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Dec 6, 2014

Addition of Amgen drug boosts benefits in relapsed myeloma -study

Dec 6 (Reuters) – Significantly more patients with relapsed
multiple myeloma responded to a three-drug regimen including
Amgen Inc’s Kyprolis than those who got the standard
two-drug treatment, according to results from a late-stage
trial.

Patients with the blood cancer who received the Kyprolis
regimen for 18 months also had a longer duration of response and
reported better health-related quality of life, data presented
on Saturday showed.

Dec 3, 2014

U.S. FDA approves Amgen leukemia drug ahead of schedule

By Bill Berkrot

(Reuters) – U.S. health regulators on Wednesday approved an Amgen Inc drug that helps the immune system fight a rare type of leukemia, more than five months ahead of the expected decision date.

The drug, blinatumomab, which will be sold under the brand name Blincyto, was approved to treat a form of acute lymphoblastic leukemia (ALL) for which there are few treatment options once a patient has relapsed.

Nov 24, 2014

Roche’s Genentech defends supply shift for top cancer drugs

Nov 24 (Reuters) – Genentech, U.S. biotech unit of Roche
Holding, faces growing pressure over a decision to
allow only a handful of distributors to supply three of the
world’s most widely used cancer drugs, a move that prominent
hospitals say will create delays and raise costs.

Genentech in October began distributing Avastin, Herceptin
and Rituxan to hospitals and clinics through six specialty drug
distributors, rather than through drug wholesalers, which
distribute a wide range of medicines, devices and equipment on
an enormous scale. Specialty distributors supply biologic
infusion medicines that often require special storage and
handling.

Nov 21, 2014

New data fuels doctors’ demands to rewrite U.S. heart guidelines

CHICAGO, Nov 21 (Reuters) – Controversial heart disease
prevention guidelines that abandoned specific targets for
reducing “bad” LDL cholesterol are under fresh assault after a
major study highlighted the benefits of taking LDL to very low
levels.

Guidelines issued last year by the American Heart
Association and the American College of Cardiology asked doctors
to assess individual patients’ risk for heart disease over 10
years based on a complex calculation of risks posed by
lifestyle, family history and other health conditions. Those
deemed at sufficient risk would be prescribed
cholesterol-lowering statins.

Nov 19, 2014

Boston Scientific stent succeeds in study aimed at U.S. approval

CHICAGO, Nov 19 (Reuters) – Boston Scientific Corp’s
next generation Synergy heart stent succeeded in a pivotal study
that will be used to seek U.S. and Japanese approval of the
device, according to data presented at the American Heart
Association meeting in Chicago on Wednesday.

The ultra thin Synergy drug eluting stent, featuring a
bioabsorbable polymer coating that dissolves once the drug has
been fully delivered after about three months, proved comparable
to the company’s widely used Promus Element Plus stent in key
measures, achieving the main goal of the non-inferiority trial.

Nov 17, 2014

Novartis heart failure drug provides host of benefits: study

CHICAGO (Reuters) – An experimental heart failure medicine from Novartis that previously showed it reduced death and hospitalizations also curtailed worsening of symptoms, need for additional therapy and emergency room visits, adding to evidence that it will become the drug of choice once approved.

A lengthy list of additional benefits including significantly fewer intensive care unit stays from treatment with the drug, LCZ696, in the Paradigm-HF study of 8,442 patients called were presented at the American Heart Association meeting in Chicago on Monday.

Nov 17, 2014

Regeneron drug highly effective for those who can’t take statins -study

CHICAGO, Nov 17 (Reuters) – Regeneron Corp’s
experimental drug alirocumab helped 10 times as many high-risk
patients unable to tolerate widely-used statins get their “bad”
LDL cholesterol down to target levels than Merck & Co’s
Zetia, according to data from a clinical trial presented on
Monday.

Alirocumab, developed along with French drugmaker Sanofi
, belongs to a new class of potent drugs that block a
naturally occurring protein called PCSK9 that prevents the liver
from removing LDL from the blood.

Nov 17, 2014

Merck’s Zetia cuts heart attack, stroke risk in long-awaited study

CHICAGO (Reuters) – After years of uncertainty, a nearly decade-long study showed that Merck & Co’s cholesterol drug Zetia significantly lowered the risk of heart attacks and strokes in high-risk heart patients when used with a highly effective statin.

The data, released Monday, proves that Zetia – widely used for a dozen years due to its ability to lower “bad” LDL cholesterol levels – provides important protection to some patients, and supports a theory that bringing LDL down to very low levels adds further benefit.

Nov 16, 2014

Extended anti-clotting therapy cut heart attacks after stent -study

CHICAGO, Nov 16 (Reuters) – Patients who took two
anti-clotting drugs for 30 months after undergoing a heart stent
placement significantly cut their risk of heart attacks and
blood clots in the stent compared with patients receiving the
dual therapy for the standard 12 months, a clinical trial
showed.

In this five-year study of nearly 10,000 patients who had
received drug-coated stents in an artery clearing procedure, the
rate of heart attacks was 2.1 percent for those who received
dual anti-clotting therapy for 30 months. The rate was 4.1
percent for those who got aspirin and a placebo after 12 months
of dual therapy, researchers reported.

Nov 12, 2014

Future of Merck cholesterol sales could hang on long-awaited study

By Bill Berkrot and Ransdell Pierson

(Reuters) – A nine-year, 18,000-patient study of Merck & Co’s $4 billion Zetia and Vytorin cholesterol franchise is likely to show some benefit but keep open the question of whether it can significantly reduce heart attacks, strokes and death.

The Improve-It trial is aimed at determining whether Zetia – which is also combined with Merck’s now generic statin Zocor (simvastatin) to make Vytorin – does more than reduce “bad” LDL cholesterol in the bloodstream, the basis for which it was approved.

    • 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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