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GLG News by Physicians who Treat Malignant Melanoma (US)

Eric Whitman, MD, Medical Director, Office of Grants and Research
Eric Whitman, MD, Medical Director, Office of Grants and Research
Atlantic Health System Inc
Analysis of: FDA Approves Wyeth's Torisel For Treatment Of Advanced Kidney Cancer (www.medicalnewstoday.com)
Torisel is the first mTor drug approved for any indication that I am aware of. Like Sorafenib and Sunitinib, it blocks a biochemical pathway thought to be critical to malignant cell development and survival. These drug are all slightly different and clinically they are probably not direct competitors....
Eric Whitman, MD, Medical Director, Office of Grants and Research
Eric Whitman, MD, Medical Director, Office of Grants and Research
Atlantic Health System Inc
Analysis of: Digital Diagnosis: New Tool for Detecting Skin Cancer (www.ehponline.org)
Melafind is currently undergoing Phase III testing. If these results are positive (and I cannot comment on the trial since I do not know any of the details) then presumably the device will be approved. If practitioners cannot be reimbursed for its use by insurance companies, it will be difficult...
Sunil Dhawan, MD, Clinical Assistant Professor of Dermatology
Sunil Dhawan, MD, Clinical Assistant Professor of Dermatology
Stanford University
Analysis of: Digital Diagnosis: New Tool for Detecting Skin Cancer (www.ehponline.org)
If Melafinds phase three study results are positive then physicians will in general be receptive. The only issues are: 1. Ease of use/time to scan 2. Ability for non physician personnel to be trained to use the technology. 3. cost 4. Insurance reimbursement The technology may have more use at larger...
Sunil Dhawan, MD, Clinical Assistant Professor of Dermatology
Sunil Dhawan, MD, Clinical Assistant Professor of Dermatology
Stanford University
Analysis of: No Hydroquinone, Means No Worries for Modus. Dr.’s Applaud Europe’s New Import To Fight Signs of Aging (www.rushprnews.com)
The new Modus product "without hydroquinone" cannot be fully evaluated on the basis of the currently available information. Decisions based on the opinions of a "Beauty Editor", and 6 years worth of studies with only 4 patients, are tenuous at best, and laughable at worst. It will be difficult to unseat...
Sunil Dhawan, MD, Clinical Assistant Professor of Dermatology
Sunil Dhawan, MD, Clinical Assistant Professor of Dermatology
Stanford University
Analysis of: FDA May Place Ban on OTC Bleaching Creams (www.carefair.com)
The possible ban of over the counter hydroquinone skin bleaching agents may be premature. We have used these agents for 20 years without any significant side effects including ochronosis or paradoxical darkening of the skin. These agents are only modestly effective at best. Most patients still...
Eric Whitman, MD, Medical Director, Office of Grants and Research
Eric Whitman, MD, Medical Director, Office of Grants and Research
Atlantic Health System Inc
Analysis of: Panel Endorses New Anti-Tumor Treatment (www.therapeuticsdaily.com)
Provenge was shot down by the FDA this month. This active specific immunotherapy for advanced prostate cancer failed to reach any of its primary or secondary endpoints. The survival "benefit" touted in the lay press is likely a statistical anomaly but a large scale study is pending (if the company ...
Analysis of: Dendreon shares plunge on cancer drug blow (news.moneycentral.msn.com)
Stock was up on preliminary FDA approval, however, the FDA has mandated that final approval would be dependent on ongoing trial.    This will certainly delay any growth for Dendreon/Provenge at this time.  
Sunil Dhawan, MD, Clinical Assistant Professor of Dermatology
Sunil Dhawan, MD, Clinical Assistant Professor of Dermatology
Stanford University
Analysis of: Ceragenix Announces Results from Phase IV Study of EpiCeram(TM) Meet All Primary and Secondary Endpoints (www.irconnect.com)
The recent Epiceram phase 4 data comparing it to Cutivate are positive, and bode well for the product. The concept of barrier repair makes sense in light of the recent findings in regards to the genetic basis of atopic dermatitis. Repairing the barrier with Epiceram will reduce inflammation, and the...
Sunil Dhawan, MD, Clinical Assistant Professor of Dermatology
Sunil Dhawan, MD, Clinical Assistant Professor of Dermatology
Stanford University
Analysis of: FDA Approves Antibiotic Ointment For Children And Adults - Altabax (retapamulin Ointment) (www.medicalnewstoday.com)
Altabax (retapamulin) will be a competitive topical agent for impetigo because it is a new molecular entity, Bactroban or mupirocin is generic and cannot compete directly, and it is indicated for children as young as 9 months. The market for a nonoral antibiotic is always good, due to lower side ef...
Sunil Dhawan, MD, Clinical Assistant Professor of Dermatology
Sunil Dhawan, MD, Clinical Assistant Professor of Dermatology
Stanford University
Analysis of: Anika Gets CE Mark Certification For Commercial Sale Of Cosmetic Dermatology Product, ELEVESS In European Union (www.tradingmarkets.com)
ELEVESS received its CE mark approval in Europe. The product is entering a crowded field with no real differentiating factors other than having lidocaine as an anesthetic. To release this product in the US without a partnership with an established company will be very hard. It will not be easy to compete...

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