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Mar 30, 2014

Medtronic valve for congenital heart defects works well a year later – study

WASHINGTON, March 30 (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, and
patients typically go home after only one night in the hospital.

Mar 30, 2014

Edwards heart valve system tops Medtronic version in small study

WASHINGTON, March 30 (Reuters) – The minimally invasive
aortic heart valve replacement system from Edwards Lifesciences
Corp performed better than a rival product sold by
Medtronic Inc in the first head-to-head study of the
two, according to data from a small German trial presented at a
major heart meeting on Sunday.

The results are unlikely to be seen as decisive given the
size and limited scope of the study. But they could provide the
Edwards sales force with a valuable marketing tool as the two
companies vie for market share with their competing
transcatheter aortic valve replacement (TAVR) systems.

Mar 29, 2014

Amgen drug lowers cholesterol up to 66 percent in pivotal studies

WASHINGTON (Reuters) – Amgen Inc’s drug from a high profile new class of experimental medicines lowered “bad” LDL cholesterol by 55 percent to 66 percent compared with a placebo in a trio of late-stage clinical trials, according to data presented on Saturday.

Amgen had previously said the drug, evolocumab, met the main goals of five late-stage trials involving some 4,000 patients by significantly outperforming placebo or another cholesterol medicine in a variety of patient populations.

Mar 29, 2014

Renal denervation fails to lower blood pressure in critical test

PROVIDENCE, RI/WASHINGTON, March 29 (Reuters) – Patients
treated by renal artery denervation were no more likely to see
their blood pressure decline than those who received a fake
therapy in a major clinical trial, calling into question a
therapy used in more than 80 countries to treat hypertension
that doesn’t respond to drugs.

The study was considered a key test of the intervention in
which nerve connections between the heart and kidney were
disrupted in an effort to lower blood pressure as prior trials
did not include a blinded control group for efficacy comparison.

Mar 29, 2014

Daylight saving time linked to heart attacks: study

WASHINGTON (Reuters) – Switching over to daylight saving time, and losing one hour of sleep, raised the risk of having a heart attack the following Monday by 25 percent, compared to other Mondays during the year, according to a new U.S. study released on Saturday.

By contrast, heart attack risk fell 21 percent later in the year, on the Tuesday after the clock was returned to standard time, and people got an extra hour’s sleep.

Mar 29, 2014

Survival rate with Medtronic’s CoreValve tops surgery -study

WASHINGTON, March 29 (Reuters) – Medtronic Inc’s
minimally invasive CoreValve system for replacing diseased
aortic heart valves led to a significantly higher survival rate
after one year than traditional open heart surgery in patients
deemed at high risk of death during surgery, according to data
from a study presented on Saturday.

One year after receiving the CoreValve in the 795-patient
Phase III trial, the rate of death was 14.2 percent compared
with a 19.1 percent death rate in the surgery group, researchers
said. The result, presented at the American College of
Cardiology scientific meeting in Washington, was deemed to be
statistically significant.

Mar 29, 2014

Diet drinks raise heart concern in postmenopausal women

WASHINGTON (Reuters) – Diet drinks may increase the risk of heart attacks, stroke and other heart problems in postmenopausal women, according to an informal study that could take some fizz out of enjoyment of the popular beverages.

Compared to women who never or seldom consume diet drinks, those who drank two or more a day were 30 percent more likely to suffer a cardiovascular event and 50 percent more likely to die from related disease, researchers found.

Mar 25, 2014

India generic drugmakers’ woes put new focus on quality over price

By Bill Berkrot

(Reuters) – A spate of regulatory warnings for India’s generic drug manufacturers will add a new emphasis on the quality of such medicines in an industry long dominated by the ability to deliver treatments as cheaply as possible, analysts say.

In the short term, that is expected to benefit larger global competitors, such as Teva Pharmaceutical Industries Ltd, Actavis Plc and Mylan Inc, which will be called upon to supply drugs no longer available from some of their rivals in India, they said.

Mar 22, 2014

Experimental J&J psoriasis drug shows promise in study

By Bill Berkrot

(Reuters) – An experimental Johnson & Johnson drug for moderate to severe psoriasis proved significantly better at clearing the scaly, uncomfortable skin patches associated with the disease than a placebo, according to data from a midstage study presented on Saturday.

The J&J biologic medicine, guselkumab, achieved the main goal of the Phase II study at all five dosing regimens tested by clearing or reducing the psoriasis to a minimal measure after 16 weeks of treatment in a far greater percentage of patients than in the group that received a placebo. It also appeared to be as good as or more effective than AbbVie’s big selling Humira at four of the tested doses.

Mar 21, 2014

U.S. FDA approves Celgene drug for psoriatic arthritis

March 21 (Reuters) – U.S. health regulators on Friday
approved a Celgene Corp drug to treat psoriatic
arthritis, a type of arthritis associated with the skin disease
psoriasis that causes joint pain, stiffness and swelling.

The drug, known chemically as apremilast, will be sold under
the brand name Otezla. It is also being studied by the U.S.
biotechnology company as a treatment for psoriasis and
ankylosing spondylitis.

    • 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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