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FDA grants orphan drug status to Eisai’s investigational compound for cutaneous T-cell lymphoma

BY Jason Owen

WOODCLIFF LAKE, N.J. — Eisai Inc., announced today that the U.S. Food and Drug Administration has granted orphan drug designation to its investigational compound (E7777) for cutaneous T-cell lymphoma. E7777 is designed to have an improved purity profile and manufacturing process. It is currently in a pivotal trial intended to support its submission for approval.

The Orphan Drug Act allows FDA to grant orphan status to a drug which has the potential for the treatment, diagnosis, or prevention of a rare disease/disorder that affects fewer than 200,000 people in the United States.

CTCL is a rare type of cancer that begins in the white blood cells and attacks the skin. It is one of several types of lymphoma collectively called non-Hodgkin lymphoma.


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New Hydratherma Naturals Healthy Hair Care line aims to balance moisture, protein in hair

BY Antoinette Alexander

ATLANTA — Healthy Hair Journey Enterprises has introduced the Hydratherma Naturals Healthy Hair Care Collection, a line of natural-based products developed to improve, enhance and maintain healthy hair.

According to the company, it is possible for hair to be over-moisturized, generating protein deficient hair that is weak and limp and unable to hold a curl. On the other hand, hair that has too much protein and is moisture deficient will appear dry and brittle and break easily. The combination of protein and moisture and the synergy of these two agents is the key to healthy hair and natural hair growth and the secret behind how Hydratherma Naturals products deliver on its promise of length retention and beautiful, frizz-free natural curls.

Saleemah Cartwright, a registered nurse and licensed cosmetologist by trade, noticed while working on her clients’ hair that when the hair was well-balanced, the hair would flourish. Too much moisture or protein would result in breakage. Many of her clients, however, did not know how to achieve this balance.

"I tried many products on my hair and the hair of my clients. Most products would result in too much moisture or protein overload in the hair. So after several years of combining many of the hair care ingredients that I absolutely loved, I was able to design a natural-based hair care collection that provides the perfect balance of moisture and protein levels. I wanted to create an effective solution and a simple hair care regimen that my clients could easily follow," stated Cartwright, creator of Hydratherma Naturals and co-founder of Healthy Hair Journey Enterprises.

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Keryx Biopharmaceuticals announces NDA for hyperphosphatemia treatment in chronic kidney disease patients

BY Jason Owen

NEW YORK — Keryx Biopharmaceuticals, Inc., today announced the submission of a new drug application to the U.S. Food and Drug Administration seeking approval for the marketing and sale of Zerenex (ferric citrate coordination complex), the company’s drug candidate for the treatment of elevated serum phosphorus levels, or hyperphosphatemia, in patients with chronic kidney disease on dialysis. The company’s NDA submission is based primarily on the data sets derived from its Phase 3 registration program, which was conducted pursuant to a Special Protocol Assessment agreement with the FDA, and is also supported by efficacy and safety data from several additional studies, including four Phase 3 studies conducted in Japan in CKD patients on dialysis.

"The submission of the Zerenex NDA marks a major milestone for the Company. With approximately 1,500 patients exposed to the drug in the clinical development programs conducted by us and our Japanese partner, JT/Torii, we believe that Zerenex is a safe, effective and highly-differentiated drug candidate and today’s submission brings us one step closer to potentially bringing this drug to patients who can benefit from it," said Ron Bentsue the company’s CEO. "We are grateful to Dr. Julia Lewis, the Study Chair for the Zerenex Phase 3 program, and to our highly skilled internal team of clinical, manufacturing and regulatory professionals, for the time and effort they have dedicated towards this tremendous achievement," continued Bentsur.

The company also plans to submit a Marketing Authorization Application to the European Medicines Agency for regulatory approval of Zerenex in the European Union.

Keryx holds a worldwide license (except for certain Asian Pacific countries) to Zerenex from Panion & BF Biotech, Inc. The Japanese rights are sublicensed by Keryx to Japan Tobacco Inc. and Torii Pharmaceutical Co., Ltd. On January 7, 2013, JT announced the filing of its NDA with the Japanese Ministry of Health, Labour and Welfare for marketing approval of ferric citrate in Japan for the treatment of hyperphosphatemia in patients with CKD.

Zerenex is also in Phase 2 development in the U.S. for the management of phosphorus and iron deficiency in anemic patients with Stage 3 to 5 non-dialysis dependent CKD.

 

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