Syneron’s Device for Laser-Assisted Lipolysis FDA Cleared

Syneron Medical received U.S. Food and Drug Administration clearance for its LipoLite device for laser-assisted lipolysis and other dermatological procedures.

According to the manufacturer, the compact LipoLite system is a minimally invasive alternative and a complement to traditional liposuction fat-removing procedures that is comfortable for physicians to use and upgradeable to support future applications. The procedure is said to require only local anesthetic and is designed to provide patients with lasting results with little downtime and a high level of safety. According to the manufacturer, LipoLite’s OptiPulse technology, which utilizes two pulse energy levels and pulse repetition rates, optimizes the mechanical breakdown of target tissue and the thermal destruction of fat cell membranes during procedures.

ANTHELIOS 40 Broad-spectrum Sunscreen Receives FDA Approval

FDA approval for outdoor use has been granted to La Roche-Posay’s sunscreen Anthelios 40, which the company claims has the highest photostable UVA and UVB protection available in a sunscreen.

The newly approved sunscreen contains the highest concentration of Mexoryl SX, the organic, stable sun filter designed to protect skin from the short UVA waves and provide enhanced overall UVA protection. It also combines 5% titanium dioxide (an inorganic sun filter) with 2% avobenzone (an organic sun filter) to provide complete broad spectrum protection. Additional sun filter ingredients include a patented stabilized combination of avobenzone (Parsol 1789) and octocrylene to provide coverage against UVB waves and long UVA waves.

Anthelios 40 was specifically tested for safety on those who have the photosensitive skin disorder polymorphous light eruption, and has been shown to maintain activity for up to 5 hours in laboratory testing. Its efficacy and safety is supported by 87 non-clinical toxicology studies, 29 clinical studies (including 21 clinical pharmacology studies) tested on more than 2,500 patients.

MedSurge Advances and Osyris Granted 510 Clearance for New Laser-Assisted Lipolysis Device

The FDA) has granted 510(k) clearance to MedSurge Advances and French laser manufacturer Osyris for a new laser-assisted lipolysis device for the reduction of localized fat deposits and skin contraction. The technology, known as Lipotherme, is a 980-nm continuous wave diode laser that can be adjusted from 6 watts to 25 watts of power.

Laser-assisted lipolysis using this and other such devices is appropriate for treating the face, chin, back, abdomen, arms, inner thighs and upper knees.

OTHER DRUG NEWS Pfizer Melanoma Drug Halted

Pfizer Inc., has halted a late-stage study of tremelimumab, its experimental drug for advanced melanoma, after data showed it offered no advantage over standard chemotherapy.

However, the company does not intend to abandon tremelimumab nor its new focus on oncology. A company spokesperson said Pfizer will continue to assess the tremelimumab study data to understand the clinical benefit seen in some patients who received the drug, and to focus on additional studies involving tremelim-umab alone and in combination with other therapies, which are currently ongoing in patients with several types of cancer.

Medarex and Bristol-Myers Squibb Delay Ipilimumab BLA

After a meeting with the FDA, which requested additional overall survival data to further demonstrate the benefit of ipilimumab, Medarex, Inc., and Bristol-Myers Squibb Company have decided to delay their biologics license application submission for this investigational immunotherapy for patients with advanced metastatic melanoma.

Revised timelines are under development, but a BLA for ipilimumab will not be submitted to the FDA this year.

IN BRIEF

THE WOMEN'S DERMATOLOGIC SOCIETY HONORS… Janet G. Hickman, M.D., with its Rose Hirschler Award, which is named after the first woman dermatologist in the United States.

JSJ PHARMACEUTICALS, INC., ANNOUNCES… the introduction of its new aesthetic division, Vitivia, which will focus on medically based aesthetics and the development of science-based, result-oriented products.

MEDINOTES IS ACQUIRING… Bond Technologies, which adds to its capabilities NET-based EHR and practice management solutions such as e-prescribing, patient portals, patient kiosks, and image management.

CICATRICIAL ALOPECIA RESEARCH FOUNDATION IS CALLING FOR… research grant submissions. Researchers worldwide are being asked to submit proposals for research grants for awards ranging between $5000 and $20,000.

Ferndale’s Poisonous Plant Poster Again Available For the third year, Ferndale Laboratories, Inc., is offering dermatologists its popular poisonous plant poster to help their patients identify three of the most common poisonous plants.

The self-adhering poster targets patients who have already or may come into contact with poison ivy, poison oak or poison sumac this summer. Designed for waiting room display, it features vivid representations of specific poisonous plants, with full-color photographs, and highlights important information about where the plants may be found, what symptoms look and feel like, and how to prevent contact with these plants.

Posters plus tear pads containing 25 individual handout sheets are available at no cost by contacting your Ferndale sales representative or calling Ferndale directly at 877-352-6295 while supplies last.

Stiefel Gives Back with Support for Skin Disease Foundations Children's Skin Disease Foundation and Epidermolysis Bullosa Medical Research Foundation receive Stiefel funding Stiefel Gift ensures Future of Camp for Kids with Skin Diseases

Thanks to a Stiefel Laboratories gift to the Children’s Skin Disease Foundation (CSDF), the future of its camp for children with severe chronic and/or fatal skin diseases is secure through 2012.

Camp Wonder — which is free of charge for children with serious and fatal skin diseases — is the only medically staffed camp in the Western United States for children with skin diseases. About 80 children participate in the week-long camp considered to be the signature program of CSDF.

A non-profit, 501(c)(3) organization that raises money to fund medical research for better treatment and possible cures of skin diseases that affect children, CSDF was founded in 2000 by then California teenager Francesca Tenconi, a pemphigus foliaceous sufferer, with Drs. Jenny Kim and Stefani Takahashi, dermatologists at the David Geffen School of Medicine at UCLA, who continue to serve as the camp’s medical directors.

Stiefel’s involvement dates back to 2006, when it acquired Palo Alto, California-based Connetics Corporation, which was already deeply involved in the Foundation led by Ms. Tenconi, now a pre-med student at the University of Pennsylvania, and her parents.

In 2007 Stiefel Laboratories, Inc., pledged a $125,000 endowment to CSDF, which guarantees Camp Wonder will run at capacity for the next 5 years.

Stiefel Teams Up with Celebrities to Endow Epidermolysis Bullosa Medical Research Foundation

Stiefel Laboratories, Inc., recently agreed to donate up to $1 million in matching funds to benefit the Epidermolysis Bullosa Medical Research Foundation. The pharmaceutical company’s offer came in response to a challenge posed by television star Courtney Cox and husband David Arquette to raise $1 million for the foundation in 2 weeks. Pledges were made at the invitation-only celebrity fundraiser at Eva Longoria Parker’s new Hollywood restaurant, Beso.