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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.

Mar 21, 2014

U.S. lawmakers ask Gilead about Sovaldi pricing

By Bill Berkrot

(Reuters) – U.S. lawmakers have asked Gilead Sciences Inc for a briefing on the price of its new hepatitis C drug Sovaldi, which some fear is too expensive at about $84,000 per patient.

A letter to Gilead from Democrats in the House Energy & Commerce Committee asks for information on Sovaldi discounts on the recently approved medicine to payors and patients.

Mar 18, 2014

Insight – Unease grows among U.S. doctors over Indian drug quality

WASHINGTON/NEW YORK (Reuters) – Some U.S. doctors are becoming concerned about the quality of generic drugs supplied by Indian manufacturers following a flurry of recalls and import bans by the Food and Drug Administration.

India supplies about 40 percent of generic and over-the-counter drugs used in the United States, making it the second-biggest supplier after Canada.

Mar 18, 2014

Unease grows among U.S. doctors over Indian drug quality

WASHINGTON/NEW YORK, March 18 (Reuters) – Some U.S. doctors
are becoming concerned about the quality of generic drugs
supplied by Indian manufacturers following a flurry of recalls
and import bans by the Food and Drug Administration.

India supplies about 40 percent of generic and
over-the-counter drugs used in the United States, making it the
second-biggest supplier after Canada.

Mar 14, 2014

Amgen vaccine triggers immune response in advanced melanoma -study

By Bill Berkrot

(Reuters) – An experimental Amgen Inc cancer vaccine used to treat advanced melanoma, the deadliest form of skin cancer, proved effective in a late-stage study in shrinking tumors in a way that suggests the drug triggered the intended systemic immune response, according to data presented on Friday.

The vaccine shrank tumors that were directly injected with the drug and tumors around the body that were not injected, according to the data.

Mar 4, 2014

Merck says dust mite allergy drug reduces symptoms in midstage study

March 4 (Reuters) – An immunotherapy pill to treat an
allergy to house dust mites being tested by Merck & Co
significantly reduced common nasal symptoms, such as sneezing
and stuffy nose, according to data from a midstage clinical
trial, the company said on Tuesday.

The drug, MK-8237, reduced nasal symptoms by 49 percent at
the higher tested dose and 27 percent at the lower dose compared
with a placebo after 24 weeks of treatment. The results, which
were deemed to be statistically significant, were presented on
Tuesday at the American Academy of Allergy, Asthma and
Immunology (AAAAI) meeting in San Diego.

    • 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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