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Mar 11, 2013

Edwards heart valve system good as surgery at three years: trial

SAN FRANCISCO (Reuters) – Patients who received the original version of Edwards Lifesciences Corp’s non-invasive heart valve replacement system had a nearly identical death rate after three years as those who had open-heart surgery, with no increased risk of stroke, according to results from a clinical trial.

The data, presented on Monday at the American College of Cardiology scientific meeting in San Francisco, should provide doctors with some reassurance about the durability of the Edwards transcatheter aortic valve replacement (TAVR), known as Sapien.

Mar 11, 2013

Edwards heart valve system good as surgery at 3 years-trial

SAN FRANCISCO, March 11 (Reuters) – Patients who received
the original version of Edwards Lifesciences Corp’s
non-invasive heart valve replacement system had a nearly
identical death rate after three years as those who had
open-heart surgery, with no increased risk of stroke, according
to results from a clinical trial.

The data, presented on Monday at the American College of
Cardiology scientific meeting in San Francisco, should provide
doctors with some reassurance about the durability of the
Edwards transcatheter aortic valve replacement (TAVR), known as
Sapien.

Mar 10, 2013

Gilead drug reduces chest pain episodes in diabetics: study

SAN FRANCISCO (Reuters) – Gilead Sciences Inc’s angina drug Ranexa reduced incidents of chest pain in patients with diabetes, and the effect appeared to be more pronounced in those with poor blood sugar control, according to data from a clinical trial.

Ranexa, known chemically as ranolazine, is already approved to treat angina – a type of chest pain associated with heart disease. This was the first trial to test it specifically in diabetics, who tend to have more complications and can be more difficult to treat that other heart patients.

Mar 10, 2013

Experimental Roche drug shows promise in reducing heart damage

SAN FRANCISCO (Reuters) – A single dose of an experimental Roche biotech drug that blocks inflammation reduced damage to the heart during artery clearing angioplasty procedures, according to data from a midstage trial presented on Sunday.

The drug, inclacumab, was significantly better than a placebo in decreasing levels of molecular markers, or enzymes, that are used to diagnose heart attacks and heart damage in patients also taking standard drugs, such as cholesterol lowering statins, researchers said.

Mar 10, 2013

Medicines Co’s Cangrelor clearly tops Plavix in pivotal trial

SAN FRANCISCO (Reuters) – The Medicines Co’s experimental intravenous blood clot preventer Cangrelor, which is intended for use during angioplasty procedures, solidly outperformed commonly used Plavix in a pivotal late stage study, likely resurrecting the drug’s prospects.

The aptly named Champion-Phoenix trial, with 11,000 patients undergoing an angioplasty and stenting procedure, was meant to save the potentially important new medicine from the ashes of a pair of prior Phase III studies in which it failed to achieve the primary goal.

Mar 10, 2013

Redesigned Edwards heart valve system shows improvement in study

SAN FRANCISCO (Reuters) – A smaller, redesigned version of Edwards Lifesciences’ non-invasive heart valve replacement system called Sapien XT performed well and led to fewer complications than the original Sapien, according to data from a clinical trial presented on Sunday.

Both versions, known as transcatheter aortic valve replacements (TAVR), allow surgeons to replace diseased heart valves by threading the new valve into place through an artery via a catheter, sparing patient’s chest cracking, open heart surgery.

Mar 9, 2013

Serious side effects seen with failed Merck niacin drug

SAN FRANCISCO, March 9 (Reuters) – Unexpected serious side
effects arose in a huge study of a Merck & Co
long-acting niacin drug aimed at raising good HDL cholesterol,
according to data released on Saturday, possibly adding another
nail to the coffin of niacin therapy for heart patients.

Merck has already given up on the drug that combines
extended-release niacin with an experimental agent called
laropiprant, designed to prevent the uncomfortable facial
flushing associated with niacin.

Mar 9, 2013

Serious side effects seen with failed Merck niacin drug: study

By Bill Berkrot

(Reuters) – Unexpected serious side effects arose in a huge study of a Merck & Co long-acting niacin drug aimed at raising good HDL cholesterol, according to data released on Saturday, possibly adding a final nail to the coffin of niacin therapy for heart patients.

Merck has already given up on the drug that combines extended-release niacin with an experimental agent called laropiprant, designed to prevent the uncomfortable facial flushing associated with niacin.

Mar 6, 2013

Analyst says Dendreon recommendation “worst” of career, apologizes

By Bill Berkrot

(Reuters) – Wall Street analysts aren’t known to apologize for giving bad advice on stocks, much less admit they’ve made the worst call of their entire careers.

But that’s exactly what happened on Wednesday, when a well-known biotechnology industry analyst apologized for getting it wrong on Dendreon Corp (DNDN.O: Quote, Profile, Research, Stock Buzz), after the company’s latest caution on sales of the prostate cancer drug Provenge.

Mar 2, 2013

Celgene drug shown to be effective, safe in psoriasis trial

By Deena Beasley and Bill Berkrot

(Reuters) – Celgene Corp’s experimental drug apremilast proved to be more effective than a dummy pill for psoriasis patients in a late-stage study, clearing the way for the company to file for U.S. regulatory approval in the second half of 2013.

Celgene said 59 percent of patients in the 844-patient trial achieved a 50 percent improvement in symptoms at 16 weeks, using a standard score of the severity and extent of psoriasis, compared with 17 percent of placebo patients. A 75 percent improvement in symptoms was seen in 33 percent of the treatment group and 5 percent of the placebo group.

    • 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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