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FDA grants orphan drug designation to 4SC cancer treatment

BY Alaric DeArment

PLANEGG-MARTINSRIED, Germany — The Food and Drug Administration has granted orphan drug designation to a cancer treatment in mid-stage development made by German drug maker 4SC, the company said Tuesday.

4SC announced that it received the designation for resminostat, currently in phase-2 clinical trials as a treatment for hepatocellular cancer, or HCC. The FDA grants orphan drug designation to drugs for diseases that affect fewer than 200,000 people in the United States.

HCC is a liver cancer resulting from hepatitis infection and liver cirrhosis due to alcoholism. Despite its relative rarity in North America and Europe, it is the world’s sixth most common cancer and the third-leading cause of cancer-related death, with a particularly high prevalence in Southeast Asia due to high rates of hepatitis B infections in the region.

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New service helps retailers find ways to donate overstocked merchandise

BY Michael Johnsen

NASHVILLE, Tenn. — The Retail Orphan Initiative on Tuesday announced the launch of an online charity locator to match up retailers looking to donate overstocked merchandise with local charities.

The charity locator features an interactive map of nearby charities from a RetailROI-developed database of 501c3 organizations across the country that focus on at-risk children, women in distress or families in need. The charity locator includes the top 125 cities and top 300 largest malls in the United States, with information on the types of items accepted by each charity, including clothing, food, furniture, building materials and educational materials. 

Of an estimated $65 billion in overstocks, the vast majority is housed in small lots at local stores, which makes it costly to consolidate the merchandise, RetailROI stated. 

“Retailers’ overstocks can make a huge difference,” stated Greg Buzek, president of IHL Group and donor trustee for the Retail Orphan Initiative. “By cleaning their stores of the items that aren’t selling and getting their employees focused on the items that are, they help women and children in need — providing a lifeline that brings long-term dividends to the community. ” 

RetailROI’s charity locator is available online at RetailROI.org/charity-locator

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HHS offers framework to establish Affordable Insurance Exchanges

BY Michael Johnsen

WASHINGTON — The U.S. Department of Health and Human Services on Monday proposed a framework to assist states in building Affordable Insurance Exchanges, state-based competitive marketplaces where individuals and small businesses will be able to purchase affordable private health insurance.

“Exchanges offer Americans competition, choice and clout,” stated HHS Secretary Kathleen Sebelius. “Insurance companies will compete for business on a transparent, level playing field, driving down costs; and Exchanges will give individuals and small businesses the same purchasing power as big businesses and a choice of plans to fit their needs.”

The National Community Pharmacists Association issued a statement of initial support of the HHS document, specifically citing the need to create a transparent, level playing field with regard to pharmacy benefit managers. “Community pharmacists applaud the department for including in the proposed rule PBM transparency language, a bipartisan provision of the [Patient Protection and] Affordable Care Act,” stated NCPA EVP and CEO Douglas Hoey. “With this step, the administration is also reaffirming its support for PBM transparency in the exchanges by including an implementation pathway in the rule.”

Beginning in 2014, Exchanges will make it easy for individuals and small businesses to compare health plans, find out if they are eligible for tax credits for private insurance or health programs like the Children’s Health Insurance Program, and enroll in a health plan that meets their needs, according to HHS.

HHS is accepting public comment on the proposed rules over the next 75 days to learn from states, consumers and other stakeholders how the rules can be improved. HHS will modify these proposals based on feedback from the American people. To facilitate that public comment process, HHS will convene a series of regional listening sessions and meetings.

For more information on Exchanges, including fact sheets, visit Healthcare.gov/exchanges.
 

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