PHARMACY

The National Minority Quality Forum launches its CVD Atlas

BY Alaric DeArment

WASHINGTON An organization focused on health disparities among minority populations announced Monday that it would launch an atlas that maps the prevalence of cardiovascular disease nationwide.

The National Minority Quality Forum announced the launch of the CVD Atlas at its sixth annual Health Disparities Leadership Summit, with the endorsement of the American College of Cardiology and support from Novartis Pharmaceuticals Corp.

The atlas allows users to map the prevalence by state, legislative district, age, gender, race and ethnicity. Minority groups in the United States experience disparities in cardiovascular health that include higher rates of obesity, heart disease and other conditions, the NMQF said.

“More must be done to reduce the disparities in cardiovascular health seen across the country,” American College of Cardiology CEO Jack Lewin said. “The CVD Atlas represents a new tool in our efforts to reduce health disparities.”

The CVD Atlas is part of the NMQF’s ZIP code database, the Z Atlas, which also includes similar tools for HIV and AIDS, kidney disease and diabetes.

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New Democrat Coalition supports H.R. 1548

BY Alaric DeArment

WASHINGTON Leaders of the New Democrat Coalition voted Thursday to endorse a biosimilars bill introduced as an alternative to a bill that would use the Hatch-Waxman Act of 1984 as a model.

H.R. 1548, the Pathway for Biosimilars Act, introduced by fellow New Democrat Reps. Anna Eshoo of California and Jay Inslee of Washington, would allow a regulatory pathway for biosimilars but allow 14 years of market exclusivity, compared with the five-year period allowed by a bill introduced earlier by Rep. Henry Waxman, D-Calif.

“America’s patients want new cures, and they deserve access to cheaper medicines,” New Democrat chairwoman Rep. Ellen Tauscher of California said. “That’s why the Food and Drug Administration needs the authority to approve follow-on biologics.”

The bill, introduced on March 17, competes with Waxman’s Promoting Innovation and Access to Life-Saving Medicine Act, introduced on March 11, along with a companion bill introduced in the Senate on March 26. The Generic Pharmaceutical Association supports the Waxman bill, while the Biotechnology Industry Organization supports the Eshoo bill.

In other news, Sen. Orrin Hatch, R-Utah, who co-sponsored the Hatch-Waxman Act that made generic pharmaceutical drugs possible, broke with Waxman in telling reporters at drug regulation conference that he and Sen. Ted Kennedy, D-Mass., support longer exclusivity periods for biosimilars, according to published reports.

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FDA approves Johnson & Johnson’s Simponi to treat arthritis

BY Alaric DeArment

ROCKVILLE, Md. The Food and Drug Administration has approved a new drug for treating three types of arthritis.

The agency announced Friday that it had approved Johnson & Johnson’s Simponi (golimumab), a once-monthly injection for treating moderate-to-severe rheumatoid arthritis, active psoriatic arthritis and active ankylosing spondylitis, an arthritis of the spine.

“[Today’s] approval provides another treatment option for patients with these three debilitating disorders,” FDA Center for Drug Evaluation and Research Division of Anesthesia, Analgesia and Rheumatology Products director Bob Rappaport said. “And the steps we’re taking to minimize the risks will give patients the same level of safety protection required for other drugs in its class.”

Simponi, a monoclonal antibody made by J&J biologics division Centocor Ortho Biotech, is designed for use in combination with Barr Labs’ immunosuppressant drug Trexall (methotrexate) when treating rheumatoid arthritis, with or without Trexall when treating psoriatic arthritis and alone when treating ankylosing spondylitis.

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