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FDA approves Upsher-Smith’s Qudexy XR extended-release capsules

BY Antoinette Alexander

MAPLE GROVE, Minn. — Upsher-Smith has received approval from the Food and Drug Administration for Qudexy XR (topiramate) extended-release capsules, a once-daily, broad-spectrum antiepileptic drug specifically engineered to deliver a smooth pharmacokinetic profile.

Qudexy XR will be available to patients in second quarter 2014.

Qudexy XR is indicated as initial monotherapy in patients 10 years of age and older with partial-onset seizures or primary generalized tonic-clonic seizures. It also is approved as adjunctive therapy in patients 2 years of age and older with POS, primary generalized tonic-clonic seizures and seizures associated with Lennox-Gastaut syndrome.   

"Upsher-Smith is pleased by the FDA’s approval of Qudexy XR," stated Mark Evenstad, president and CEO of Upsher-Smith. "Today’s approval is a major milestone in Upsher-Smith’s history, as Qudexy XR is the first branded product in our central nervous system portfolio. At Upsher-Smith, our mission is to make a measurable improvement in people’s lives by focusing on the patient."

Qudexy XR is available in 25-mg, 50-mg, 100-mg, 150-mg, and 200-mg extended-release capsules.

 

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National campaign launched to help boost diversity in clinical trials

BY Antoinette Alexander

WASHINGTON — The Pharmaceutical Research and Manufacturers of America and the National Minority Quality Forum announced on Wednesday a first-of-its-kind national campaign to help increase diversity in clinical trials.

The “I’m In” campaign will aim to raise awareness about the importance of clinical research and encourage greater participation by diverse patient populations to help researchers develop potential new life-saving medicines. Partnerships with patient advocacy organizations, provider groups, individual physicians, clinical trials sponsors and researchers will help to drive campaign awareness and involvement.

"PhRMA and our member companies are committed to raising awareness and increasing participation in clinical trials, particularly among historically underrepresented populations," stated John Castellani, president and CEO of PhRMA. "Through this collaboration of healthcare leaders, we are taking a major step forward to help reduce health disparities through greater inclusiveness in clinical research."

Developing new medicines is a lengthy and complex process, relying heavily on volunteer participation to evaluate potential therapies for safety and effectiveness in clinical studies. Without the patients who volunteer to participate in clinical trials, the development of new medicines would not be possible.

However, such groups as African-Americans, Asian-Americans and Hispanics are significantly underrepresented in clinical research. According to the Food & Drug Administration, African-Americans represent 12% of the U.S. population, but only 5% of clinical trial participants; Hispanics make up 16% of the population, but only 1% of clinical trial participants. Inclusion of individuals of varied races, ethnicities, ages, gender and sexual orientation in clinical trials can help to prevent disparities in the evaluation of potential new medicines.

"According to the FDA, increased diversity in clinical trials could help researchers find better ways to fight diseases that disproportionately impact certain populations, and may be important for the safe and effective use of new therapies," stated Gary Puckrein, president and CEO of the National Minority Quality Forum. "Through the ‘I’m In’ campaign, new online resources, such as the Clinical Trial Engagement Network, will be introduced to empower individuals to learn more about clinical trials and the benefits of participating in clinical research."

“I’m In” will support the build-up of the National Minority Quality Forum’s Clinical Trial Engagement Network, a solution to help accelerate the inclusion of underrepresented populations in clinical trials. Authorized users will be able to identify potential clinical trial participants by utilizing ZIP code level mapping of disease clusters, and simultaneously identifying and connecting points of care and community resources that can assist with site selection and patient recruitment.

 

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NRF pushes for online sales tax

BY Dan Berthiaume

WASHINGTON — The National Retail Federation is urging Congress to pass legislation that would require online and remote sellers to collect state and local sales taxes, telling a House committee that lawmakers should level the playing field between local retailers and out-of-state competitors. David French, SVP of the NRF, told the House Judiciary Committee in a letter that legislation is needed to end the sales tax disparity.

While brick-and-mortar merchants are required to collect state and local sales taxes on most items, many out-of-state sellers are not required to do so, giving them what the NRF says is an unfair price and market advantage of as much as 10%. The committee is scheduled to hold a hearing on the issue Wednesday, March 12.

NRF urged the committee to consider online sales tax legislation, based on principles outlined last fall by Chairman Bob Goodlatte, R-Va., that recognizes compliance costs, eliminates the current patchwork of state laws and court decisions, and simplifies the collection process. Under the U.S. Supreme Court’s 1992 Quill ruling, online retailers are required to collect sales tax only in states where they have a physical presence, such as a headquarters, store, office or warehouse. Federal legislation passed in the Senate last year would provide states the ability to require sales tax collection.

“Members of the National Retail Federation believe that Congress must resolve the constitutional questions posed by the Quill decision in a fashion that promotes a level playing field between retail competitors,” French said. “As retailing evolves and Internet sales become a more prominent portion of total retail sales, it is critical that Congress address the sales tax collection discrimination that exists between brick-and-mortar and remote retailers.”

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