Medical Letter on the CDC & FDA articles from March 2009

Medical Letter on the CDC & FDA archives from March 2009

Research from Georgetown University in the area of breast implants published.
March 1, 2009... "Over the past 30 years, silicone-gel breast implants and their manufacturers have experienced a tumultuous relationship with the FDA and the public, which has changed the modern climate of industry oversight and the field of plastic surgery,"...

OSI Pharmaceuticals Announces Notification of ANDA Filing for Tarceva.
March 1, 2009... OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) announced receipt of a Paragraph IV Certification Notice Letter advising that Teva Pharmaceuticals USA, Inc. submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration...

Research from University of California broadens understanding of surgery.(Report)
March 1, 2009... According to a study from the United States, "The development of postoperative granulation tissue is one of the main postoperative risks after lumbar spine surgery. This granulation tissue may lead to persistent or new clinical symptoms or...

Reports summarize breast cancer screening research from R.K.F. Hogben and co-authors.
March 1, 2009... "Purpose of review This year, the National Health Service Breast Screening Programme in the UK (NHSBSP) celebrates its 20th anniversary. Since 1988, it has evolved with the help of randomized control studies to become more efficient at picking...

New cholestasis study results from University of Tokyo described.
March 1, 2009... According to a study from Hongo, Japan, "The reduced expression of the bile salt export pump (BSEP/ABCB11) at the canalicular membrane is associated with cholestasis-induced hepatotoxicity due to the accumulation of bile acids in hepatocytes....

New Escherichia coli study findings recently were reported by M.B. Jenkins and co-researchers.
March 1, 2009... According to recent research from the United States, "To better understand the transport and enumeration of dilute densities of Escherichia coli O157:H7 in agricultural watersheds, we developed a culture-based, five tube-multiple dilution most...

Researchers from Fudan University report on findings in legionnaire disease.
March 1, 2009... According to recent research from Shanghai, People's Republic of China, "To determine Legionella pollution prevalence, describe the amount of Legionellae with respect to temperature in Shanghai cooling tower water (CTWs) in various types of...

Study results from C.W. Chang and colleagues in the area of legionnaire disease published.
March 1, 2009... According to recent research from Taipei, Taiwan, "To assess chlorine susceptibility of Legionella pneumophila grown from two amoebic hosts, Acanthamoeba castellanii and Hartmannella vermiformis. After being released from amoebae, Leg....

Photocall: Roman Centurions at Euston Station, 16 February.
March 1, 2009... Customers arriving for the 0710 Euston - Chester service on Monday 16 February may be surprised to have their tickets checked by four Roman Centurions in full authentic regalia. The legionnaires will then travel with customers to Chester,...

Healthcare Online Regulations Discussed in Live Event and Webcast Hosted by Waggener Edstrom Worldwide.
March 1, 2009... Global multiservice public relations agency Waggener Edstrom Worldwide (WE) will present a live panel discussion titled "Healthcare Communications in the Digital World: Mitigating the Risks in a Highly Regulated Environment." The presentation...

Research in the area of angiogenesis reported from Columbus Children's Hospital.
March 8, 2009... According to recent research from the United States, "Approval of the anti-vascular endothelial growth factor (VEGF) antibody bevacizumab by the FDA in 2004 reflected the success of this vascular targeting strategy in extending survival in...

Study data from University of Virginia provide new insights into aortic disease.(Report)
March 8, 2009... "Endovascular repair of thoracic aortic disease is rapidly progressing as an alternative to open surgical therapy. In March of 2005, the Gore TAG thoracic endoprosthesis (W.L," investigators in the United States report (see also Aortic...

IRIS International Reports Record Q4 and Full Year 2008 Revenue and Earnings.(Financial report)
March 8, 2009... IRIS INTERNATIONAL, INC. (NASDAQ: IRIS), announced record fourth quarter 2008 revenue of $26.7 million, an increase of 22% over revenue of $21.9 million in the fourth quarter of 2007, and record full year revenue of $95.5 million for the year...

New life sciences study findings have been reported by researchers at Northwestern University.
March 8, 2009... "WE SURVEYED IRB CHAIRS IN THE United States to ascertain whether their IRBs have clarity regarding their FDA-mandated role in reviewing humanitarian use device (HUD) applications, which are neither research devices nor fully tested...

Studies conducted at E.E. Bartlett et al on life sciences recently published.(Report)
March 8, 2009... According to a study from the United States, "INSTITUTIONAL REVIEW BOARDS form the backbone of the human subject protection system. Yet little is known about the characteristics of these committees." "This study compiles and analyzes the...

Findings from S. Urwyler et al in legionnaire disease reported.
March 8, 2009... According to recent research published in the journal Traffic, "Legionella pneumophila, the causative agent of Legionnaires' disease, replicates in macrophages and amoebae within 'Legionella-containing vacuoles' (LCVs), which communicate with...

