Following a review of topical formulations of ketoprofen, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefit-risk balance of these medicines continues to be positive. However, the Committee recommended that doctors should inform patients on how to use these medicines appropriately. Ketoprofen is a non-steroidal anti-inflammatory drug (NSAID). Topical formulations of ketoprofen are used to treat minor trauma, tendonitis, small-joint osteoarthritis, acute low-back pain and phlebitis.

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AmStem Corporation announced positive early results from its preliminary consumer study of SteMixx™. Full study results will be available at the end of this month. AmStem has engaged a labeling consultant for their flagship SteMixx™ product to make it available for retail consumer use as soon as possible in the U.S. AmStem has finalized its submission to an independent Institutional Review Board (IRB) to begin the first clinical trial of SteMixx in the United States.

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Nitric BioTherapeutics, Inc. announced the initiation of a Phase II clinical trial of the company’s proprietary drug/device combination, which delivers terbinafine via the process of iontophoresis for the treatment of onychomycosis. Onychomycosis is commonly known as toenail fungus. Nitric Bio’s proprietary drug/device combination delivers very high doses of a unique formulation of terbinafine, the most effective medication used to treat onychomycosis, directly to the site of the infection – on, around and under the toenail.

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Dermal fillers are often confused with Botox, and though both are delivered by injection, they serve very different purposes. As the name implies, fillers are designed to plump wrinkles, fill in hollowness and enhance lips, while Botox targets and relaxes muscles to prevent new lines from developing. The advantages of fillers outweigh the risks, according to experts such as Dr. Neal Schultz of DermTV.com. Fillers are generally cost-effective (starting at a few hundred dollars), easy to administer and natural looking. Schultz says. The effects generally last four to 12 months. The risks? Fillers can cause occasional bruising, mild pain or discomfort when injected and, in rare circumstances, allergic reactions.

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E. Fougera & Co has received first generic approval from the FDA for Adapalene Cream 0.1% (Rx) for the treatment of acne vulgaris. Fougera’s Adapalene Cream 0.1% is rated AB, generically equivalent to Differin® by Galderma Pharmaceuticals. According to industry data, U.S. sales of the brand named product in 2009 exceeded $55 million. This approval also marks the fourth product approval that the FDA has granted to Fougera this year.

Mesynthes has introduced a tissue substitute for people suffering from tissue damage, burns and reconstructive surgeries. The company’s Endoform Dermal Template is an FDA approved ready-to-use tissue substitute that can be used for wound care and dermal reconstruction. The product will improve the rate and quality of healing. Mesynthes is also developing Endoform Infection Control for the prevention of infection if there is a high risk of post-operative infection.

DUSA Pharmaceuticals, Inc. has announced that the United States Patent and Trademark Office (USPTO) has completed its re-examination of US Patent No. 5,079,262, “Method of detection and treatment of malignant and non-malignant lesions utilizing 5-aminolevulinic acid.” In its latest communication, the USPTO issued a Notice of Intent to Issue Ex Parte Re-examination Certificate which affirms the patent’s original seven claims and adds eight claims.

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Basilea Pharmaceutica Ltd. announces that following a request for re-examination from the Applicant Janssen-Cilag International NV (Janssen-Cilag), a Johnson & Johnson company, the European Committee for Medicinal Products for Human Use (CHMP) confirmed its previous negative opinion on the Marketing Authorization Application (MAA) for ceftobiprole for the treatment of complicated skin and soft tissue infections (cSSTI). The CHMP has confirmed its previous negative opinion on the use of ceftobiprole for the treatment of cSSTI.

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Medline Industries, Inc. has introduced Remedy® with Phytoplex™, a highly advanced skin care system for sensitive and damaged skin. A blend of the latest advances in biotechnology and molecular biology, Remedy® with Phytoplex™ is specifically designed and developed to nourish and soothe the skin, act as a structural moisturizer and help protect sensitive skin from free radical damage.

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NanoVibronix has announced that following its initial success with the first generation PainShield device for pain therapy, especially for the severe pain associated with Trigeminal Neuralgia, NanoVibronix presents its second generation PainShield with additional features for the therapy of chronic pain and wounds. PainShield is a small, portable device that produces low frequency, low intensity ultrasonic waves for healing of soft tissue such as tendon, chronic wounds and neuropathic pain.

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