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POZEN reports net loss of $6.9M for year ended December 31, 2009

POZEN Inc., today announced results for the fourth quarter and year ended December 31, 2009.

3 Mar 2010

Spectral Diagnostics receives FDA IDE approval for Toraymyxin

BioMS Medical Corp. today reported that Spectral Diagnostics has received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) for Toraymyxin(TM). Spectral Diagnostics and BioMS have entered into a services agreement whereby BioMS will assist Spectral, as required, in its commercialization of Toraymyxin(TM), a therapeutic hemoperfusion device for the treatment of severe sepsis. This approval permits Spectral to initiate its planned pivotal trial for Toraymyxin(TM) in the United States.

3 Mar 2010

Seattle Genetics generates $110M through ADC technology license agreements

Seattle Genetics, Inc. announced today that it has achieved a milestone under its antibody-drug conjugate (ADC) collaboration with Genentech, Inc., a wholly owned member of the Roche Group.

3 Mar 2010

PCMA releases statement on GAO report that examines specialty-tier prescription drugs in Medicare Part D

“Meaningful biogenerics legislation should be the first stop for policymakers tasked with financing health reform. PCMA and a broad coalition of consumers, employers, labor unions, and others support bipartisan legislation that would create a regulatory pathway for the Food and Drug Administration to approve generic versions of biologic products.”

3 Mar 2010

FDA releases key findings of nation's dietary habits in Health and Diet Survey

More than half of consumers in the United States often read the food label when buying a product for the first time. These consumers are also increasingly aware of the link between diet and heart disease.

3 Mar 2010

FDA's recommendations over LABAs: AANMA advises patients to make informed decisions

Allergy & Asthma Network Mothers of Asthmatics (AANMA) encourages patients to make informed decisions about recent U.S. Food and Drug Administration (FDA) recommendations affecting patients using asthma medications known as long-acting beta agonists (LABAs) or 12-hour bronchodilators: Advair, Foradil, Serevent and Symbicort.

3 Mar 2010

Merck’s MF/F Phase III study data presented at AAAAI annual meeting

Data from two Phase III studies of Merck’s investigational fixed-dose combinations of mometasone furoate and formoterol fumarate (MF/F) were presented by researchers today in two poster presentations at the American Academy of Allergy, Asthma & Immunology (AAAAI) annual meeting.

3 Mar 2010

Total economic impact of foodborne illness across the nation to be a combined $152 billion annually

A new study by a former U.S. Food and Drug Administration (FDA) economist estimates the total economic impact of foodborne illness across the nation to be a combined $152 billion annually.

3 Mar 2010

Greater use of ESAs and iron at lower hematocrit levels decrease risk of death for hemodialysis patients

Greater use of erythropoiesis-stimulating agents (ESAs) and more frequent use of iron at lower hematocrit levels (the proportion of the blood that consists of red blood cells) was associated with a decreased risk of death for hemodialysis patients, according to a study in the March 3 issue of JAMA.

3 Mar 2010

Aggressive treatment of anemia with ESAs may lower risk of death for dialysis patients: Study

Aggressive treatment of anemia with intravenous iron and drugs known as erythropoiesis-stimulating agents (ESAs) may lower the risk of death for dialysis patients with severe anemia - but also may increase the risk of death among patients with milder anemia, a new study led by a University of North Carolina at Chapel Hill epidemiologist suggests.

3 Mar 2010

PINC trial to test anti-malarial drug in women with DCIS

Can a drug that has been used to treat malaria for years possibly be used to treat breast cancer before it becomes invasive? That's what researchers at George Mason University's Center for Applied Proteomics and Molecular Medicine (CAPMM) and Inova Breast Care Institute (IBCI) are trying to prove.

3 Mar 2010

Mother's milk sends signals that affect babies' behavior and temperament

Among rhesus macaque monkeys, mothers who weigh more and have had previous pregnancies produce more and better breast milk for their babies than mothers who weigh less and are less experienced.

