Medical Letter on the CDC & FDA articles from June 2009

Medical Letter on the CDC & FDA archives from June 2009

Camphor-containing products may cause seizures in children.
June 7, 2009... May 6, 2009 -- (BRONX, NY) -- Inappropriate use of camphor-containing products may be a common and underappreciated cause of seizures in young children, according to a new study by researchers at Albert Einstein College of Medicine of Yeshiva...

New amyotrophic lateral sclerosis findings from Johns Hopkins University, Medical Department published.
June 7, 2009... According to a study from the United States, "In a recent issue of Experimental Neurology, Boston-Hewes and colleagues used an assay of glutamate transport to screen 1040 FDA approved drugs in an attempt to identify compounds that would...

New findings reported from Auburn University describe advances in diabetes.
June 7, 2009... According to recent research from the United States, "To evaluate the pharmacodynamic properties, efficacy, safety, and clinical application of insulin glulisine, a rapid-acting insulin analog, in the treatment of diabetes mellitus in...

Study results from J. Leyden and colleagues in the area of life sciences published.
June 7, 2009... According to a study from the United States, "Newer agents and formulations seek to improve the tolerability of topical retinoid therapy. Recently, a gel containing crystalline clindamycin 1.2% and tretinoin 0.025% (CLIN/RA) was approved by the...

New Clinical Data Shows Significant Improvement in the Appearance of Fat Using SlimLipo(TM) Laser.(Clinical report)
June 7, 2009... Palomar Medical Technologies, Inc. (NASDAQ:PMTI), a leading researcher and developer of light-based systems for cosmetic treatments, announced the success of a clinical study showing the benefits of the SlimLipo body sculpting laser for...

Aesthera Announces ANVISA Clearance to Market Photopneumatic Platforms in Brazil.
June 7, 2009... Aesthera announced the receipt of ANVISA clearance to market their proprietary Isolaz Pro photopneumatic(TM) based platforms in Brazil. ANVISA (Agencia Nacional de Vigilancia Sanitaria) is a Brazilian national health surveillance and regulatory...

'Fight the Bite' Poster Contest Honors 28 Students in 17 States.
June 7, 2009... This year 28 students in 17 states have won awards in the "Fight the Bite" poster contest, sponsored by the Centers for Disease Control and Prevention and the DEET Education Program. Started in 2007, the contest invites fifth- and sixth-grade...

Pallet Buyers Need to be Aware of 'Voodoo' Environmental Claims, Says PALNET USA.
June 7, 2009... The pallet industry has begun to promote green and with that, environmental claims are sprouting up everywhere. A 2008 study conducted by Price Waterhouse found that consumers only believe 16% of environmental claims. There's a good reason why....

ValGenesis, Inc. Announces Worldwide Release of Breakthrough Validation Automation Engine in ValGenesis 2.0.
June 7, 2009... ValGenesis, Inc., a leading provider of Validation Lifecycle Management software solutions, announced the worldwide availability of its Validation Automation Engine (VAE) within the latest version of ValGenesis 2.0. This breakthrough software...

Researchers at Cleveland Clinic target bone research.
June 14, 2009... "CONTEXT: Allograft bone is commonly used in various spinal surgeries. The large amount of recalled allograft tissue, particularly in recent years, has increased concerns regarding the safety of allograft bone for spinal surgery," researchers...

Study findings on discectomy are outlined in reports from D. Murrey and colleagues.
June 14, 2009... According to a study from the United States, "CONTEXT: Cervical total disc replacement (TDR) is intended to address radicular pain and preserve functional motion between two vertebral bodies in patients with symptomatic cervical disc disease...

New hypertension study findings recently were reported by G.J. Peitz and co-researchers.
June 14, 2009... "Aliskiren gained FDA approval for the treatment of hypertension in 2007. It is the first approved pharmaceutical to manage hypertension by direct renin inhibition," scientists writing in the Southern Medical Journal report (see also...

New pharmaceuticals study findings have been published by scientists at University of Frankfurt.(Report)
June 14, 2009... According to recent research from Frankfurt, Germany, "Objectives The dissolution characteristics of immediate-release doxycycline hyclate products with certified in-vivo bioequivalence to the innovator product were tested with I view to...

