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Merck drug for HIV effective, tolerated, study results show

BY Alaric DeArment

CHICAGO — A drug made by Merck for treating HIV infection was effective and tolerated in patients regardless of their gender or race, according to results of a late-stage clinical trial announced Monday.

Merck announced the release of data from the phase-3 "REALMRK" study showing that Isentress (raltegravir) combined with other drugs produced results similar to those seen in other phase-3 studies. The REALMRK study enrolled 209 patients who had not previously received treatment for HIV, as well as those for whom previous treatments didn’t work. Of the patients enrolled, 74.6% were black, while 46.9% were women.

"Results from the REALMRK study demonstrate the benefits of Isentress in combination therapy in a diverse patient population that refelcts the faces of money people living with HIV-1 today," director of the division of infectious disease and environmental medicine at Thomas Jefferson University’s medical school and lead study investigator Kathleen Squires said. "Blacks and women are disproportionately affected by the HIV epidemic."

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FDA approves two new indications for Amgen’s Prolia

BY Alaric DeArment

THOUSAND OAKS, Calif. — The Food and Drug Administration has approved two new uses for a drug made by Amgen, the drug maker said Monday.

Amgen announced the approval of the biotech drug Prolia (denosumab) for increasing bone mass in men and women who are at risk of fractures due to hormone ablation treatments they are receiving for prostate and breast cancer, respectively.

"Bone loss and fractures are recognized adverse effects of hormone ablation therapies, but we have not had an approved treatment option to prevent these problems for our patients," Massachusetts General Hospital Cancer Center genitourinary malignancies program head Matthew Smith said. "Prolia now gives us the ability to reduce the risk of bone loss and fractures, allowing patients to continue their treatment and their fight against cancer."

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NACDS warns of Express Scripts-Medco deal in radio ad

BY Allison Cerra

ALEXANDRIA, Va. — The National Association of Chain Drug Stores has launched a new drive-time radio advertisement in the Washington, D.C., market to warn of the potential consequences of the proposed merger between pharmacy benefit managers Express Scripts and Medco.

(Listen to the radio ad here)

The ad, which was launched in line with a hearing that will take place in Congress this week pertaining to the deal, further warns of the deal’s "feared anticompetitive and anticonsumer consequences," NACDS said. The ad also discusses “an unknown middleman controlling the majority of private pharmacy benefits” and the merged entity’s “unprecedented power over drug supplies, drug prices and access to … medicine,” the pharmacy group added.

“NACDS has utilized advertising as part of a comprehensive effort to tell the true story of pharmacies as the face of neighborhood health care and the unparalleled value of pharmacies in improving patient health and reducing costs,” NACDS president and CEO Steve Anderson said. “NACDS is committed to utilizing the modern tools of advocacy to present innovative solutions for advancing cost-effective and high-quality patient care, as well as to vigorously confront serious threats that jeopardize these vital principles."

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