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Merck submits FDA filing for ragweed allergy drug

BY Alaric DeArment

WHITEHOUSE STATION, N.J. — Drug maker Merck is seeking regulatory approval for an experimental tablet placed under the tongue that could be used to treat ragweed allergies.

Merck said the Food and Drug Administration accepted a regulatory application for its ragweed pollen sublingual allergy immunotherapy tablet. Ragweed, also known as Ambrosia artemisiifolia, is a major cause of seasonal allergies in the United States. Merck also submitted an application for a similar drug, for Timothy grass pollen allergies, in March.

The company expects the FDA to complete its review of both applications in the first half of next year. The drugs work by dissolving under the tongue and treating the underlying cause of allergic rhinitis by generating an immune response.

 

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Healthcare reform law provisions could affect pharmaceutical innovation, Bristol-Myers Squibb exec says

BY Alaric DeArment

WASHINGTON — Drug maker Bristol-Myers Squibb foresees significant effects on its business from the Patient Protection and Affordable Care Act, company executives told attendees of the its recent shareholder meeting.

In response to a question from a representative of conservative think tank the National Center for Public Policy Research, which is a shareholder in the company, about how the healthcare reform law’s Independent Payments Advisory Board and proposed mandatory drug rebate to the government for "dual eligibles" — patients eligible for Medicare and Medicaid — could affect drug innovation, Bristol U.S. pharmaceuticals division president Giovanni Caforio expressed concern about transparency and public access to medications.

Caforio said Bristol’s management would be "following very closely" developments regarding the board and the law in general, working with industry trade group the Pharmaceutical Research and Manufacturers of America to ensure transparent innovation, continued patient access and support for research and innovation.

 

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Independent pharmacists conduct more than 500 meetings with legislators on the Hill

BY Michael Johnsen

ALEXANDRIA, Va.  — More than 300 independent community pharmacists from across the country met in Washington, D.C., at the Hyatt Regency on Capitol Hill Wednesday for the 2013 National Community Pharmacists Association Conference on Legislation and Government Affairs. The pharmacists conducted more than 500 meetings with congressional offices.

“Independent community pharmacists play a critical role in improving patient outcomes and reducing costs,” stated Douglas Hoey, NCPA CEO. “However, those efforts can be undermined by the decisions made in Washington and in state capitals across the country. NCPA’s Legislative Conference is the perfect venue to give independent community pharmacists the megaphone they need to tell Congress why pro-pharmacist legislation is pro-patient and ultimately the right thing to do for the constituents they represent," he said. "This year the megaphone grew louder, because independent community pharmacists also advocated for change from outside the confines of Washington over a more extended period of time.”

Rep. Tom Marino, R-Pa., kicked off the conference by addressing the members at the opening luncheon. Rep. Cathy McMorris Rodgers, R-Wash., House Republican Conference Chairman, addressed the membership at the general session. Panels discussed the implementation of the Affordable Care Act as well as insiders’ perspective from congressional staff on general health care and pharmacy issues.

“Based on the feedback we have received from attendees, this year’s Legislative Conference and accompanying Community Pharmacy Advocacy Weeks have been a huge success,” Hoey said. “The 113th U.S. Congress is only a few months old, so now is the time to educate elected officials about the problems we face and propose remedies to fix them. The response to those efforts was very positive.”

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