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Dec 2, 2013

FDA to promote use of registered drug compounders under new law

By Bill Berkrot

(Reuters) – U.S. health officials are hopeful that hospitals and other healthcare providers will show sufficient preference for using drug compounders that sign up for regulatory scrutiny under a new law that potentially risky medicines will no longer be supplied by unregistered compounding pharmacies.

The law was spurred by the deadly outbreak of fungal meningitis last year that killed 64 Americans and sickened more than 700 due to contaminated injections made and shipped by a Massachusetts drug compounder that was not under the oversight of the Food and Drug Administration.

Nov 28, 2013

Cardiologists strongly back Obamacare, worry over rocky start

DALLAS (Reuters) – American cardiologists appear staunch in their support for President Barack Obama’s healthcare reform, although some fear that its rocky launch could derail efforts to improve preventive care for needy patients.

The broad support for the Affordable Care Act, popularly known as Obamacare, emerged in interviews last week in Dallas with more than 20 cardiologists at the annual scientific sessions of the American Heart Association. The group has set an aggressive goal of reducing heart disease and deaths from heart disease and strokes in the United States by 20 percent by 2020.

Nov 27, 2013

Higher clot risk seen with Thoratec heart pump -study

Nov 27 (Reuters) – Researchers have found a higher rate of
dangerous blood clots in patients who received Thoratec Corp’s
HeartMate II heart pump than had been seen in clinical trials or
prior experience, according to a study published on Wednesday.

They also found that when blood clots do develop, they are
occurring closer to the time of HeartMate implantation than had
been previously observed. The findings were reported in the New
England Journal of Medicine.

Nov 27, 2013

Clot risk higher than previously seen with Thoratec heart pump: study

By Bill Berkrot

(Reuters) – Researchers have found a higher rate of dangerous blood clots forming in patients who received Thoratec Corp’s HeartMate II heart pump than had been seen in clinical trials or prior experience, according to a study published on Wednesday.

They also found that when blood clots do develop, they are occurring closer to the time of HeartMate implantation than had been previously observed. The findings were reported in the New England Journal of Medicine.

Nov 25, 2013

FDA lifts constraints on Glaxo diabetes drug Avandia

By Bill Berkrot and Ransdell Pierson

(Reuters) -Health regulators said on Monday they would lift restrictions on the use of GlaxoSmithKline Plc’s once widely prescribed diabetes drug Avandia, after determining that it did not increase the risk of heart attacks.

The U.S. Food and Drug Administration, following its review of a large clinical trial aimed at determining the drug’s heart safety called Record, said it found that the trial showed no elevated risk of heart attack or death in patients being treated with Avandia when compared with standard-of-care diabetes drugs.

Nov 25, 2013

FDA lifts restrictions on Glaxo diabetes drug Avandia

By Bill Berkrot and Ransdell Pierson

(Reuters) -Health regulators said on Monday they would lift restrictions on the use of GlaxoSmithKline Plc’s once widely prescribed diabetes drug Avandia, after determining that it did not increase the risk of heart attacks.

The U.S. Food and Drug Administration, following its review of a large clinical trial aimed at determining the drug’s heart safety called Record, said it found that the trial showed no elevated risk of heart attack or death in patients being treated with Avandia when compared with standard-of-care diabetes drugs.

Nov 20, 2013

Smokers who quit may cut heart risk faster than had been thought

DALLAS, Nov 20 (Reuters) – Some cigarette smokers over 65
years old who kick the habit may be able to reduce their risk of
dying from heart-related problems to the level of those who
never smoked far faster than previously believed, according to
new research presented on Wednesday.

Previous research found that older former smokers who had
consumed less than 32 pack years of cigarettes could reduce
their risk of dying from heart disease to the level of lifelong
nonsmokers after 15 years.

Nov 20, 2013

New Daiichi drug succeeds in major study; set to face rivals

DALLAS (Reuters) – A new blood clot and stroke preventer from Daiichi Sankyo proved as effective and safer than widely used warfarin in a large, late stage trial of patients with atrial fibrillation, paving the way for it to compete with other new warfarin alternatives on the market.

The drug, edoxaban, met the main efficacy and safety goals of the study by demonstrating “non-inferiority” to warfarin in preventing strokes and blood clots and led to significantly less major bleeding – the greatest danger of blood thinning medicines.

Nov 19, 2013

Signs of ‘sudden’ cardiac death may come weeks before -study

Nov 18 (Reuters) – Signs of approaching “sudden” cardiac
arrest, an electrical malfunction that stops the heart, usually
appear at least a month ahead of time, according to a study of
middle-age men in Portland, Oregon.

“We’re looking at how to identify the Tim Russerts and Jim
Gandolfinis – middle aged men in their 50s who drop dead and we
don’t have enough information why,” said Sumeet Chugh, senior
author of the study and associate director for genomic
cardiology at the Cedars-Sinai Heart Institute in Los Angeles.

Nov 19, 2013

Amgen cholesterol drug appears safe, cut LDL 52 percent at 1 year: study

DALLAS (Reuters) – Amgen Inc’s experimental heart medicine from a closely watched new class of drugs called PCSK9 inhibitors lowered “bad” LDL cholesterol 52 percent after one year with no major increase in serious adverse side effects compared with standard drugs, such as statins, according to data from a study.

The clinical trial of the drug, evolocumab, marks the first data looking at 52 weeks of use for the new class of injectable biotech medicines seen as potentially the biggest advance in the field of cholesterol therapy in many years.

    • About Bill

      "Based in New York, I primarily cover the pharmaceutical and biotechnology sectors as well as other publicly traded companies involved in health care. Previously covered a wide range of sports for Reuters."
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