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FDA approves new combination pill for HIV treatment for some patients

BY Allison Cerra

FOSTER CITY, Calif. — The Food and Drug Administration has approved a new once-a-day combination pill to treat HIV-1 infection in adults who have never been treated for HIV infection.

Gilead Sciences received regulatory for its treatment, Stribild (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate). Stribild contains two previously approved HIV drugs plus two new drugs, elvitegravir and cobicistat. Elvitegravir is an HIV integrase strand transfer inhibitor, a drug that interferes with one of the enzymes that HIV needs to multiply. Cobicistat, a pharmacokinetic enhancer, inhibits an enzyme that metabolizes certain HIV drugs and is used to prolong the effect of elvitegravir. The combination of emtricitabine and tenofovir disoproxil fumarate — approved in 2004 and marketed as Truvada — blocks the action of another enzyme that HIV needs to replicate in a person’s body. Together, these drugs provide a complete treatment regimen for HIV infection.

"Through continued research and drug development, treatment for those infected with HIV has evolved from multi-pill regimens to single-pill regimens," said Edward Cox, director of the Office of Antimicrobial Products in FDA’s Center for Drug Evaluation and Research. "New combination HIV drugs like Stribild help simplify treatment regimens."


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NCPA endorses Pennsylvania pharmacy audit reform bill

BY Allison Cerra

ALEXANDRIA, Va. — The National Community Pharmacists Association is encouraging Pennsylvania lawmakers to favorably move legislation (known as H.B.727) that is designed to "establish minimum and uniform standards and criteria for the audit of pharmacy records."

"This important legislation is based on a simple principle: When a pharmacist dispenses the right medication to the right patient at the right time, as prescribed by a doctor, it should not be a punishable offense," NCPA CEO Douglas Hoey said. "Pharmacists recognize the need for legitimate audits to protect public and private health plans from waste, fraud and abuse. However, pharmacy auditing practices are out of control. Time-consuming, abusive audits compromise pharmacists’ availability to counsel patients. Increasingly, they appear to be more about generating revenue for the middleman than rooting out fraud."

NCPA noted that more than 20 states have enacted similar bills into law and 10 of those states — Alabama, Indiana, Kentucky, Louisiana, Maryland, Minnesota, Mississippi, South Carolina, Utah and Vermont — have enacted or strengthened such laws in just the past five months. In California, such a measure recently passed both chambers of the state legislature.

Click here to read the letter.


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P&G donates $50K to support Paralympic athletic development

BY Antoinette Alexander

LONDON — As part of its support of the Paralympic Games, Procter & Gamble, a worldwide Olympic partner, has announced a grant of $50,000 to fund youth sports programs targeting children with physical disabilities.

The grant is part of the company’s donation to the United States Olympic Committee’s P&G|Team USA Youth Sports Fund, which provides broader access to youth sports programs in the United States.

P&G also is supporting moms of U.S. Paralympians through the “Thank you, Mom” gift of a $1,000 Visa reward card to help offset the travel costs of athletes’ families to the London 2012 Paralympic Games, as well as beauty services from P&G brands, including Pantene and CoverGirl for moms and families of U.S. Paralympians while in London.

The grant consists of support for both The United States Association of Blind Athletes and U.S. Club Sitting Volleyball. The USABA grant will go toward the organization’s “Sport 4 All” initiative, which provides recreational and competitive sport opportunities for youth who are blind and visually impaired. The Sitting Volleyball grant will be used to expand grassroots clinics and to support the first annual sitting volleyball summer camp for disabled youth.

P&G’s support for families of Paralympians in London, in addition to the grants and the gift, includes such salon services as haircuts, styling, makeup treatments and manicures provided by leading P&G brands, including Gillette, Pantene, CoverGirl and Clairol. Athletes will enjoy a similar salon in the Athlete Village, along with a dental clinic with services provided by Crest and Oral-B.

P&G also is activating its Paralympic Games partnership with a marketing campaign that includes real-time social media support and public relations efforts.

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