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Opeds: Leavitt on HHS secretary's power; entitlements and fed budget; health threat of Wisc. 'showdown'

If I may, as a former HHS secretary, offer a suggestion to the current secretary, it would be this: Use these expanded discretionary powers to grant states and the private sector more flexibility and more autonomy.

19 Feb 2011

$Grifols to start construction of new plant in Spain for plasma fractionation$

Grifols to start construction of new plant in Spain for plasma fractionation

Grifols, the Spanish group which specializes in the hospital-pharmaceutical sector and is one of the world's leading producers of plasma products, will shortly start construction of a new plant representing an investment of 20 million euros that will employ about 100 people, as soon as it obtains local permits and licenses.

19 Feb 2011

FDA grants CSL Behring marketing approval for Corifact in treatment of congenital FXIII deficiency

CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Corifact™, Factor XIII Concentrate (Human), for the routine prophylactic treatment of congenital factor XIII (FXIII) deficiency. Corifact, already available for use in 12 countries throughout the world under the trade name Fibrogammin®- P, is the first and only FXIII concentrate approved in the U.S.

19 Feb 2011

G20 finance ministers kick off meeting in Paris after groups call for food price issues to be addressed

"G20 ministers gather in Paris Friday to hammer out common criteria for measuring global economic imbalances at a two-day session that host France hopes will lead to an overhaul of world finance," Agence France-Presse reports.

19 Feb 2011

Deep brain stimulation therapy promising against severe OCD

When obsessive-compulsive disorder is of crippling severity and drugs and behavior therapy can't help, there has been for just over a year a thread - or rather a wire - of hope. By inserting a thin electrode deep into the brain, doctors can precisely deliver an electrical current to a cord of the brain's wiring and soften the severity of the symptoms. "Deep brain stimulation" therapy for OCD won Food and Drug Administration approval in 2009 for extreme cases under its humanitarian device exemption.

19 Feb 2011

House to vote on FY11 budget bill, Senate likely to reject it

House Appropriations Chairman Harold Rogers (R-Ky.) said on Thursday that Republicans had reached an agreement with Democrats to reduce the the number of pending amendments to a bill that would fund the government through the end of the current fiscal year, CQ reports (Carter, 2/17). "A final vote on the 2011 budget measure may come as soon as today. It then would go to the Senate, where the Democratic majority is likely to reject the proposal, raising the prospect of a government shutdown," Bloomberg Businessweek reports (Faler, 2/18).

19 Feb 2011

Novavax announces final safety, immunogenicity results from H1N1 VLP vaccine at WHO meeting

Novavax, a clinical-stage biopharmaceutical company, today presented the final safety and immunogenicity results from its 2009 H1N1 virus-like particle pandemic influenza vaccine clinical trial in Mexico at the invitation-only 7th World Health Organization Meeting on Evaluation of Pandemic Influenza Vaccines in Clinical Trials.

19 Feb 2011

Upsher-Smith expands voluntary recall of Jantoven Warfarin Sodium, 3 mg Tablets

Upsher-Smith Laboratories, Inc., of Maple Grove, Minnesota is voluntarily expanding its previously announced recall of Jantoven® Warfarin Sodium, USP, 3 mg Tablets to include additional products that were packaged on the same packaging line between May 17, 2010 and November 17, 2010.

19 Feb 2011

Recent releases in Global Health

Factors Contributing to Health Of Women Worldwide: The Kaiser Family Foundation features a narrated slide tutorial by epidemiologist Laurel Spielberg on the health issues facing women around the world. The tutorial touches on issues such as economic status and biological, social, and cultural factors that affect women's health, as well as access to health services such as family planning (2/17).

19 Feb 2011

Kentucky, Virginia LapBand centers install Crospon's EndoFLIP system

Crospon, an Irish medical device developer based in Galway, has announced that its EndoFLIP system is now being used in two leading LapBand centers in Kentucky and Virginia.

19 Feb 2011

Boys get greater rush and more energy from caffeine than girls

Results of a double-blind, placebo-controlled, dose-response study of the response of youth to caffeine found that, in general, boys get a greater rush and more energy from caffeine than girls.

18 Feb 2011

FDA defends record for approving medical devices

The Food and Drug Administration defended its approval process for medical devices during a congressional hearing Thursday and said industry comparisons with Europe are off the mark.