3 Mar 2010

Opinions: Chile's preparedness; Evangelical Christians; 'Locavorism'

The earthquake in Chile "was the fifth biggest ever measured, and several hundred times larger than the one that killed more than 220,000 in Haiti," according to a Wall Street Journal editorial. The editorial highlights Chile's preparation for earthquakes, including stricter building codes. "But such preparation is also the luxury of a prosperous country, in contrast to destitute and ill-governed Haiti.

3 Mar 2010

Junk food consumption on the rise among U. S. children

Children in the United States are snacking more than ever before on salty chips, candy and other junk food, according to a new University of North Carolina at Chapel Hill study.

3 Mar 2010

Baxter Healthcare's IIPV product recall of HomeChoice peritoneal dialysis cyclers classified as Class I recall

Baxter Healthcare Corporation announced today that the U.S. Food and Drug Administration (FDA) has classified Baxter’s recent Urgent Product Recall regarding Increased Intraperitoneal Volume (IIPV), or overfill of the abdominal cavity, associated with HomeChoice and HomeChoice Pro peritoneal dialysis cyclers as a Class I recall.

From Baxter International Inc. 3 Mar 2010

Sec. of State Clinton arrives in Chile 'to offer support' as country deals with earthquake

During a scheduled trip to Latin America, Secretary of State Hillary Rodham Clinton arrived in Chile Tuesday "to offer support" after a major earthquake struck over the weekend, Bloomberg/BusinessWeek reports (Boyd/Smith, 3/2).

3 Mar 2010

FDA issues final guidance to help develop safe and effective cell-based viral vaccines

The U.S. Food and Drug Administration today issued final guidance to help manufacturers who are developing safe and effective cell-based viral vaccines to address emerging and pandemic threats.

3 Mar 2010

Majority of consumers read food labels; skeptical of 'low fat' or 'high fiber' labels

A majority of consumers read food labels and are increasingly aware of the link between good nutrition and reducing the risk of disease, according to the latest survey of dietary habits released today by the U.S. Food and Drug Administration.

3 Mar 2010

Data demonstrating effectiveness of KALBITOR to treat acute HAE presented at AAAAI 2010 Annual Meeting

Data demonstrating the effectiveness of KALBITOR (ecallantide) to treat hereditary angioedema (HAE) acute attacks by primary attack location were provided in an oral presentation yesterday at the American Academy of Allergy, Asthma and Immunology 2010 Annual Meeting in New Orleans.

3 Mar 2010

FDA approves Mylan Pharmaceuticals' ANDA for Ursodiol Capsules

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for Ursodiol Capsules USP, 300 mg, the generic version of Watson's gastrointestinal agent Actigall® Capsules.

3 Mar 2010

Food News and Research

POZEN reports net loss of $6.9M for year ended December 31, 2009

Spectral Diagnostics receives FDA IDE approval for Toraymyxin

Seattle Genetics generates $110M through ADC technology license agreements

PCMA releases statement on GAO report that examines specialty-tier prescription drugs in Medicare Part D

FDA releases key findings of nation's dietary habits in Health and Diet Survey

FDA's recommendations over LABAs: AANMA advises patients to make informed decisions

Merck’s MF/F Phase III study data presented at AAAAI annual meeting

Total economic impact of foodborne illness across the nation to be a combined $152 billion annually

Greater use of ESAs and iron at lower hematocrit levels decrease risk of death for hemodialysis patients

Aggressive treatment of anemia with ESAs may lower risk of death for dialysis patients: Study

PINC trial to test anti-malarial drug in women with DCIS

Mother's milk sends signals that affect babies' behavior and temperament

Opinions: Chile's preparedness; Evangelical Christians; 'Locavorism'

Junk food consumption on the rise among U. S. children

Baxter Healthcare's IIPV product recall of HomeChoice peritoneal dialysis cyclers classified as Class I recall

Sec. of State Clinton arrives in Chile 'to offer support' as country deals with earthquake

FDA issues final guidance to help develop safe and effective cell-based viral vaccines

Majority of consumers read food labels; skeptical of 'low fat' or 'high fiber' labels

Data demonstrating effectiveness of KALBITOR to treat acute HAE presented at AAAAI 2010 Annual Meeting

FDA approves Mylan Pharmaceuticals' ANDA for Ursodiol Capsules

Understanding cultivated meat and its global potential eBook

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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