaccine presented

Business Update - Covalent Group, Inc. signs $1.3 million in new contracts to support New Drug Applications

Business Update - CytoCore's InPath System upgrades Pap test, offers new drug delivery system

Business Update - Efoora announces results from mad cow disease testing and Scrapie disease rapid assays

Clinical Trials - Arbios receives U.S. FDA allowance to increase patient enrollment for Sepet trial

Clinical Trials - Boston Life Sciences ends Altropane POET-1 phase III trial early to evaluate data

Clinical Trials - GenVec expands TNFerade Phase II pancreatic cancer study into Phase II/III trial

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

Clinical Trials - Spherix meets overseas CRO, moves to finalize phase 3 trial of Naturlose for diabetes

Diabetes Research - Researchers reverse diabetes in mouse model; clinical trial to begin

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

Diet & Nutrition - Diet drug may go OTC, prompting concern about broad use of diet pills

Drug Development - Avicena compound receives orphan drug designation for Huntington disease

Drug Development - GammaCan announces positive pre-IND meeting on VitiGam for metastatic malignant melanoma

Drug Development - Hendra and Nipah viruses neutralized by human monoclonal antibodies

Drug Development - U.S. FDA and the Critical Path Institute announce Predictive Safety Testing Consortium

Drug Development - U.S. FDA grants approval to expand label indication for treprostinil sodium injection

Drug Safety - sanofi-aventis reiterates safety of zolpidem tartrate CIV as indicated in U.S. for insomnia

Epidemiology - In Andaman Islands, leptospirosis seroprevalence is highest among agricultural workers

Finance - Pure Bioscience reports revenues of $59,442 for the second quarter

Food Safety - Bacterial and yeast antagonists control food-borne pathogens on fresh-cut apples

Food Safety - FreshFx use at the picker decreases Salmonella incidence in poultry processing

Gastroenterology - OsmoPrep Tablets granted U.S. FDA marketing approval for colonoscopy prep

Gene Research - Triple helix-forming oligonucleotides mediate targeted cross-linking of the human beta-globin gene

Generic Drugs - Perrigo Company announces U.S. FDA approval for terconazole suppositories

Generic Drugs - U.S. FDA grants tentative approval to ANDA for generic equivalent terbinafine HCL cream 1%

HIV/AIDS Drug Development - Fenretinide inhibits HIV infection by promoting viral endocytosis

HIV/AIDS HAART - RT levels in HIV-1 particles affect susceptibility to NNRTIs but not to lamivudine

HIV/AIDS Pathogenesis - Immature/transitional B cell population is overly represented in advanced AIDS

Healthcare Coverage - HHS approves California plan to expand coverage to unborn children

Hepatitis C Therapy - Novelos Therapeutics files IND with U.S. FDA for novel hepatitis C drug

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

Infectious Diseases - AIDS, TB, malaria, and avian influenza spreading unchecked in Burma

Influenza - HHS Secretary Mike Leavitt joins Governor Rendell at Pennsylvania Pandemic Planning Summit

Influenza - HHS buys more antiviral medication for the strategic national stockpile

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

Information Technology - WaveLight DataLink software-generated data confirms quality of laser eye surgery outcomes

Leishmaniasis - Data advance knowledge in leishmaniasis research

Malaria -  Plasmodium falciparum reinfection can be prevented

Market Analysis - Market report on an influenza pandemic compares available vaccines

Market Analysis - Watson Wyatt survey finds companies preparing for avian flu across globe

Medical Devices - BioLok International receives U.S. FDA clearance for bone augmentation product

Mental Health - Treatment data on methylphenidate HCl extended-release tablets released for U.S. FDA meeting

Mergers & Acquisitions - Spectrum Pharmaceuticals agrees to acquire all oncology drug assets of Targent, Inc.

Multiple Sclerosis - FDA extends review period for reintroduction of Tysabri for multiple sclerosis

Myeloid Leukemia - Ceflatonin receives U.S. FDA orphan drug designation for treatment of chronic myeloid leukemia

Obesity Pathogenesis - Research in obesity pathogenesis provides new insights

Oncology - Cancer metastasis in xenograft models is altered by interleukin-1 blockade

Patents - U.S. patent granted for intellectual property around use of microbeads

Personnel - Deirdre Y. Gillespie, MD, named CEO of La Jolla Pharmaceutical Company

Personnel - Dendreon names Christopher Lockett head of government affairs

Pneumococcal Vaccines - New findings in pneumococcal vaccines described

Product Licensing - Genetic testing company Tm Bioscience acquires sepsis biomarkers from Sirius Genomics

Prostate Cancer - Studies advance knowledge in prostate cancer research

Radiation Therapy - Hitachi receives FDA clearance for PROBEAT proton beam therapy system

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

Smallpox Vaccines - New data illuminates research in smallpox vaccines

Stem Cell Research - Hematopoietic stem cells modeled for autologous transplantation

Stem Cell Research - La protein required for development and establishment of embryonic stem cells

Stomach Cancer - U.S. FDA approves use of docetaxel injection in combination for advanced stomach cancer

Virology - Researchers provide details of new studies and findings in the area of virology

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