Research data from Institute Pasteur update understanding of plague.
March 8, 2009... Fresh data on plague are presented in the report 'The Yersinia pestis caf1M1A1 fimbrial capsule operon promotes transmission by flea bite in a mouse model of bubonic plague.' According to a study from Lille, France, "Plague is a zoonosis...

Bovie Medical Corporation Reports Success with Seer Tissue Resection Device Sales and Marketing.
March 8, 2009... Bovie Medical Corporation (the oCompanyo) (NYSE Alternext US: BVX), a manufacturer and marketer of electrosurgical products, announced that the Company has completed numerous successful surgical procedures with its SEER tissue resection device...

Brent and Sam's Announces Expanded Voluntary Recall of Two Previously Recalled Varieties of Archer Farms Brand Cookies.
March 8, 2009... North Little Rock-based Brent and SamEs announced an expanded voluntary recall of two flavors of Archer Farms cookies, which initially were recalled on January 21. The expanded recall includes additional date codes and is being done as a...

Medifast, Inc. Responds to False Claims.
March 8, 2009... Medifast, Inc. (NYSE: MED), a leading clinically-proven portion controlled weight-loss program announced that it will hold an investor call at the close of the market on Wednesday, February 18, 2009 at 4:15 PM EST. The call will address false...

Natural Grocers by Vitamin Cottage Announces Results of Preliminary PCA Tests in Their Products.
March 8, 2009... Natural Grocers by Vitamin Cottage today shared some preliminary findings regarding the peanut butter made in-store using certified organic peanuts from the Peanut Corporation of America (PCA) of Texas (see also Natural Grocers by Vitamin...

ThermaClear[R] Acne Clearing Device Turns up the Heat in Sephora's "High Voltage" Beauty Products Showcase.
March 8, 2009... Therative, Inc., a pioneer in developing advanced skin care products and solutions for consumers, announces that its ThermaClear[R] Acne Clearing Device is a highlight of leading beauty retailer SephoraEs oHigh Voltageo showcase of hot,...

Wonderware InBatch 9.0 Simplifies Complex Batch Operations Across Existing Systems.
March 8, 2009... Wonderware, a business unit of Invensys, announced the release of InBatch 9.0, an enhanced, flexible and scalable batch management solution (see also Wonderware). InBatch software addresses the needs of the most complex batching processes...

Investigators at Allergan, Inc. have published new data on breast implants.
March 15, 2009... According to recent research published in the journal Annals of Plastic Surgery, "Psychosocial outcomes are believed to be a critical factor in determining the success of cosmetic surgery, but little research has focused on measuring these...

New Report by BioTrends Research Group to Highlight the Launch of ULORIC(R) (febuxostat).
March 15, 2009... BioTrends is pleased to announce the fielding of a new syndicated report, LaunchTrends(TM): Uloric(R). Takeda Pharmaceutical Company Limited announced that they received FDA approval for Uloric(R) (generic name: febuxostat) on February 13,...

Data from S. Tsai and colleagues advance knowledge in life sciences.(Report)
March 15, 2009... "Cryoprotectants are substances characterised by their ability to reduce cryoinjury of biological materials during the course of freezing. Unfortunately cryoprotectants can be toxic for cells," scientists writing in the journal Cryoletters...

Investigators at Pinney Associates, Inc target life sciences.(Report)
March 15, 2009... According to recent research from the United States, "Many smokers express a desire to quit smoking by gradually reducing the number of cigarettes they smoke until they stop completely. This study tested the efficacy of nicotine gum in...

New life sciences findings from Emory University described.
March 15, 2009... "The Bass model has been a standard for analyzing and predicting the market penetration of new products," researchers in the United States report (see also Life Sciences). "We demonstrate the insights to be gained and predictive...

Press Statement Issued by Ranbaxy Laboratories Limited.
March 15, 2009... Ranbaxy has just received a letter and information indicating that all pending and approved ANDAs from Ranbaxy's Paonta Sahib facility have been added to a list maintained under a policy entitled "Application Integrity Policy" or "AIP". Ranbaxy...

TRIA Beauty Announces New and Improved TRIA Laser Hair Removal System.
March 15, 2009... TRIA Beauty announced the launch of a new TRIA Laser Hair Removal System that is faster and at a lower retail price than the original model launched last year. TRIA Laser Hair Removal System is the first and only hand-held laser for at-home...

Findings in environmental health reported from National Institute of Environmental Health Sciences.(Clinical report)
March 22, 2009... "Most diseases are complex in that they are caused by the joint action of multiple factors, both genetic and environmental. Over the past few decades, the mathematical convenience of logistic regression has served to enshrine the Multiplicative...

Data on Huntington disease discussed by researchers at National Institute on Aging.(Report)
March 22, 2009... "The aim of this study was to find an effective treatment for the genetic form of diabetes that is present in some Huntington's disease patients and in Huntington's disease mouse models. Huntington's disease is a neurodegenerative disorder...

