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Apr 12, 2014

Intercept’s liver disease drug proves highly effective in study

By Bill Berkrot

(Reuters) – A drug being developed by Intercept Pharmaceuticals Inc led to significant improvement in signs of a rare liver disease that primarily affects middle-aged women, likely reducing the risk of need for liver transplant and of death, according to results of a late-stage clinical trial presented on Saturday.

Nearly half the patients suffering from primary biliary cirrhosis who received the drug, obeticholic acid, achieved the primary goals of the study, compared with 10 percent for those who received a placebo, researchers said.

Apr 10, 2014

Bristol-Myers hepatitis C treatment cures up to 90 percent: study

By Bill Berkrot

(Reuters) – A combination of two anti-viral drugs developed by Bristol-Myers Squibb Co cured 90 percent of previously untreated hepatitis C patients and 82 percent of those who failed to respond to prior therapy, according to results from a late stage study presented on Thursday.

The Phase III trial of more than 700 patients called Hallmark-Dual tested a combination of Bristol’s daclatasvir and asunaprevir over 24 weeks of therapy in patients with genotype 1b of the virus that causes progressive liver disease.

Apr 10, 2014

Merck hepatitis C drugs shine in easier to treat patients -study

April 10 (Reuters) – A two-drug combination being tested by
Merck & Co to treat hepatitis C cured 98 percent of
previously untreated patients without cirrhosis in a midstage
clinical trial, providing the latest evidence that the U.S.
drugmaker will be highly competitive in the fast evolving field.

Results of the study called C-Worthy were presented on
Thursday at the annual meeting of the European Association for
the Study of the Liver (EASL) in London. Researchers are due on
Friday to present results of how the Merck pills fared in more
difficult to treat patients, such has those who failed to be
helped by prior treatments and those with more advanced liver
disease.

Apr 9, 2014

Exclusive: Heart docs seek curbs on kidney-zapping hypertension devices

By Ransdell Pierson and Bill Berkrot

(Reuters) – Several leading U.S. and European heart doctors are calling for curbs, or even a moratorium, on using devices meant to lower blood pressure by zapping kidney arteries, following a surprising failure of the technology in a clinical trial.

The views highlight a significant new hurdle to wider approval and acceptance of the therapy, known as renal denervation, which had raised hopes in the medical community as a way to treat stubbornly high blood pressure for patients who don’t gain enough benefit from drugs.

Apr 6, 2014

Agios leukemia drug shows promise in tiny, early study

By Bill Berkrot

(Reuters) – An experimental drug being developed by Agios Pharmaceuticals Inc showed promising anti-cancer activity in a tiny Phase I study of patients with relapsed acute myeloid leukemia (AML), according to data presented on Sunday.

Of seven patients available to be evaluated following a 28-day cycle of treatment with the drug, AG-221, six had what researchers deemed objective responses to the medicine.

Mar 31, 2014

Weight loss surgery helps many reverse type 2 diabetes – study

WASHINGTON (Reuters) – Bariatric weight loss surgery on obese patients with type 2 diabetes helped many get their blood sugar to healthy levels and to no longer require any diabetes medicines, including insulin, three years after the procedure, according to data presented at a major medical meeting on Monday.

The surgery also helped patients reduce the need for high blood pressure and cholesterol medicines and led to quality of life improvements compared with those who received medical weight-loss therapy, researchers found.

Mar 31, 2014

Steroids shown to hurt, not help, patients in bypass surgery

WASHINGTON (Reuters) – A longstanding practice of giving steroids to patients during cardiopulmonary bypass surgery to reduce inflammation failed to help patients and actually increased the risk of heart attacks, according to results of a large clinical trial.

“This study shows that administering steroids during cardiac surgery requiring bypass can cause harm,” said Dr. Richard Whitlock, a cardiologist with McMaster University in Hamilton, Ontario, who led the international trial. “Based on these results, we suggest that steroids should not be used prophylactically during cardiac surgeries that require the use of cardiopulmonary bypass.”

Mar 31, 2014

Weight loss surgery helps reverse type 2 diabetes for some -study

WASHINGTON, March 31 (Reuters) – Bariatric weight loss
surgery on obese patients with type 2 diabetes helped many to
get their blood sugar to healthy levels and to no longer require
any diabetes medicines, including insulin, three years after the
procedure, according to data presented at a major medical
meeting on Monday.

The surgery also helped patients reduce the need for high
blood pressure and cholesterol medicines and led to quality of
life improvements compared with those who received medical
weight-loss therapy, researchers found.

Mar 30, 2014

Medtronic valve for heart defects works well a year later: study

WASHINGTON (Reuters) – A non-surgically implanted heart valve meant to delay open heart surgery in children with congenital heart defects worked well for all but a few patients during a year of follow-up observation, in line with favorable results seen in original clinical trials of the Medtronic Inc product.

The Melody transcatheter pulmonary valve was approved in 2010 under a U.S. humanitarian device exemption, which allowed it on the market as long as a follow-up study was conducted to assess the product’s reliability and safety. The valve is guided to the heart by a catheter, a minimally invasive procedure.

Mar 30, 2014

Glaxo heart drug that failed trial shows potential benefit

WASHINGTON (Reuters) – A new type of heart drug being developed by GlaxoSmithKline, which failed the main goal of a Phase III study of patients with chronic but well-treated heart disease, showed signs of potential benefit, the trial’s co-leader said.

The results presented at the American College of Cardiology scientific meeting in Washington on Sunday provided a glimmer of hope that the medicine, darapladib, may have value.

    • 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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