Dec 10 (Reuters) – AbbVie Inc’s all-oral hepatitis
C therapy cured 96 percent of difficult-to-treat patients in a
late-stage clinical trial after 12 weeks, keeping the company
well placed in a highly competitive race to deliver new
treatments for the serious liver disease.
The study of 394 patients with the most common Genotype 1
version of the virus tested the AbbVie regimen in people who had
failed to be cured by the older standard treatments of
pegylated interferon and ribavirin.
Dec 9 (Reuters) – An advisory panel of medical experts on
Monday voted to recommend that U.S. health regulators approve an
experimental drug for ulcerative colitis and Crohn’s disease
developed by Takeda Pharmaceutical Co.
The panel voted by wide margins that the benefits outweigh
the risks of the biotech drug, vedolizumab, and advised the Food
and Drug Administration to approve it for both ulcerative
colitis and Crohn’s disease in patients who have not been helped
by prior therapies.
Dec 9 (Reuters) – Most newly diagnosed patients with the
blood cancer multiple myeloma had a very strong response to an
experimental oral drug being developed by Takeda Pharmaceutical
Co when given in combination with standard treatments,
according to data from a study presented on Monday.
Overall, 94 percent of the 62 patients in the Phase I/II
trial had their cancer respond to Takeda’s MLN9708 taken twice a
week in combination with Celgene Corp’s Revlimid and
the corticosteroid dexamethasone.
By Bill Berkrot
(Reuters) – A closely watched leukemia drug developed by Johnson & Johnson and Pharmacyclics Inc maintained its effectiveness in keeping the disease at bay for most patients, according to long-term follow-up data from a midstage study being presented at a major medical meeting.
The oral drug, ibrutinib, last month won U.S. approval to treat a rare and aggressive form of non-Hodgkin lymphoma known as mantle cell lymphoma. It is awaiting a Food and Drug Administration decision on treating chronic lymphocytic leukemia (CLL), a slowly progressing form of blood cancer that primarily affects people aged 65 and older.
NEW YORK (Reuters) – Global drugmaker Pfizer Inc will broaden access to information from its scores of clinical trials to independent researchers and to patients who take part in the studies, the company said on Wednesday.
Pfizer, the largest U.S. pharmaceutical company, said it hoped the enhanced access to its data will help spur further scientific and medical research as well as encourage more patients to get involved in clinical trials.
By Bill Berkrot
(Reuters) – U.S. health officials are hopeful that hospitals and other healthcare providers will show sufficient preference for using drug compounders that sign up for regulatory scrutiny under a new law that potentially risky medicines will no longer be supplied by unregistered compounding pharmacies.
The law was spurred by the deadly outbreak of fungal meningitis last year that killed 64 Americans and sickened more than 700 due to contaminated injections made and shipped by a Massachusetts drug compounder that was not under the oversight of the Food and Drug Administration.
DALLAS (Reuters) – American cardiologists appear staunch in their support for President Barack Obama’s healthcare reform, although some fear that its rocky launch could derail efforts to improve preventive care for needy patients.
The broad support for the Affordable Care Act, popularly known as Obamacare, emerged in interviews last week in Dallas with more than 20 cardiologists at the annual scientific sessions of the American Heart Association. The group has set an aggressive goal of reducing heart disease and deaths from heart disease and strokes in the United States by 20 percent by 2020.
Nov 27 (Reuters) – Researchers have found a higher rate of
dangerous blood clots in patients who received Thoratec Corp’s
HeartMate II heart pump than had been seen in clinical trials or
prior experience, according to a study published on Wednesday.
They also found that when blood clots do develop, they are
occurring closer to the time of HeartMate implantation than had
been previously observed. The findings were reported in the New
England Journal of Medicine.
By Bill Berkrot
(Reuters) – Researchers have found a higher rate of dangerous blood clots forming in patients who received Thoratec Corp’s HeartMate II heart pump than had been seen in clinical trials or prior experience, according to a study published on Wednesday.
They also found that when blood clots do develop, they are occurring closer to the time of HeartMate implantation than had been previously observed. The findings were reported in the New England Journal of Medicine.
By Bill Berkrot and Ransdell Pierson
(Reuters) -Health regulators said on Monday they would lift restrictions on the use of GlaxoSmithKline Plc’s once widely prescribed diabetes drug Avandia, after determining that it did not increase the risk of heart attacks.
The U.S. Food and Drug Administration, following its review of a large clinical trial aimed at determining the drug’s heart safety called Record, said it found that the trial showed no elevated risk of heart attack or death in patients being treated with Avandia when compared with standard-of-care diabetes drugs.