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FDA OKs shortcut path for biosimilars
February 15th 2012The Food and Drug Administration has created the first shortcut to the U.S. market for “biosimilar” medicines - cheaper versions of expensive and complex biologic drugs such as infliximab for rheumatoid arthritis, etanercept for plaque psoriasis and psoriatic arthritis, and erythropoietin for anemia.
Off-label treatment with biologics effective for treating certain skin diseases
February 1st 2012Biologic drugs have proven to be of benefit for diseases where there is no indicated treatment, such as for immunobullous diseases. "Pemphigus vulgaris with rituximab (Rituxan, Genentech) has been a major advance, although this is not a formally approved indication for the drug," says Alan Menter, M.D., chief, dermatology, and chairman, residency program, Baylor University Medical Center, Dallas.
Lymphoma diagnosis may be missed without careful evaluation, multiple biopsies
February 1st 2012The cutaneous symptoms of lymphoma and atopic dermatitis (AD) can mimic one another, particularly when AD is severe. An accurate evaluation and assessment of the presenting clinical symptoms is crucial in avoiding a potential misdiagnosis of either disease.
Physicians continue to ponder best decision regarding Medicare participation
February 1st 2012Politicians on Capitol Hill once again have dermatologists - and all physicians who serve Medicare patients - wondering what in the name of common sense they are going to do. Just before Christmas, Congress delayed a 27.4 percent Medicare fee cut from its original Jan. 1 implementation date. The cut is now scheduled, barring any further congressional action, to take effect Feb. 29.
Favorable risk profile for botulinum toxin A supports expanding applications
February 1st 2012Even though botulinum toxin type A is one of the most potent neurotoxins known, its injection into muscles for the reduction of hyperfunctional lines is one of the safest procedures being performed in cosmetic dermatology. And the favorable risk-to-benefit profile of the toxin is fueling its use in an expanding number of off-label applications, says Thomas E. Rohrer, M.D.
Biologic agents relieve chronic skin conditions where other treatments fail
February 1st 2012Biologic therapies can help patients with dermatologic conditions, providing anti-inflammatory benefits without significant effects on other organ systems, says Steven R. Feldman, M.D., Ph.D., professor of dermatology, pathology and public health sciences, Wake Forest Baptist Medical Center, Winston-Salem, N.C.
Federal government's eRx incentive program criteria unambiguous
February 1st 2012In 2009, the federal government launched its Electronic Prescribing (eRx) Incentive Program. Although this program (which was authorized in the Medicare Improvements for Patients and Providers Act of 2008/MIPPA) is now three years old, physicians remain confused about the details. Fortunately, the eRx Incentive Program is straightforward.
Studying fine art enhances clinical observational skills
February 1st 2012Analyzing 18th and 19th century (Victorian-era) paintings can help dermatologists think beyond their established habits and preconceptions in the search for visual and other diagnostic clues, says Irwin Braverman, M.D., professor of dermatology, Yale School of Medicine.
New sunscreen labeling represents step forward in improving photoprotection
February 1st 2012Implementation of the final regulations from the Food and Drug Administration for sunscreen testing and labeling should enable consumer selection of effective sunscreen products. More work is still needed, however, to better educate the public about the damaging effects of UV exposure and to motivate appropriate sunscreen use, says Vincent A. DeLeo, M.D.
Safety profile of biologics evolves, but long-term risk concerns remain
February 1st 2012New safety profile data continues to emerge on biologics used in psoriasis. Among the findings: Today's biologics do not appear to increase serious infection risk; the drugs' short-term cancer risk profile is promising; but concerns remain about long-term cancer risk with all biologics and cardiovascular risk with interleukin-12/23, ustekinumab (Stelara, Janssen Biotech).
Inclusion/exclusion criteria for drug studies can be overly restrictive
February 1st 2012Drugs, by definition, are not safe. Exactly how safe a drug must be is a topic of much controversy. However, it is hard to determine the safety of many drugs because the inclusion/exclusion criteria for study protocols requires that the drug be studied in persons who are not pregnant or lactating and who are usually above the age of 12, and in those who have normal test results and normal physical exams.
Biologics' potential for side effects calls for thorough patient medical history, prescreening
February 1st 2012Biologics may provide excellent relief from psoriasis, but that relief comes with the potential for serious side effects, mainly associated with an altered immune system. As a result, Kevin Cooper, M.D., emphasizes the importance of making sure patients are physically and mentally prepared for undergoing biologic therapies.
Hair restoration research explores multiple uses for embryonic-like protein-rich media
February 1st 2012A naturally secreted, embryonic-like human cell conditioned media (hCCM) used as a follicle holding solution (FHS) holds promise for improving outcomes of hair transplantation surgery, according to clinical trial findings reported by Neil S. Sadick, M.D., at the 2011 annual meeting of the American Society for Dermatologic Surgery.