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Recent News and Articles on the Keywords: roche laboratories + hhs secretary + hhs  Related to the article below (Last Update: 5/13/2008)

Tough Insurance Climate, Costly Gene Dxs Prompt Rise in ...
Pharmacogenomics Reporter (subscription), NY - Apr 16, 2008
According to an assessment of LabCorp's system by the HHS Secretary's Advisory Committee on Genetics, Health, and Society the company begins the process by ...
Issuing RFI, NIGMS Hopes to Identify Most Pressing Needs in PGx ...
Pharmacogenomics Reporter (subscription), NY - Apr 16, 2008
... including the Agency for Healthcare Research and Quality, the Centers for Disease Control, FDA, as well as the HHS Secretary's Advisory Committee on ...
Source: Google News

PUBLIC HEALTH: A Case Study of Personalized Medicine
SH Katsanis, G Javitt, K Hudson - Science, 2008 - sciencemag.org
... Clinical Laboratory Improvement Amendments of 1988, US Code ... for in Vitro Diagnostic
Use" (Roche Diagnostics, North ... of the Secretary of HHS" [National Institutes ...
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ACS Releases New Breast Cancer Facts & Figures
NP Reduces - CANCER PRACTICE, 2002 - ingentaconnect.com
... US Department of Health and Human Services (HHS) Secretary Tommy G ... www.hhs.gov/news. ...
a combination of capecitabine (Xeloda, Roche Laboratories) and docetaxel ...

[PDF] DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Designation of a … -
SM Peay, C Representative, FT Representative, OI … - Transactions Granted Early Termination, 2006 - drugfreeworkplace.gov
... A laboratory must have its letter of certification from HHS/SAMHSA (formerly:
HHS/NIDA) which attests ... (Formerly: Roche Biomedical Laboratories, Inc ...
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SARS: seeking a real-time solution.
T Wright, RM Poole - Inpharma Weekly, 2003 - inpharma.adisonline.com
... time PCR detection on the Roche LightCycler system ... The company said its reference
laboratory in Cypress, CA ... In April, HHS Secretary Tommy Thompson requested that ...

[CITATION] Abbott Laboratories and Its Price Increase of Norvir
B Harstad, B Gould, B Kozlowski, D Mann, N Shah, V …

Report on the Genetic Alliance Summit -
J Zimmermann - Genetic Testing, 2007 - liebertonline.com
... the details of a recently announced DHHS ef- fort ... and Dan Troy, and James Kelly of
Roche Diagnostics ... testing kits and analytes but not laboratory-developed tests ...
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Influenza antiviral drugs and patent law issues
BT Yeh - CRS Report for Congress - ipmall.fplc.edu
... Human Services (HHS) Secretary Michael Leavitt has explained that the ... in small
quantities in a laboratory environment, although Roche argued that it ...

The Food and Drug Administration
JJ CEREGH1NO - The Medical Treatment of Epilepsy, 1992 - books.google.com
... FDA within the Department of HHS and authorizing the ... clonazepam Tegreto1 Klonopin
Geigy Roche 1978 1981 ... Practice (GMP) and Good Laboratory Practice (GLP ...
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US States Plan How to Handle Pandemic Flu Threat
FDAAS Vaccine - Clinical Infectious Diseases, 2006 - UChicago Press
... A WHO-approved laboratory has another 24 h to confirm ... it had for the first time asked
Roche to be ... The Health and Human Services (HHS) Deputy Secretary, Alex ...

Six Phases of Pandemic Alert?WHO
FDAAS Vaccine - UChicago Press
... A WHO-approved laboratory has another 24 h to confirm ... it had for the first time asked
Roche to be ... The Health and Human Services (HHS) Deputy Secretary, Alex ...

Source: Google Scholar

 

HHS Secretary Mike Leavitt today announced a contract award with Roche Laboratories, Inc. to provide oseltamivir phosphate (Tamiflu®) to all 50 states, the District of Columbia, five U.S. territories and the three Freely Associated States of the Pacific at a federally subsidized price. The contract will run for a period of two years with a total contract award amount of $149,110,000.

“Our ultimate goal is to stockpile sufficient quantities of antiviral drugs to treat 25% of the U.S. population,” Secretary Leavitt said. “Helping the states develop their own medical stockpiles will facilitate quicker distribution of antiviral drugs in the event of a pandemic influenza outbreak.”

Under the HHS contract, 59 jurisdictions will be able to purchase at federally negotiated price from Roche and will receive a 25% federal subsidy for a prescribed number of treatment courses. A complete table of projected antiviral purchases and subsidized allocations for all jurisdictions is posted online at http://www.pandemicflu.gov/state/antivirals.html

The up to 31 million antiviral courses that will be acquired through this contract are in addition to 44 million treatment courses the federal government has begun to purchase without state funding contributions for future distribution to states.

This is latest step in a comprehensive plan to prepare for a pandemic influenza. Since last fall, HHS has joined with state and local officials to conduct pandemic preparedness summits in all but two states, and the remaining two summits are now scheduled. Summits have also been held in Puerto Rico and the Caribbean and Pacific territories, and with Tribal leaders.

More information on pandemic preparedness including the second Preparedness Planning Update dated June 29, 2006 can be found online at www.pandemicflu.gov

NHLBI Offers Updated Guide with Practical Information for Lowering High Blood Pressure through Diet

If you’re one of the 65 million American adults, one in three, with high blood pressure, you have probably heard the advice, “watch your diet, cut back on salt.” But how? Figuring out what to eat and how much to eat is not always simple.

