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Nov 19, 2013

Amgen cholesterol drug appears safe, cut LDL 52 pct at 1 year-study

DALLAS, Nov 19 (Reuters) – Amgen Inc’s experimental
heart medicine from a closely watched new class of drugs called
PCSK9 inhibitors lowered “bad” LDL cholesterol 52 percent after
one year with no major increase in serious adverse side effects
compared with standard drugs, such as statins, according to data
from a study.

The clinical trial of the drug, evolocumab, marks the first
data looking at 52 weeks of use for the new class of injectable
biotech medicines seen as potentially the biggest advance in the
field of cholesterol therapy in many years.

Nov 19, 2013

Gene analysis fails to help predict best warfarin dose

By Ransdell Pierson and Bill Berkrot

(Reuters) – Gene analysis failed in a U.S. clinical trial to help doctors select better doses of warfarin, the widely used blood-thinner, which can cause dangerous bleeding if doses are too high and fail to protect against blood clots and strokes if doses are too low.

Warfarin, an oral drug that has been on the market for more than 60 years, is used to prevent strokes in people with an irregular heartbeat called atrial fibrillation and to prevent dangerous blood clots in veins and in the lungs.

Nov 19, 2013

Daiichi blood thinner safer, as effective as warfarin -study

DALLAS, Nov 19 (Reuters) – A new blood clot and stroke
preventer from Daiichi Sankyo proved as effective and
safer than widely used warfarin in a large, late stage trial of
patients with atrial fibrillation, paving the way for it to
compete with other new warfarin alternatives on the market.

The drug, edoxaban, met the main efficacy and safety goals
of the study by demonstrating “non-inferiority” to warfarin in
preventing strokes and blood clots and led to significantly less
major bleeding – the greatest danger of blood thinning
medicines.

Nov 19, 2013

Daiichi blood thinner safer, as effective as warfarin in major study

DALLAS (Reuters) – A new blood clot and stroke preventer from Daiichi Sankyo proved as effective and safer than widely used warfarin in a large, late stage trial of patients with atrial fibrillation, paving the way for it to compete with other new warfarin alternatives on the market.

The drug, edoxaban, met the main efficacy and safety goals of the study by demonstrating “non-inferiority” to warfarin in preventing strokes and blood clots and led to significantly less major bleeding – the greatest danger of blood thinning medicines.

Nov 18, 2013

Heart guidelines authors defend method of calculating risk

Dallas (Reuters) – Top cardiologists who devised new U.S. guidelines for reducing risk of heart disease strenuously defended their risk-calculation tool from criticism that it greatly overestimates health risks and the need to be treated with statins.

Two Harvard professors, Dr. Paul Ridker and Dr. Nancy Cook, sparked the controversy by saying the guidelines overestimate risk of developing heart disease up to 150 percent for some populations, according to a report in Monday’s New York Times. The report said their criticisms would appear Tuesday in the British medical journal The Lancet.

Nov 18, 2013

New smarter Medtronic pacemaker may cut future heart damage: study

DALLAS (Reuters) – A new generation of Medtronic Inc’s EnRhythm pacemaker programmed to kick in only when heart rhythm disturbances are detected led to fewer deaths, hospitalizations and incidences of developing permanent heart problems than traditional versions of the device, according to data from a study.

The enhanced pacing strategy had its most profound effect in cutting the risk of developing permanent atrial fibrillation – a dangerously irregular heartbeat – by 61 percent over the traditional pacemakers.

Nov 18, 2013

Pradaxa antidote works fast, completely in small trial

Dallas, Nov 18 (Reuters) – An experimental antidote to the
widely used blood clot preventer Pradaxa worked immediately and
completely in an early-stage trial among healthy volunteers,
raising hopes that the drug’s blood-thinning effects can be
reversed in emergency situations.

“These are absolutely exciting findings,” said Dr. Stephan
Glund, a research executive of privately held Boehringer
Ingelheim Pharmaceuticals, the German drugmaker that developed
Pradaxa and is testing the antidote.

Nov 17, 2013

New effort launched to personalize medicine in heart treatment

Dallas, Nov 17 (Reuters) – Cardiologists are taking aim at
treating and preventing heart disease, the world’s No. 1 killer,
with a more personalized approach under a new research
collaboration that will marry data with the evolving
understanding of genetics.

The effort, being billed as Heart Studies v2.0 and which was
announced on Sunday, will be a collaboration of the American
Heart Association (AHA) along with Boston University and the
University of Mississippi, which oversee ongoing landmark
population studies, the Framingham Heart Study and the Jackson
Heart Study, respectively.

Nov 17, 2013

Childhood cancer survivors face heart risks soon after treatment

DALLAS (Reuters) – Children who survive cancer treatment face increased heart health risk and should take measures soon after life-saving therapy to reduce the risk of serious problems later in life, according to research presented at a major medical meeting.

The five-year survival rate from childhood cancer has soared from 58 percent in 1975 to 1977, to 83 percent in the period from 2003 to 2009.

Nov 13, 2013

U.S. FDA approves J&J, Pharmacyclics lymphoma drug

Nov 13 (Reuters) – U.S. health regulators on Wednesday
approved a drug to treat a rare and aggressive form of
non-Hodgkin lymphoma developed by Johnson & Johnson and
Pharmacyclics Inc, becoming the second drug that had
received the FDA’s new breakthrough therapy designation to gain
approval.

The drug, to be sold under the brand name Imbruvica, and
known chemically as ibrutinib, was approved to treat mantle cell
lymphoma in patients who have received prior treatment with at
least one other medicine, such as Celgene Corp’s
Revlimid. It works by inhibiting an enzyme needed by the cancer
to multiply and spread.

    • 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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