XOMA Corp (XOMA) FDA Orphan Drug Designation for a Rare Neutrophilic
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XOMA Corporation (XOMA)
The neutrophilic dermatoses are a group of disorders characterized by skin lesions for which histologic examination reveals intense epidermal and/or dermal inflammatory infiltrates composed primarily of neutrophils with no evidence of infection.
Pyoderma gangrenosum (PG), a rare neutrophilic dermatosis, is an inflammatory skin disorder that is characterized by small, red bumps or blisters (papules or nodules) that eventually erode to form swollen open sores (ulcerations).
Classic PG can occur on any skin surface, but is most commonly seen on the legs. Patients are often systemically unwell with symptoms such as fever, malaise, arthralgia, and myalgia. Lesions are usually painful and the pain can be severe. When the lesions heal the scars are often cribriform.
PG may occur at any age, but the peak incidence is age 20-50, with female preponderance. The U.S. Department of Health and Human Services' National Institutes of Health's Office of Rare Disease Research lists PG occurring in about 1 per 100,000 people.
XOMA reported that its gevokizumab has been granted Orphan Drug Designation by the U.S. FDA for the treatment of pyoderma gangrenosum (PG).
Orphan drug designation is granted by the FDA Office of Orphan Products Development to novel drugs or biologics that treat a rare disease or condition affecting fewer than 200,000 patients in the U.S.
The designation provides the drug developer with a seven-year period of U.S. marketing exclusivity, as well as tax credits for clinical research costs, the ability to apply for annual grant funding, clinical research trial design assistance and waiver of Prescription Drug User Fee Act filing fees.
XOMA 's gevokizumab is a potent monoclonal antibody with unique allosteric modulating properties and the potential to treat patients with a wide variety of inflammatory and other diseases. XOMA has a Proof-of-Concept program underway in which the Company is exploring the efficacy and safety of gevokizumab in multiple indications.
XOMA has built a portfolio of innovative therapeutic antibodies, both in late-stage clinical development and in preclinical research. XOMA focuses its antibody research and development on allosteric modulation, which offers opportunities for new classes of therapeutic antibodies to treat a wide range of human diseases.
More about XOMA Corporation (XOMA) at www.xoma.com .
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Crown Equity Holdings Inc. (CRWE)
A social networking service is an online service, platform, or site that focuses on facilitating the building of social networks or social relations among people who, for example, share interests, activities, backgrounds, or real-life connections.
CRWE is currently developing its CRWE Network ( CRWE-PR.com ), a social networking service compatible with both, the mobile and desktop web platform, that is designed to target all the communities in the U.S. and Canada, which business model is based on selling advertising to local businesses.
The CRWE Network has included in its platform a coupon page, giving business owners some flexibility in instantly creating, modifying and publishing promotional deals to consumers of every kind, such as local restaurants, auto repairs, realtors, bars, movie theaters, retailers, golf courses, auto dealerships and any other variety of businesses existing within a community.
CRWE presently has more than 70 U.S. cities and 9 cities from Canada in its network of community publications.
CRWE Network’s goal is to facilitate exchanges of goods and services in a manner similar to Craigslist, a classified advertisements website with sections devoted to jobs, housing, personals, for sale, items wanted, services, community, gigs, résumés, and discussion forums, while providing micro community news, information and business directory content.
CRWE provides marketing solutions that boost customer awareness and merchant visibility on the Internet
More about Crown Equity Holdings Inc. (CRWE) at www.crownequityholdings.com
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zulily, Inc. (ZU)
Keep a close eye on ZU . The company reported strong performance on its financial results.
For the fourth quarter 2013, ZU posted net sales of $257.0 million, a 100% increase year over year, adjusted EBITDA of $17.8 million, a 277% increase compared to the same period the prior year, and net income of $12.8 million, a 293% increase compared with the fourth quarter 2012.
For the full year 2013, ZU 's net income increased to $12.9 million compared to a net loss of $(10.3) million in the prior year.
ZU offers daily deals for moms, babies and kids. ZU sales launch daily, filled with quality children's apparel, women's apparel, toys, infant gear and home decor at a discount. Unique finds from up-and-coming brands are featured alongside selections from top brands, giving every mom something new to discover every day.
More about zulily, Inc. (ZU) at www.zulily.com
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