FDA Approvals & NewssBLA Accepted for RemicadeThe FDA has accepted a supplemental biologics license application (sBLA) for infliximab (Remicade) for broader indication in treating patients with psoriatic arthritis. According to Centocor, the sBLA is for inhibiting progression of structural damage and improving physical function in patients with active psoriatic arthritis. The filing for this sBLA is based on data obtained during the IMPACT 2 trial. During this double-blind, placebo-controlled 1-year-long study, researchers found that treatment with infliximab resulted in significant inhibition in the progression of structural damage when compared with placebo. Improvements were measured by radiographic analyses as well as by the Health Assessment Questionnaire. Radiographic changes were measured in van der Heijde-Sharp (vdH-S) score — lower scores indicate less structural damage; higher scores mean greater damage. As early as 24 weeks, infliximab-treated patients experienced a mean change in vdH-S score of -0.70 (+/- 2.53) from baseline compared with an average change of 0.82 (+/- 2.62) in the placebo group (P<0.001). Patients who underwent treatment for the entire study as well as patients who initially received placebo and later received infliximab experienced a total improvement of -0.24 (+/- 2.45) and -0.29 (+/-1.98) respectively, from weeks 24 to 54. Health Assessment Questionnaire results, which measure the difficulty patients have in completing tasks in eight functional areas, indicated that as early as 14 weeks patients who had received infliximab experienced a median improvement of 43%, compared with zero improvement in the placebo group. At week 54, the percentage of improvement had increased to 50% for the infliximab group and had climbed to 46% for the placebo group, in which patients had crossed over and had begun receiving infliximab therapy atweek 24. Treatment for Pemphigus VulgarisThe FDA has granted orphan drug designation for mycophenolate mofetil (CellCept) for the treatment of pemphigus vulgaris. According to Aspreva Pharmaceuticals and Roche, CellCept is presently undergoing evaluation as a treatment for pemphigus vulgaris in a Phase III study involving 77 patients with active pemphigus vulgaris who are being followed for 52 weeks. After completing the study, which is expected to be done in 2007, the companies will then use the data to support a supplemental new drug application for CellCept for the indication to treat pemphigus vulgaris.  News Tracking Insurance PaymentsIf you’re like many dermatologists, you’ve had your fair share of troubles collecting payments from health insurers. Now you can commiserate, or avoid the worst offending insurers, by viewing rankings of insurers on a new Web site. On www.athenapayerview.com, health plans are ranked by breaking down which insurers are the most responsive to physicians and which are not.The system, PayerView, reviews the performance of insurers, including payment speeds, denial rates, adherence to national standards and more. The numbers are based on performance in seven areas, including: days in accounts receivable, first pass pay rate, percent patient liability, denial rate, percent phone call, percent not on file, and percent unclear, zero paid.Data were based on actual provider activity captured in the fourth quarter of 2005 by athenahealth that involved analysis of about 5 million charge lines. To be included, national payers were required to have at least 10,000 charge lines and 3,000 for regional payers. Each measure was weighed with priority placed on fast, complete payment. The rankings will be updated on a quarterly basis on the Web site as a free service. For more, visit www.athenapayerview.com. Lice Resistant to TreatmentArecent study published in the Archives of Disease in Childhood found that four out of five head lice are now resistant to malathion, permethrin and phenothrin, the pesticides most commonly used to treat them. Researchers screened almost 3,000 children selected randomly from 31 schools across Wales and found about 8% were infected with lice. The researchers sent 316 samples of head lice obtained from these infested children for analysis. They found that 82% tested positive for pyrethroid-resistance genes, which code for a sodium channel that will not bind to pyrethroid, protecting the bug’s nerves.Researchers suggest that parents should try products containing silicone-based insecticides or organophosphates as a first-line therapy to treat lice.  Senators Address iPLEDGE ConcernsThe American Academy of Dermatology and the American Academy of Dermatology Association (Academy) recently commended U.S. Senators Judd Gregg (R-NH) and Dick Durbin (D-IL), along with senators from both political parties, for contacting the FDA regarding concerns with the iPLEDGE program. Stephen P. Stone, M.D., President of the Academy, in a recent statement said, “The Academy appreciates the actions of Senators Gregg, Durbin and others to bring awareness of this issue to the forefront of the FDA in order to ensure patient safety.”Under iPLEDGE, the regulatory program for isotretinoin (Accutane, Amnesteem, Claravis, Sotret), prescribers, patients, pharmacies, wholesalers and manufacturers are required to participate in a mandatory registry in an effort to prevent female patients of childbearing age from using the drug during pregnancy in order to prevent birth defects.Since its implementation in March, iPLEDGE has had numerous flaws and inefficiencies. Concerns include a mandatory 7-day timeframes for picking up a prescription, a subsequent 23-day lockout period and a 30-day period between office visits that has led to gaps in therapy. Some other concerns are the inclusion of male patients and female patients not of childbearing age. Despite the Academy’s numerous requests to the FDA to address the issues, many still remain.In their letter to the FDA, Senators Gregg and Durbin, along with others, urged Acting Commissioner of the FDA, Andrew Eschenbach, M.D., to address problems associated with the implementation of the iPLEDGE program. Gregg is the former chairman of the Senate Health, Education, Labor and Pensions Committee and Durbin serves on the Senate Appropriations Subcommittee on Health and Human Services. Both Senators support the risk-management goals of the program. In Brief...Thermage Recently Introduced… Thermage PatientBuilder.com, an online marketing resource. The site was designed to provide customers with customizable advertising agency quality materials. The materials, including recently launched Body by Thermage and Eyes by Thermage marketing campaigns, are based on consumer research Thermage conducted over 12 to 14 months.Connetics Corporation Announced… it has named Tim Pergram to the position of Regional Sales Director and that it has named Cynthia Canup to the position of Director, Sales Training.Genentech, Inc. Announced…that it recently donated more than $21 million to various, independent, non-profit public charities that will provide financial assistance to eligible patients who cannot access the treatment they need due to out-of-pocket costs. The donations will support patients with a number of diseases, regardless of the therapy they are receiving.Ferndale Laboratories Announced… that is has entered into a co-promotion agreement with Watson Pharmaceuticals, Inc. to promote their anogenital wart treatment, Condylox (podofilox gel and solution) 0.5%.