Report summarizes pharmacokinetics study findings from Cairo University.(Report)
June 14, 2009... According to recent research from Cairo, Egypt, "Olanzapine is a psychotropic agent that belongs to the thienobenzodiazepine class. The aim of this study was to assess the bioequivalence of 2 commercial 10-mg tablet formulations of olanzapine...

Study data from Queen's University provide new insights into Escherichia coli.
June 14, 2009... According to a study from Kingston, Canada, "For many pathogenic microorganisms, iron acquisition from host heme sources stimulates growth, multiplication, ultimately enabling successful survival and colonization. In gram-negative Escherichia...

NutriCompliance Certifies Advanced Red Wine Supplement Revatrol.
June 14, 2009... There are a number of Resveratrol supplements on the market today that claim to be the best, but only one has been certified by NutriCompliance, a regulatory compliance firm. Revatrol, the only advanced red wine extract with 100MG of...

New Crohn disease study results from University of Milan described.(Report)
June 21, 2009... According to a study from Milan, Italy, "Assessing perianal disease activity is important for the treatment and prognosis of Crohn's disease (CD) patients, but the diagnostic accuracy of the activity indices has not yet been established. The...

Gilead Sciences' Marketing Authorisation Application for Regadenoson Validated by European Medicines Agency.
June 21, 2009... Gilead Sciences, Inc. (Nasdaq: GILD) announced that the company's Marketing Authorisation Application (MAA) for regadenoson, an investigational pharmacologic stress agent for radionuclide myocardial perfusion imaging (MPI), was validated by the...

New findings reported from Massachusetts General Hospital describe advances in HIV/AIDS.
June 21, 2009... "Expectations regarding receipt of medications and medical care after clinical trials conclude may inform decisions about trial participation. We describe the frequency with which these posttrial services are described in the protocols and...

Research from G. Maluenda and co-authors in the area of life sciences published.
June 21, 2009... "Drug-eluting stents (DESs) have largely demonstrated their superiority to bare-metal stents (BMSs) with respect to in-stent restenosis. Since the US Food and Drug Administration (FDA) approved the first DES in 2003, there has been a...

Lilly Resubmits Cymbalta(R) Supplemental New Drug Application for Chronic Pain to U.S. Food and Drug Administration.
June 21, 2009... As projected, Eli Lilly and Company (NYSE:LLY) has resubmitted its supplemental New Drug Application (sNDA) for Cymbalta(R) (duloxetine HCl) for the management of chronic pain to the U.S. Food and Drug Administration (FDA). Lilly's resubmission...

New findings from A.V. Semenov and co-authors describe advances in Escherichia coli.
June 21, 2009... According to recent research from Netherlands, "The effect of cattle manure and slurry application on percolation and survival of Escherichia coli O157:H7 and Salmonella enterica serovar Typhimurium was investigated for different soil depths...

Study results from M. Steele and colleagues update understanding of Escherichia coli.(Report)
June 21, 2009... "Populations of the food- and waterborne pathogen Escherichia coli O157:H7 are comprised of two major lineages. Recent studies have shown that specific genotypes within these lineages differ substantially in the frequencies with which they are...

Reports summarize plague research from J.V. Rogers and co-authors.(Report)
June 21, 2009... According to recent research from the United States, "Many aspects of biodefense research require quantitative growth assessments of the test agent." "This study evaluated the BioNanoPore (BNP (TM)) technology to quantitate Bacillus...

Findings from Rutgers University advance knowledge in west nile virus.
June 21, 2009... According to recent research from the United States, "We characterized the first microsatellite loci in the white-dotted mosquito, Culex restuans, a critical early spring West Nile virus vector. An enrichment protocol yielded 960 positive...

Monterey Mushrooms Launches Vitamin D Enriched Sun Grill-A-Bella and White Mushrooms.
June 21, 2009... Through a truly collaborative research effort with the United States Department of Agriculture (USDA), Monterey Mushrooms, Inc. has been successful in replicating what happens in nature when mushrooms are exposed to light (see also Monterey...

Supply Chain Investment Key to Stevia's Competitiveness.
June 21, 2009... The rate of Reb A market penetration and commercial progress demonstrated at Stevia World in Shanghai has generated excitement in the food and beverage industry. Given the high degree of interest currently in the market about stevia, especially...