18 Feb 2011

Impax' NDA for generic version of Adoxa receives final FDA approval

Impax Laboratories, Inc. today announced that the U.S. Food and Drug Administration has granted final approval of the Company's Abbreviated New Drug Application for its generic version of Adoxa.

18 Feb 2011

BioMimetic highlights updates on orthopedic and rehabilitation devices during AAOS meeting

BioMimetic Therapeutics, today announced highlights from its analyst and investor meeting which was held on Thursday, February 17 in San Diego, CA in conjunction with the American Academy of Orthopedic Surgery Annual Meeting.

18 Feb 2011

U.S. FDA posts public health communication about metal-on-metal hip implants use in THA

The U.S. Food and Drug Administration posted a public health communication this week about metal-on-metal hip components to notify the public of the concerns on the use of metal-on-metal hip components used in total hip arthroplasty.

18 Feb 2011

Media examines foreign aid stakeholders' reactions to FY11, FY12 budgets

In the wake of President Barack Obama's fiscal year 2012 budget proposal and the negotiation of the fiscal year 2011 budget bill in the House of Representatives, news outlets looked at stakeholders' responses to the measures and analyzed different pieces of the bills.

18 Feb 2011

Scottsdale Healthcare implants MRI-safe pacemaker

Scottsdale Healthcare Shea Medical Center is the first hospital in the southwestern United States to implant an MRI-safe pacemaker, a major technological breakthrough for patients who need MRI diagnostic scans, which can damage older style pacemakers or cause serious health complications.

18 Feb 2011

Certain uses of terbutaline could lead to maternal heart problems and death, FDA warns

The U.S. Food and Drug Administration is warning that terbutaline administered by injection or through an infusion pump should not be used in pregnant women for prevention or prolonged (beyond 48-72 hours) treatment of preterm labor due to the potential for serious maternal heart problems and death. In addition, oral terbutaline tablets should not be used for prevention or treatment of preterm labor.

18 Feb 2011

Longer looks: KHN's best health policy picks from thought-provoking publications

A law under consideration in South Dakota would expand the definition of "justifiable homicide" to include killings that are intended to prevent harm to a fetus—a move that could make it legal to kill doctors who perform abortions.

18 Feb 2011

Apricus Bio in discussions with FDA for PrevOnco SPA Phase III protocol

Apricus Biosciences, Inc., announced today that it is currently in discussions with the U.S. Food and Drug Administration ("FDA") relating to the PrevOnco™ Special Protocol Assessment ("SPA") Phase III protocol submitted by the Company in December 2010.

18 Feb 2011

Food News and Research

Opeds: Leavitt on HHS secretary's power; entitlements and fed budget; health threat of Wisc. 'showdown'

Grifols to start construction of new plant in Spain for plasma fractionation

FDA grants CSL Behring marketing approval for Corifact in treatment of congenital FXIII deficiency

G20 finance ministers kick off meeting in Paris after groups call for food price issues to be addressed

Deep brain stimulation therapy promising against severe OCD

House to vote on FY11 budget bill, Senate likely to reject it

Novavax announces final safety, immunogenicity results from H1N1 VLP vaccine at WHO meeting

Upsher-Smith expands voluntary recall of Jantoven Warfarin Sodium, 3 mg Tablets

Recent releases in Global Health

Kentucky, Virginia LapBand centers install Crospon's EndoFLIP system

Boys get greater rush and more energy from caffeine than girls

FDA defends record for approving medical devices

Impax' NDA for generic version of Adoxa receives final FDA approval

BioMimetic highlights updates on orthopedic and rehabilitation devices during AAOS meeting

U.S. FDA posts public health communication about metal-on-metal hip implants use in THA

Media examines foreign aid stakeholders' reactions to FY11, FY12 budgets

Scottsdale Healthcare implants MRI-safe pacemaker

Certain uses of terbutaline could lead to maternal heart problems and death, FDA warns

Longer looks: KHN's best health policy picks from thought-provoking publications

Apricus Bio in discussions with FDA for PrevOnco SPA Phase III protocol

The future is bioengineered: Synthetic biology and global sustainability eBook

A New Approach to Preventing Bladder Cancer Recurrence

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

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