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Dec 18, 2013

Stellar hepatitis C data puts Gilead farther ahead of pack

By Ransdell Pierson and Bill Berkrot

(Reuters) – Gilead Sciences Inc released impressive late-stage data for its once-daily combination pill to treat hepatitis C, advancing its lead in the race to develop new, all-oral treatments for the liver disease, and pushed up its timeline for seeking U.S. approval.

Gilead on Wednesday unveiled initial results from three Phase III studies that demonstrated cure rates well in excess of 90 percent with as little as 8 weeks of treatment for some patients.

Dec 13, 2013

AbbVie drug shows promise against difficult type of breast cancer

By Bill Berkrot

(Reuters) – Women with an especially deadly type of breast cancer who received a treatment regimen containing an experimental AbbVie Inc drug prior to surgery are likely to have a significantly better response than those who get a standard chemotherapy regimen, according to data from a clinical trial.

Patients with so-called triple negative breast cancer, who tend to be younger and have a very poor prognosis, appeared to have double the response rate to the regimen containing AbbVie’s veliparib in a new type of study that exploits advances in molecular understanding of the disease, researchers found.

Dec 10, 2013

CVS, Cardinal Health form U.S. generic drug venture

By Bill Berkrot

(Reuters) – Pharmacy chain CVS Caremark Corp and pharmaceutical distributor Cardinal Health Inc on Tuesday announced a 10-year agreement to form the largest generic drug sourcing operation in the United States, the world’s biggest generic drug market.

The 50-50 joint venture, which combines the generic drug purchasing power of two of the largest companies in the market for the cheaper medicines, will be operational as soon as July 1, 2014. Under the agreement, Cardinal will pay CVS $25 million on a quarterly basis for the duration of the contract, with an estimated after-tax value to CVS of $435 million.

Dec 10, 2013

AbbVie oral hep C drugs cure 96 pct in late stage trial

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, 2013

U.S. FDA advisory panel backs Takeda bowel disease drug

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, 2013

High response rates seen with oral Takeda myeloma drug -study

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.

Dec 8, 2013

J&J, Pharmacyclics leukemia drug effective long term: study

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.

Dec 4, 2013

Pfizer to expand clinical data access to researchers, patients

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.

Dec 2, 2013

FDA to promote use of registered drug compounders under new law

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.

Nov 28, 2013

Cardiologists strongly back Obamacare, worry over rocky start

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.

    • 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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