In BriefAnika Therapeutics, Inc announced… that it is in negotiations to terminate its license and supply agreements entered into with Galderma regarding the development and commercialization of the ELEVESS family of products. The dispute leading to the decision concerns certain aspects of the formulation of the current and future products as well as some elements of the strategy for commercialization. With an enhanced product that is now approved in the United States, European Union and Canada, the Company is seeking a new partner and expects to launch the product as soon as possible in 2008 alone or with a new partner.Isolagen, Inc. announced… the initiation of a Phase III clinical program to investigate Isolagen Therapy for the treatment of moderate to severe acne scars. Isolagen also has a pivotal Phase III clinical program underway to evaluate the Isolagen Therapy in treating nasolabial folds, or wrinkles.Stiefel Laboratories, Inc. announced… it has entered into an arrangement with Allergan, Inc. to develop, manufacture, distribute and promote dermatological products containing tazarotene.Under the terms of the transaction, Stiefel will utilize Allergan’s proprietary technology and tazarotene in several different ways. Stiefel’s U.S. sales force will co-promote Allergan’s TAZORAC (tazarotene) to dermatologists. Stiefel also will capitalize on its existing patent-protected technology and Allergan's innovative tazarotene compound to bring unique therapeutic options to market for a common dermatological disease. NEWS & TRENDS Medicare to Slash Physician Payments by 10.1%Unless Congress intervenes, on Jan. 1, 2008, the Centers for Medicare & Medicaid Services (CMS) will institute its final 2008 Medicare physician fee schedule rule, which will cut physician payments by an average of 10.1%. This percentage will vary by specialty, practice and geography According to American Academy of Dermatology President Diane Baker, M.D., speaking at the recent annual meeting of the American Society of Cosmetic Dermatology & Aesthetic Surgery, dermatologists would realize an 8% cut in reimbursement. Other specialties, such as anesthesiologists, for example, would get a 4% boost because of changes in their practice costs formula, while net cuts for nephrologists could be as high as 13%. The impact of an updated geographic adjustment factor — an index of work and liability costs — to benchmark physician operating costs around the country, would also be felt variably. The rule also lists the 74 quality measures to be used in the Physicians Quality Reporting Initiative in 2008 and delays finalizing most of the latest revised physician self-referral, or “Stark,” rules. Scientists Sequence Genome of Dandruff-Causing FungusP&G Beauty scientists have successfully sequenced the complete genome for Malassezia globosa (M. globosa), a naturally occurring fungus responsible for the onset of dandruff and other skin conditions in humans.M. globosa, a common fungus that lives on the skin of humans, feeds on fatty external lipids. The sebum and other lipids humans secrete onto the scalp create a prime environment for M. globosa. Symptoms of dandruff and seborrheic dermatitis occur when, combined with a genetic susceptibility for an inflammatory response, both sebum and M. globosa are present on the scalp. Malassezia, which contributes to many health issues was little understood before this research. The genetic sequencing of M. globosa has expanded the range of potential treatment targets from a few observational characteristics to now more than 4,000 molecular targets. Promising New Drug Attacks Melanoma DifferentlyA novel, injectable, investigational drug candidate from Synta Pharmaceuticals Corp, in combination with the chemotherapeutic agent paclitaxel, has shown promise in patients with metastatic melanoma by delaying disease progression and prolonging their lives.STA-4783 kills cancer cells by elevating oxidative stress levels beyond a breaking point, triggering apoptosis. In preclinical models, STA-4783 showed potent killing of a broad range of cancer cell types at high doses and an ability to strongly enhance the efficacy of certain chemotherapy agents, with minimal additional toxicity, at moderate doses. Clinical TrialsA 21-center, double-blind, randomized, controlled Phase IIb clinical trial conducted by Synta Pharmaceuticals Corp., included 81 patients with metastatic melanoma among which 28 received treatment with the chemotherapy drug paclitaxel alone and 53 received paclitaxel plus the new drug, STA-4783. Those receiving the combination met the primary endpoint — doubling the median time patients survived without their disease progressing — compared to paclitaxel alone (p=0.035). The median progression free survival was 1.8 months in the group that got chemotherapy alone, but 3.7 months in the group that received the combination. In addition, progression-free survival was linked to improvements in overall survival. Patients on the experimental combination survived on average for 12 months after being diagnosed, while those getting only paclitaxel survived on average 7.8 months. The study also indicated that STA-4783 might boost the efficiency of chemotherapy drugs that induce apoptosis because it appears to lower the hurdle for activating that process. Massachusetts Medical Board Takes Lead in Regulating Medical SpasIn a move that other states might do well to follow, Massachusetts has created an effective mechanism to oversee its portion of the more than 1,000 medical spas that have sprouted up all around the United States in recent years. Created by state law in 2006, its medical spa taskforce may draft standards and regulations and make recommendations to state legislators. State Medical Board EffortsAs the Federation of State Medical Boards (FSMB) has no guidelines on medical spas, the onus has been on individual state medical boards to attempt to regulate services at medical spas to ensure that patients are safe and that physicians perform or supervise certain procedures properly. Florida and California, for example, have regulations on Botox injections and laser hair removal. The Kansas State Board of Healing Arts adopted its laser regulations in 2001 and was recently foiled in its efforts to ban another cosmetic procedure involving the injection of a compound to dissolve fat.Need for OversightYet as negative press mounts — including the death of a North Carolina college student who died in 2005 days after she applied anesthetic gel to her legs to prepare for laser hair removal — so does pressure to create more effective measures of oversight.Although it has no official guidelines, the FSMB is raising awareness about medical spas.