New life sciences research reported from L.R. Jones and co-authors.
March 22, 2009... "Photodynamic therapy (PDT) is FDA-approved for use in patients with Barrett's esophagus using porfimer sodium (2 mg per kg) and a recommended light dose of 130 J cm(-1) for high grade dysplasia. Despite uniform drug and light doses, the...

Wyeth Comments on U.S. Supreme Court Ruling in Levine Preemption Case.
March 22, 2009... The U.S. Supreme Court's ruling in Wyeth v. Levine is disappointing, not only for Wyeth, but for patients and public health in general. Patients are best served by a national standard for the labeling of prescription medications -- set by the...

New findings from J.P. Gomes and co-authors describe advances in chlamydia.
March 22, 2009... According to a study from Lisbon, Portugal, "Several European countries identified an ongoing LGV outbreak, particularly among men who have sex with men (MSM). In Portugal, no particular surveillance measures were launched." "Nonetheless,...

Reports outline Escherichia coli study results from Osaka University.
March 22, 2009... According to a study from Suita, Japan, "Enterohemorrhagic Escherichia coli (EHEC) delivers virulence factors into host cells through the type III secretion system (T3SS) to exert the bacterial pathogenicity. EHEC encodes more than 20 type III...

Scientists at Tufts University, Medical Department detail research in legionnaire disease.
March 22, 2009... "The bacterial pathogen Legionella pneumophila replicates in a specialized vacuole within host cells. Establishment of the replication vacuole depends on the Dot/Icm translocation system that delivers a large number of protein substrates into...

Reports outline life sciences study results from A. Evstigneeva et al.
March 22, 2009... New investigation results, 'Amoeba co-culture of soil specimens recovered 33 different bacteria, including four new species and Streptococcus pneumoniae,' are detailed in a study published in Microbiology. According to recent research from...

Adoodle, Inc. Releases New, All Natural, Odor-Blocking NOXO Formulation.
March 22, 2009... Adoodle, Inc. ( ADDE.PK ) is pleased to announce a new and improved, all natural formulation for NOXO which is immediately available for both wholesale and retail purchase. NOXO is a skin cream , applied topically under the nostrils, consisting...

Pliant Wins Multiple 2009 FPA Achievement Awards.
March 22, 2009... Pliant Corporation is the proud winner of two 2009 FPA Achievement Awards: a silver award for Technical Innovation as well as a silver award for Printing Achievement. This is the fifth year in a row that Pliant has received awards from the...

American Society of Anesthesiologists (ASA) - Myths About 'Never Ending Pursuit of Patient Safety and Satisfaction' Debunked.
March 29, 2009... Pulse oximeters became available in 1983, making each patient's oxygen status known on a beat-by-beat basis. Not until 1990, did the American Society of Anesthesiologists (ASA) say that all patients should have this monitor. No articles on this...

Recent findings in life sciences described by researchers from Harvard University, Medical Department.
March 29, 2009... "We developed a screening procedure to identify small-molecule compounds that altered infection by Listeria monocytogenes to gain insights into bacterial/host cellular processes required for intracellular pathogenesis. A small-molecule library...

Mead Johnson Nutrition First Infant Formula Manufacturer to Receive EFSA Favorable Opinion.
March 29, 2009... Mead Johnson Nutrition Company (NYSE: MJN) announced that it is the first infant formula manufacturer to receive scientific endorsement for a health claim on infant formula by the European Food Safety Authority (EFSA). The EFSA Panel on...

Scientists at Hong Kong Polytechnic University publish new data on myeloma.
March 29, 2009... "Multiple myeloma (MM) is considered predominantly a cancer of the elderly with a median patient age of 60-65 years at diagnosis and 88% of patients being over 55 years. The disease has remained incurable with a mean survival period of about 3...

Findings from GlaxoSmithKline provide new insights into pharmacology.
March 29, 2009... According to a study from Greenford, the United Kingdom, "Over the past four years, the annual US FDA-DIA pharmacogenomic workshops have brought together attendees with wide-ranging expertise spanning industry, regulatory authorities and...

Scientists at University of Michigan discuss research in life sciences.
March 29, 2009... A new study, 'Legionella pneumophila couples fatty acid flux to microbial differentiation and virulence,' is now available. According to recent research from the United States, "During its life cycle, Legionella pneumophila alternates between...

enKap Launches FDA Compliance Social Networking Site.
March 29, 2009... enKap (engaged Knowledge application), launched its new web 2.0 technology website this week, and it is already being embraced by quality professionals in FDA-regulated industry (see also enKap). "Over the past 20 years, we have learned...

The Female Health Company to Expand Manufacturing Capacity for FC2 Female Condom By 150%.
March 29, 2009... The Female Health Company (NYSE Alternext: FHC) - announced plans to install six more production lines for its FC2 Female Condom(TM), increasing its annualized FC2 production capacity in Malaysia from 30 million units to approximately 75-80...