FDA Approvals & News
New Intense Pulsed Light System Cleared
The FDA gave clearance to a new intense pulsed light system from Candela Corporation. The Ellipse Flex IPL system was developed to treat photodamage, vascular lesions, telangiectasia, acne, and diffuse erythema.
This device has a programmable pulse mode, according to the company, which enables clinicians to fine tune and customize the settings to fit almost any treatment situation.
The Ellipse Flex IPL is also equipped with the company’s dual-mode filtering technology that “removes potentially harmful water absorbing wavelengths from the output spectrum device,” according to the company.

Anti-Fungal NDA
The FDA has accepted a new drug application for a new treatment for seborrheic dermatitis. Barrier Therapeutics submitted an NDA for ketoconazole USP 2% topical gel (Sebazole) for the non-steroidal management of seborrheic dermatitis, a condition affecting 3% to 5% of the U.S. population — or up to 14.3 million people.
Sebazole is the second drug that Barrier Therapeutics has under review by FDA. The company also has an NDA under review for 0.25% miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum ointment (Vusion), formally known as Zimycan. This drug is under review for the indication of treating diaper dermatitis complicated by candidiasis. n

Recall on Methotrexate
One lot of methotrexate for injection (preservative-free), USP 1 gram per vial is being voluntarily recalled by Bedford Laboratories of Bedford, OH. The active drug substance used to manufacture the recalled lot was found to contain low levels of ethylene glycol. No levels of ethylene glycol are permitted to be delivered intrathecally to humans. No adverse events have been reported to date.
The product in question is NDC 55390-143-01, lot #859142, which has an expiration date of 9/07. For questions concerning this recall, contact Bedford Laboratories at (800) 562-4797. n

Bacterially-Contaminated OTC Product
The FDA has issued a warning concerning the products Miracle II Neutralizer and Miracle II Neutralizer Gel, which are promoted by the manufacturer, Tedco, Inc., as treatments for dermatitis, diaper rash, psoriasis, mouth ulcers, herpes, skin cancer, and many other conditions. FDA has found that these products are bacterially contaminated and have not been proven safe and effective.
In addition, Tedco has been notified by the FDA about the bacterial contamination but has declined to voluntarily remove its products from the market. These products are sold worldwide and via the Internet as well as in numerous stores. To report any adverse events related to these products, contact MedWatch at (800) FDA-1088 or online at www.fda.gov/medwatch/report.htm.

Melanoma Still on the Rise
A new report from the National Cancer Institute (NCI) offers a report card on the progress made with different cancers with respect to the mortality and morbidity of these diseases. Melanoma is still not making the grade.
According to the NCI’s “Cancer Trends Progress Report – 2005 Update”, melanoma is still one of several cancers with an increasing number of cases. Other cancers that have an increased incidence include cancers of the breast in women and of the prostate and testes in men, as well as leukemia, non-Hodgkin lymphoma, myeloma, and cancers of the thyroid, kidney and esophagus.
However, on a positive note, the “Cancer Trends Progress Report” found that people are doing slightly more to protect themselves from the sun.

Pay for Performance Measures
The Institute of Medicine (IOM) proposed the need for a new federal office, The National Quality Coordination Board, within the Department of Health and Human Services to head up the development of quality measures for pay for performance, public reporting, accreditation or any other quality improvement effort.
According to an American Medical News report, the IOM recommended this board in a report released in December detailing a plan to adopt and develop performance measures. The researchers concluded that several good sets of measures do already exist, but explained that the measures are “too numerous and spread out to be effective.” The IOM’s goal in setting up this board is to make it easier on doctors because Medicare, Medicaid, private insurers and review boards would share a set of reporting guidelines.
The next step for the IOM is to convince Congress about the need to create the National Quality Coordination Board. The IOM wants the board to function independently, according to the American Medical News article, so that is doesn’t function as a government-run operation from the top down.
In the meantime, the IOM panel endorsed a starter set of quality measures that could be used by multiple payers to assess doctors and others. For outpatient care, the IOM recommended the 26 guidelines adopted by the Ambulatory Care Quality Alliance earlier in 2005. The IOM also wants doctors to be evaluated on patient assessment of care. This information, collected through the CAHPS Clinician and Group Survey, would evaluate how well doctors provide quick, needed care while maintaining good communication with patients.

In Brief
Dusa Pharmaceuticals Inc., Announced… that it has signed a definitive merger agreement to acquire all of the common stock of Sirius Laboratories Inc., in exchange for cash and common stock worth up to $30,000,000. Upon closing of the transaction, the company will be offering an expanded line of products to dermatologists, while also enhancing its near-term development pipeline.

CollaGenex Pharmaceuticals Announced…that it had entered into a definitive agreement to acquire all the shares of SansRosa Pharmaceutical Development Inc. SansRosa is the assignee of various patent applications covering innovative methods for the treatment of redness associated with rosacea and other skin disorders.

Foamix Ltd., Announced the Receipt…of its third U.S. patent for its OilGel, which exhibits a semi-solid state upon standing and transforms to liquid state when rubbed onto the skin or applied to the eyes. The property allows for application of pharmaceutical and cosmetic preparations as semi-solid that can be rubbed, spread and rapidly absorbed. It’s intended as a delivery system for medicated actives for the treatment of skin and eye diseases.

Photo Therapeutics Limited Opened…a new facility in Lake Forest, CA, in order to manage the growth in demand in the United States for its Omnilux range of LED technology. This office will manage the marketing and selling activities within North America, as well as the U.S.-based clinical trial program. The facility will also house service and support engineers.

PhotoMedex CEO Named…LifeSciences CEO of the Year. Jeffrey O’Donnell was recognized by the Eastern Technology Council at its 13th Annual Enterprise Awards ceremony held Nov. 1 in Philadelphia. Mr. O’Donnell was selected from CEO nominees in Greater Philadelphia & Central-Eastern Pennsylvania by a panel of judges comprised of local community and business leaders.

Mack Molding Company and Transport Pharmaceuticals Announced…that they have entered into an agreement to provide development services for Transport’s proprietary device/drug combination system that will be used to treat cold sores (herpes lavialis), currently in Phase III trials.

NIH Rolls Out…electronic grant submission business. Soon grant application packages on paper will be a thing of the past as NIH readies to receive grant applications electronically through the federal portal of grants.gov. Beginning on Dec. 1, the NIH now required all its SBIR/STTR grant applicants to electronically submit their competing grants. NIH plans to transition all of its competing grant programs one by one from paper to electronic versions by May 2007.