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Nov 12, 2013

New heart guidelines back stronger therapies for high risk patients

By Bill Berkrot

(Reuters) – New U.S. guidelines on heart health that were a decade in the making recommend stronger measures for patients at particularly high risk of heart attack or stroke, including more aggressive therapy with drugs that lower cholesterol or even bariatric weight loss surgery.

The guidelines issued by two leading U.S. medical organizations on Tuesday are likely to be followed by cardiologists and primary care physicians, as well as influence insurance coverage. They still emphasize a healthy diet and exercise as keys to avoiding the No. 1 killer in the country.

Nov 7, 2013

New Roche leukemia drug shows clear advantage over Rituxan-study

Nov 7 (Reuters) – Roche’s newly approved leukemia
drug Gazyva helped patients live nearly a year longer without
the disease worsening than the drugmaker’s top-selling Rituxan
in a head-to-head trial that should help fend off competition
from cheaper versions of the older medicine.

Gazyva, previously known as GA101, was approved in the
United States last week as an initial treatment for patients
with chronic lymphocytic leukemia, or CLL, one of the most
common forms of blood cancer. It is awaiting approval decisions
in Europe and other markets.

Nov 2, 2013

Bristol seeks Japan approval of all-oral hepatitis C treatment

By Bill Berkrot

(Reuters) – Bristol-Myers Squibb Co has filed with Japanese health regulators seeking approval of its experimental all-oral combination of hepatitis C treatments, the U.S. drugmaker said on Saturday.

The submission with Japan’s Pharmaceutical and Medical Devices Agency marks the first time that any drugmaker has filed for approval of a hepatitis C treatment regimen that does not include either of the standard older treatments – the injected, difficult-to-tolerate interferon, or ribavirin, a pill.

Nov 2, 2013

High cure rates seen with Merck oral hepatitis drugs: study

By Bill Berkrot

(Reuters) – A combination of two oral hepatitis C treatments developed by Merck & Co led to high cure rates in previously untreated patients, indicating the company is a contender in the race to find new treatments for the liver destroying virus.

The treatments tested with and without the older drug ribavirin led to cure rates of 96 percent to 100 percent, according to interim data from a small midstage clinical trial.

Oct 30, 2013

PerkinElmer narrows 2013 forecast, cites Q4 uncertainty

Oct 30 (Reuters) – Scientific instruments maker PerkinElmer
Inc narrowed its full-year earnings forecast range on
Wednesday, lowering the top end by 3 cents, as it takes a
cautious view on business for the rest of the year.

The company also reported slightly higher-than-expected
third-quarter profit and revenue.

Oct 30, 2013

Medicines Co blood thinner cuts death risk in European ambulance trial

By Bill Berkrot

(Reuters) – Medicines Co’s blood thinner Angiomax, when administered en route to the hospital to patients suffering a serious heart attack, significantly reduced the risk of major bleeding and death compared with commonly used heparin, according to data from a large clinical trial.

However, those who got Angiomax in the 2,198-patient study had a far higher risk of suffering acute stent thrombosis, or blood clots forming within 24 hours at the site of devices used to prop open previously clogged arteries, researchers found.

Oct 28, 2013

Biogen’s new MS drug tops expectations; earnings rise

By Bill Berkrot

(Reuters) – Biogen Idec Inc on Monday reported $286 million in third-quarter sales of its high-profile new multiple sclerosis drug Tecfidera, providing fresh evidence that the medicine is off to an impressive launch and exceeding expectations.

The company also reported higher-than-expected third quarter earnings and raised its full year profit and revenue forecasts, and its shares rose more than 3 percent.

Oct 26, 2013

Celgene arthritis drug appears effective, safe after one year: study

By Bill Berkrot

(Reuters) – Previously untreated patients experienced significant and lasting reductions in signs and symptoms of psoriatic arthritis when given Celgene Corp’s experimental oral drug, apremilast, according to data from a late stage clinical trial.

Patients taking either the 20 milligrams or 30 mg dose of apremilast twice a day had a statistically significant improvement in symptoms, such as painful, swollen joints, after 16 weeks of treatment compared with those who received a placebo, researchers said.

Oct 25, 2013

FDA approves Abbott device for leaking heart valve

By Bill Berkrot

(Reuters) – The U.S. Food and Drug Administration has approved Abbott Laboratories’ MitraClip medical device, used to stop heart valve leakage in patients deemed unable to endure valve repair through open heart surgery, the company said on Friday.

The MitraClip treats mitral regurgitation, a condition in which the mitral valve of the heart does not close properly, causing blood leakage that can lead to stroke, heart attack or even death.

Oct 24, 2013

Celgene raises 2013 forecast as profit beats estimates

Oct 24 (Reuters) – Celgene Corp raised its earnings
forecast for 2013 on Thursday after reporting slightly
higher-than-expected quarterly profit on robust sales of its
flagship blood cancer drug Revlimid and solid growth in newer
cancer treatments.

Still, the company’s net profit fell amid higher expenses
for product launches and clinical trials.

    • 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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