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Cellceutix gets FDA nod to accelerate development of psoriasis treatment

BY Michael Johnsen

BEVERLY, Mass. — Cellceutix on Wednesday reported that the Food and Drug Administration granted a section 505(b) designation for its Prurisol treatment for psoriasis, which would allow the company to forgo early-stage trials and advance Prurisol into latter-stage clinical trials.

"It was a very productive meeting with the FDA, providing us with valuable advice about advancing Prurisol down the regulatory pathway," stated Cellceutix CEO Leo Ehrlich. "Now we will begin the preparatory work necessary for a phase-2 clinical trial application for Prurisol based upon the FDA guidance," he said.

"The recent activity of Steifel Labs, a GlaxoSmithKline company, spending approximately $350 million to acquire rights to skin treatment drugs still in development from Welichem Biotech and Basilea Pharmaceutica demonstrates how valuable and in high demand new dermatological drugs are right now," Ehrlich added. "This is a very exciting time for Cellceutix and its shareholders as we transition from pre-clinical to clinical with drugs that have incredible potential."

Cellceutix previously has disclosed images of mice treated with Prurisol demonstrating its effectiveness as compared with methotrexate, a standard care treatment for psoriasis today.

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NACDS urges expansion of PDUFA provisions to ensure patient care, curb Rx abuse

BY Antoinette Alexander

ALEXANDRIA, Va. — As the U.S. Senate and House reconcile their versions of the Prescription Drug User Fee Act, the National Association of Chain Drug Stores on Wednesday urged U.S. House and Senate leaders to expand provisions in the final bill to help ensure that Americans continue to have access to safe and effective prescription medications, while also curbing prescription drug abuse.

In letters to Senate Health, Education, Labor and Pensions Committee chairman Tom Harkin, D-Iowa, and ranking member Michael Enzi, R-Wyo. — and to House of Representatives Energy and Commerce Committee chairman Fred Upton, R-Mich., and ranking member Henry Waxman, D-Calif. — NACDS expressed concerns that current PDUFA language does not go far enough to ensure access to prescription medications for patients who need them for pain management and for the success of their treatment plans.
 
Language in the current PDUFA bills requires the Food and Drug Administration to review current federal initiatives combating prescription drug abuse to identify gaps and opportunities, and issue a report of the findings.  
 
“We believe that to address the problem of prescription drug abuse, rather than just having the FDA issue a report, the FDA and DEA must work collaboratively on an ongoing basis. We believe that requiring these agencies to work together would result in better policy solutions, and would greatly help to ensure that legitimate patient access to controlled substance medications is not jeopardized by DEA actions as it is today,” NACDS stated in the letters.
 
NACDS also urged congressional leaders to amend a provision in the U.S. Senate’s version of PDUFA that would require the U.S. Department of Health and Human Services to contract with the Institute of Medicine on a study of drug abuse to evaluate trends, assess opportunities to inform and educate the public, patients and healthcare providers.
 
In the letters, NACDS recommended that this provision be enhanced beyond these assessments and include work with stakeholders to recommend solutions to the problems of drug diversion and abuse.
 
“The HHS-IOM process should include a mechanism for panel discussions to include DEA, FDA, patient groups, pharmacy groups, prescriber groups, wholesaler groups, state attorneys general and law enforcement representatives. Only by inclusion of these key stakeholders can we be assured that the IOM study would provide actionable recommendations that will have a meaningful impact on drug diversion and abuse,” NACDS stated in its letters.
 
“Prescription drug abuse is a complex and immediate problem. To address this problem while ensuring legitimate patient access to prescription medication, I ask for your support in expanding PDUFA legislation so that the FDA and DEA will work together, as well as expanding the HHS-IOM process,” NACDS concluded in the letters.
 
NACDS emphasizes that chain pharmacies have zero tolerance for prescription drug diversion, and are committed to helping patients ensure access to their needed prescription medications. Beyond the concepts advanced in its letters to Congress, NACDS members have developed policies and procedures to comply with the DEA regulatory regime and similar requirements from state agencies, such as boards of pharmacy and narcotic drug agencies. NACDS members also have implemented a variety of loss prevention and internal security systems.

Further, NACDS supports the Online Pharmacy Safety Act, which would help to shut down illegitimate Internet drug sellers, sponsored by U.S. senators Dianne Feinstein, D-Calif., and Jeff Sessions, R-Ala., and in the House by Reps. Bill Cassidy, R-La., and Mike Ross, D-Ark.

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Walgreens biggest winner for exclusive Biggest Loser brand at LIMA award show

BY Michael Johnsen

LAS VEGAS — Walgreens was the biggest winner for its exclusive line of Biggest Loser weight-loss products here during the LIMA Opening Night Awards Ceremony here Tuesday.

Walgreens was named Best Retailer of the Year by the Licensing Industry Merchandiser’s Association for its Biggest Loser line of meal replacement bars and shakes licensed through NBCUniversal Television Consumer Products in May 2011.

The shakes and meal bars were developed with the guidance and oversight of “The Biggest Loser’s” nutrition expert, Michael Dansinger, and contain 10 g of protein per item.

The shakes, available in milk chocolate and creamy vanilla flavors, were supplemented with several vitamins and minerals but low in sodium. The meal bars come in four flavors — banana nut bread, chocolatey coconut, cinnamon apple turnover and peanut butter chocolate chip — and contain a half serving of fruit.

"The Biggest Loser" products first were unveiled on April 6 in New York City at a launch event for the Walk with Walgreens program. The event was hosted in part by "The Biggest Loser" host Alison Sweeney, who is a national spokeswoman for Walk with Walgreens.

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