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Mondelez International reveals ‘Call for Well-Being’ strategy

BY Ryan Chavis

DEERFIELD, Ill. — Mondelez International, a snack industry leader whose portfolio includes such brands as Oreo and Nabisco, announced a plan to improve the well-being of our planet and people. The "Call for Well-Being" strategy seeks to broaden the reach and impact of the company’s programs. It will start with new global nutrition targets across its product mix, the company said.

"We know the health of people, communities, our business and the planet are inextricably linked," said Christine McGrath, VP external affairs and head of the company’s global well-being platform. "People around the world aspire to live healthier, better lives, but none of us can do it alone. We want to work with others to expand the conversation around well-being and bring an entrepreneurial approach to address the growing concerns around public health and the environment."

The "Call for Well-Being" focuses on four key areas:

Empowering consumers to snack mindfully. Mondelez International has set global nutrition targets to reach these goals by 2020: Grow "better choice" product to 25% of revenue, reduce sodium and saturated fat by 10%, increase whole grains by 25%, and increase individually wrapped options of 200 calories or less by 25%.

Partnering with communities. The company is investing $50 million in healthy-lifestyle community partnerships over the next several years, with a focus on nutrition education and the promotion of active lifestyles.

Securing sustainable agricultural supplies. The company will help farmers with a 10-year, $600 million investment in its Cocoa Life and Coffee Made Happy programs.

Reducing environmental footprint. The company will promote biodiversity and sound environmental practices. It also seeks to cut out energy and water use, waste and greenhouse gas emissions from manufacturing by 15% by 2015.

 

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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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