The National Heart, Lung, and Blood Institute (NHLBI) has developed “Your Guide to Lowering Your Blood Pressure with DASH” to provide step-by-step advice on lowering and controlling high blood pressure by following the DASH eating plan. DASH, which stands for Dietary Approaches to Stop Hypertension, follows heart-healthy guidelines to limit salt or sodium, saturated fat, trans fat, and cholesterol, and focuses on increasing intake of fruits, vegetables, and fat-free or low-fat milk products. It is also rich in whole grain products, fish, poultry, and nuts.

“NHLBI studies have shown that the DASH eating plan can significantly lower high blood pressure, even within the first few weeks,” said NHLBI Director Elizabeth G. Nabel, M.D. “They demonstrate that by making healthy choices in diet and physical activity, you can get on track to a healthier life.”

The new guide updates previous publications of the DASH Eating Plan with a new look and is consistent with the 2005 U.S. Dietary Guidelines for Americans. It also contains new information on potassium, weight loss, physical activity, a week’s worth of menus, easy-to-prepare recipes, and a food diary for recording what you eat and the physical activity you do. In addition, the guide provides tips for heart-healthy choices at every meal, even when dining out, and for increasing physical activity.

Sometimes getting started on a heart-healthy eating plan can be the hardest part. The guide provides practical advice and suggestions for beginning with small changes such as:

  • If you eat only one or two servings of vegetables per day, try adding one serving at lunch and another at dinner.
  • Gradually switch to fat-free or low-fat milk and reduce servings of soda or other sweetened beverages.
  • Choose whole grain foods, such as whole wheat bread or whole grain cereals to get added nutrients, such as minerals and fiber.
  • When shopping, read the Nutrition Facts label on foods to find sodium content, and choose items lowest in salt or sodium.
  • Start with a simple 15-minute walk during your favorite time of day and slowly build up.
  • Don’t worry about a slip. Start again, and be sure to celebrate successes.

The DASH guide is available for ordering through the NHLBI Information Center, (301) 301-592-8573 or 240-629-3255 (TTY) or online at http://hp2010.nhlbihin.net/yourguide/

DASH is used as an example of a healthy eating plan by the U.S. Dietary Guidelines for Americans, 2005. DASH is also featured in a consumer book, A Healthier You: Based on the Dietary Guidelines for Americans, published by the U.S. Department of Health and Human Services.

Information is available on the Web at:

Your Guide to Lowering High Blood Pressure With DASH
(http://www.nhlbi.nih.gov/health/public/heart/hbp/dash/index.htm)

Dietary Guidelines for Americans 2005 and A Healthier You
(http://www.healthierus.gov/dietaryguidelines/)

Part of the National Institutes of Health, the National Heart, Lung, and Blood Institute (NHLBI) plans, conducts, and supports research related to the causes, prevention, diagnosis, and treatment of heart, blood vessel, lung, and blood diseases; and sleep disorders. The Institute also administers national health education campaigns on women and heart disease, healthy weight for children, and other topics. NHLBI press releases and other materials are available online at: www.nhlbi.nih.gov.

The National Institutes of Health (NIH) — The Nation's Medical Research Agency — includes 27 Institutes and Centers and is a component of the U. S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical, and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov
 
 
 

The Food and Drug Administration (FDA) today approved Lucentis (ranibizumab injection) for the treatment of patients with neovascular (wet) age-related macular degeneration (AMD). Lucentis is the first treatment which, when dosed monthly, can maintain the vision of more than 90 percent of patients with this type of AMD. Lucentis is a new molecular entity (NME), meaning it contains an active substance that has never before been approved for marketing in any form in the United States. Lucentis will be the first FDA--approved product to provide prescription information in the new format for prescription drug package inserts, to provide professionals and consumers clear and concise prescription information.

 "This approval is of great importance for the 155,000 Americans who are diagnosed each year with AMD, a common cause of severe and irreversible vision loss in older adults," said Dr. Andrew von Eschenbach, Acting Commissioner of Food and Drugs. "At a time when our elderly population is rapidly increasing, this product preserves quality of life for those affected by this disease, helping them to regain the ability to participate in everyday activities such as reading and driving."

 AMD, a retinal disease causing severe and irreversible vision loss, is a major cause of blindness in individuals older than 55 years. Untreated, the majority of eyes affected with wet AMD may become functionally impaired. Wet AMD, which accounts for 10 percent of all AMD, is responsible for 80 percent of the associated vision loss.

The vision loss in wet AMD is caused by the growth of abnormal leaky blood vessels that eventually damage the area of the eye responsible for central vision. Lucentis is designed to block new blood vessel growth and leakiness, which ultimately lead to disease progression and such vision loss.

Lucentis, a biologic product, administered by injection into the eye, was shown to be safe and clinically effective in three multicenter, randomized studies of patients representative of the population usually affected with AMD. In clinical trials, nearly 95 percent of the participants who received a monthly injection maintained their vision at 12 months compared to approximately 60 percent of patients who received the control treatment.

Approximately one-third of patients in these trials had improved vision at 12 months. In a single study carried out for 24 months, these findings have been maintained with continued monthly dosing. The most commonly reported adverse events included conjunctival hemorrhage, eye pain, floaters, increased eye pressure and inflammation of the eye.  Serious adverse events were rare and often related to the injection procedure including endophthalmitis (severe inflammation of the interior of the eye), intraocular inflammation, retinal detachment, retinal tear, increased eye pressure and traumatic cataract.

Lucentis is manufactured by Genentech, Inc. in South San Francisco, California.

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