Meta-Analysis of Clinical Data Showed No Increased Risk of Cardiovascular Events Associated With Exenatide Use: Data Presented at ADA 2009.
June 28, 2009... Amylin Pharmaceuticals, Inc. (NASDAQ:AMLN) and Eli Lilly and Company (NYSE:LLY) announced results from a meta-analysis of cardiovascular (CV) events that showed no increased risk of CV events associated with BYETTA(R) (exenatide) injection use...

New heart disease research from National University described.
June 28, 2009... "Since the Food and Drug Administration (FDA) approved the use of buprenorphine hydrochloride (Subutex) for the treatment of opiate dependence in 2002, there has been a global trend of its IV abuse which led to life-threatening medical...

Study Shows Pentacel[R] Combination Vaccine Provides Safety and Antibody Responses Comparable to Individually Administered US-licensed Vaccines.(Report)
June 28, 2009... Sanofi Pasteur, the vaccines division of sanofi-aventis Group (EURONEXT : SAN and NYSE : SNY), announced the results of a study published in a recent issue of the journal Pediatrics found that Pentacel® (Diphtheria and Tetanus Toxoids and...

Findings from Food & Drug Administration provide new insights into life sciences.
June 28, 2009... "The practicing dermatologist uses many medical devices during his or her day-to-day practice," scientists in the United States report (see also Life Sciences). "The authors present a broad overview of how such medical devices are reviewed...

Reports by P.M. Hyman and co-researchers describe recent advances in life sciences.
June 28, 2009... "Dermatologists have at their disposal a wide range of products to recommend or prescribe to their patients, all of which are regulated in some way by the Food and Drug Administration (FDA). However, the degree to which FDA has confirmed the...

New legionnaire disease research from T. Sahr and co-researchers described.
June 28, 2009... "To transit from intra- to extracellular environments, Legionella pneumophila differentiates from a replicative/non-virulent to a transmissive/ virulent form using the two-component system LetA/LetS and the global repressor protein CsrA. While...

Reports outline legionnaire disease study findings from Boston University, Medical Department.(Report)
June 28, 2009... According to recent research from the United States, "During infection, Legionella pneumophila creates a replication vacuole within eukaryotic cells and this requires a Type IVb secretion system (T4bSS). IcmQ plays a critical role in the...

New life sciences study results from M. Rasis et al described.
June 28, 2009... Current study results from the report, 'The LetA-RsmYZ-CsrA regulatory cascade, together with RpoS and PmrA, post-transcriptionally regulates stationary phase activation of Legionella pneumophila Icm/Dot effectors,' have been published....

Research findings from Purdue University, Department of Biological Sciences update understanding of life sciences.
June 28, 2009... Researchers detail in 'Targeting eEF1A by a Legionella pneumophila effector leads to inhibition of protein synthesis and induction of host stress response,' new data in life sciences. "The Legionella pneumophila Dot/Icm type IV secretion system...

CareFusion Announces Board of Directors, Progress on Alaris Consent Decree.
June 28, 2009... CareFusion Corporation, the company that will become public from the planned spinoff of Cardinal Health's clinical and medical products businesses, today filed a second amendment to its Form 10 registration statement with the Securities and...

Environmental Tectonics Corporation's Sterilization Systems Group Announces $3.5 Million in New Contracts.
June 28, 2009... Environmental Tectonics Corporation's (BULLETIN BOARD: ETCC) ("ETC" or the "Company") Sterilization Systems Group (SSG) announced the award of four new projects from new and repeat customers (see also Environmental Tectonics Corporation). ...

Office of Regulatory Affairs Recipients of FDA Honor Award New Hope Natural Media Standards Department.
June 28, 2009... FDA will honor a business-media company with the agency's Civilian Honor Award, presented on behalf of the Acting Associate Commissioner for Regulatory Affairs, Michael Chappell. On June 26, New Hope Natural Media's Standards Department (NHNM)...

MetricStream and SigmaQuest Partner to Deliver Comprehensive Product Quality Management and Compliance Solutions.
June 28, 2009... MetricStream, the market leader in Global Governance, Risk, Compliance (GRC) and Quality Management solutions, and SigmaQuest, the leader of On-Demand, scalable solutions for product quality management, are partnering on the delivery of...

SofTech Announces the ProductCenter PLM Discovery Program.
June 28, 2009... SofTech, Inc., a proven provider of Product Lifecycle Management (PLM) solutions, announces its ProductCenter™ PLM Discovery Program as a means for companies to achieve the benefits of a PLM solution without the customary uncertainty of...