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FDA approves Creon (pancrelipase) - designed to help those with cystic fibrosis

The U.S. Food and Drug Administration announced that it has approved Creon (pancrelipase), a pancreatic enzyme replacement product designed to help patients with cystic fibrosis and others with exocrine pancreatic insufficiency (EPI) digest and absorb nutrients from foods.

7 May 2009

Safety concerns over testosterone gel prompt FDA to require label changes

The U.S. Food and Drug Administration today announced that it is requiring manufacturers of two prescription topical testosterone gel products, AndroGel 1% and Testim 1%, to include a boxed warning on the products' labels.

7 May 2009

2010 budget for FDA invests substantially in food and medical product safety

The U.S. Food and Drug Administration, part of the U.S. Department of Health and Human Services, is requesting a budget of $3.2 billion to protect and promote the public health as part of the President's fiscal year (FY) 2010 budget - a 19 percent increase over the current FDA fiscal year budget.

7 May 2009

Pandemic influenza preparedness in Latin America: analysis of national strategic plans, health policy and planning

An analysis of pandemic preparedness plans from Latin American countries has indicated that although most now have national strategic plans in place, it is the wealthiest countries that tend to have the most complete plans.

7 May 2009

Merck Serono starts second phase III trial of Safinamide in advanced Parkinson's

Merck Serono announced today the initiation of the SETTLE study. This study will evaluate the efficacy and safety of a dose range of safinamide (50-100 mg once daily) as add-on therapy to a stable dose of levodopa, in mid- to late-stage Parkinson's disease patients with motor fluctuations compared to placebo.

7 May 2009

FDA approve Fanapt tablets (iloperidone) to treat adults with schizophrenia

The U.S. Food and Drug Administration has approved Fanapt tablets (iloperidone) to treat adults with schizophrenia, a chronic, severe and disabling brain disorder.

7 May 2009

Anti-clotting action of clopidogrel (Plavix) reduced by common heartburn drugs

The anti-clotting action of the medication clopidogrel (Plavix) can be compromised by common drugs for the treatment of heartburn and ulcers resulting in a roughly 50% increase in the combined risk of hospitalization for heart attack, stroke and other serious cardiovascular illnesses, according to a new study presented today at the Society for Cardiovascular Angiography and Interventions (SCAI) 32nd Annual Scientific Sessions.

6 May 2009

Discovery of gene key to Alzheimer's-like reversal

A team led by researchers at MIT's Picower Institute for Learning and Memory has now pinpointed the exact gene responsible for a 2007 breakthrough in which mice with symptoms of Alzheimer's disease regained long-term memories and the ability to learn

6 May 2009

Three genes play a role in breast cancer's spread to the brain

New research led by investigators at Memorial Sloan-Kettering Cancer Center (MSKCC) identifies three genes that specifically mediate the metastasis, or spread, of breast cancer to the brain and illuminates the mechanisms by which this spread occurs. The study was published online today in Nature.

6 May 2009

Swine flu: Action and response from the Cochrane Library

Fears about Swine Flu and notions of the best methods of preventing the spread are sweeping over the world like wild fire, with everyone voicing a different opinion. Is stocking Tamiflu the best option? Do facemasks work? Should we be constantly washing our hands, or never leaving the house?

6 May 2009

Panic buying of flu drug results in rationing

Even though Australia is yet to have had any confirmed cases of influenza A H1N1 (swine flu) there has been such a demand for the anti-viral drug Tamiflu that the drug must now be rationed - it is reported that in the last week 120,000 courses of Tamiflu were sold, compared with about 10,000 courses in a normal flu season and many chemists have run out.

6 May 2009

IBM and University of Texas Medical Branch launch effort to find flu drug treatments

IBM and the University of Texas Medical Branch (UTMB) launched an effort using IBM's World Community Grid "virtual supercomputer" to allow laboratory tests on drug candidates for drug-resistant influenza strains and new strains, such as H1N1, in less than a month.

