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.
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.
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.