6 May 2009

New antidepressants might be no more effective than the best existing drugs

The reviews suggest that sertraline - sold under the brand name Zoloft since 1991- could be the best initial choice of antidepressant in people with acute major depression. The generic formulation produced the best balance of effectiveness, tolerability and purchase price, the authors say.

5 May 2009

Off-label uses of drugs should be approved for very ill patients, opinion piece states

FDA and Congress "should protect physicians' and patients' right" to use FDA-approved drugs for off-label uses "and for the first time allow drugmakers to promote off-label uses that prove beneficial," Richard Epstein, a law professor at the University of Chicago and a senior fellow at the Hoover Institution, writes in a Wall Street Journal opinion piece. He continues, "Right now these drugs provide immense lifesaving opportunities for many sick patients, particularly those threatened by cancer."

5 May 2009

Mental health prescriptions increased by 73% among adults, 50% among children from 1996-2006

From 1996 to 2006, prescriptions for mental health medications increased by 73% among U.S. adults and by 50% among children, according to a study published on Tuesday in the journal Health Affairs, the Wall Street Journal reports.

5 May 2009

High health care costs affecting insured U.S. residents

Across the country, 64 million people younger than age 65 are part of families spending more than 10% of their pretax income on health care, according to a Families USA study, the Boston Globe reports.

5 May 2009

Senate HELP Committee moves up FDA Commissioner-Designate Hamburg's confirmation hearing due to H1N1 outbreak

The Senate Health, Education, Labor and Pensions Committee has moved to Thursday the confirmation hearing for Margaret Hamburg, President Obama's pick for FDA commissioner, citing the need to address the H1N1 influenza outbreak, the Wall Street Journal reports.

5 May 2009

HIV-positive people worldwide at increased risk of the H1N1 flu

HIV-positive people worldwide are at an increased risk of the H1N1 flu strain, the World Health Organization said on Saturday in guidelines for health workers published on its Web site, Reuters India reports.

5 May 2009

Elevated level of certain protein in urine linked to increased risk for blood clots

Preliminary research suggests that higher than normal levels of the protein albumin in urine is associated with an increased risk for blood clots in the deep veins of the legs or lungs (venous thromboembolism; VTE), according to a study in the May 6 issue of JAMA, the Journal of the American Medical Association.

5 May 2009

Study shows beneficial effects statins may have on gastrointestinal disorders

The commonly used prescription statin drugs may have a protective effect in the prevention of liver cancer and lead to a reduction in the need for gallbladder removals, according to two studies published in Gastroenterology.

5 May 2009

Drugs News and Research

FDA approves Creon (pancrelipase) - designed to help those with cystic fibrosis

Safety concerns over testosterone gel prompt FDA to require label changes

2010 budget for FDA invests substantially in food and medical product safety

Pandemic influenza preparedness in Latin America: analysis of national strategic plans, health policy and planning

Merck Serono starts second phase III trial of Safinamide in advanced Parkinson's

FDA approve Fanapt tablets (iloperidone) to treat adults with schizophrenia

Anti-clotting action of clopidogrel (Plavix) reduced by common heartburn drugs

Discovery of gene key to Alzheimer's-like reversal

Three genes play a role in breast cancer's spread to the brain

Swine flu: Action and response from the Cochrane Library

Panic buying of flu drug results in rationing

IBM and University of Texas Medical Branch launch effort to find flu drug treatments

New antidepressants might be no more effective than the best existing drugs

Off-label uses of drugs should be approved for very ill patients, opinion piece states

Mental health prescriptions increased by 73% among adults, 50% among children from 1996-2006

High health care costs affecting insured U.S. residents

Senate HELP Committee moves up FDA Commissioner-Designate Hamburg's confirmation hearing due to H1N1 outbreak

HIV-positive people worldwide at increased risk of the H1N1 flu

Elevated level of certain protein in urine linked to increased risk for blood clots

Study shows beneficial effects statins may have on gastrointestinal disorders

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