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Abbott Withdraws Application for Briakinumab
Due to a reported elevated risk for cardiac events associated with the investigational biologic, Abbott Laboratories has withdrawn its US biologics license application (BLA) and European marketing authorization application (MAA) for briakinumab (ABT-874), an anti-IL-12/23 monoclonal antibody for the treatment of psoriasis. Recent clinical trial data reportedly uncovered the elevated risk. “Briakinumab is a highly effective agent for patients with moderate to severe psoriatic disease,” said Jerry Bagel, MD, director of the Psoriasis Treatment Center of Central New Jersey in East Windsor. “Previous trials indicate that more than 90 percent of patients receiving briakinumab achieved PASI 75,” he said. “Despite this encouraging efficacy data, recent concerns over the apparent increased likelihood of major cardiac adverse events with briakinumab remind of the importance of exercising caution with other biologics as well,” noted Dr. Bagel.

In a filing with the Securities and Exchange Commission, Abbott said that following feedback from regulatory authorities indicating the need for further analysis and the potential for additional studies, the company plans to evaluate next steps for briakinumab, including potential resubmission at a later date.

Melanoma Clinics an Essential Asset in Diagnosis
Individuals at high risk for melanoma no doubt need regular follow-up, but a recent study says it should be at a melanoma center or qualified institution (Archives of Dermatology E-pub Jan 17). Investigators retrospectively reviewed data from 201 melanoma patients divided into two groups: those who received a diagnosis while being followed, repeatedly, in the clinic program for high-risk patients and those diagnosed after a referral to the clinic because of suspicious skin lesions. Investigators found that 70 percent of melanomas diagnosed in patients in the follow-up program were in situ, compared with 27.9 percent of those in the referral group. Also, the Breslow index was significantly lower in the follow-up group than in the referral group, with a mean of 0.55 vs. 1.72 mm (P<0.001).

Interestingly, most of the melanomas diagnosed in the follow-up group did not match some of the clinical or dermoscopic features characteristic of melanoma, and only 12 percent met all four of the ABCD criteria. In contrast, 63.6 percent of the melanomas detected in the referral group met the criteria.

New Statistics on Hair Restoration Procedures
The International Society of Hair Restoration Surgery recently released its report on 2008 practice census facts and figures, which indicated that hair procedures are on the rise. An estimated 252,002 hair restorations were performed worldwide in 2008, a 12 percent increase from 2006. A total of 98,727 of those were performed in the US. The report estimates the worldwide market for hair restoration procedures to be worth $1,268,590,668. Notably, the report also showed that more than half of both female and male patients were between the ages of 30 and 49.

Calling Dermatologists
A Southern California non-profit group is seeking a dermatologist to join its upcoming medical mission to Nicaragua from August 4-14, 2011. International Medical Alliance (IMA) recruits doctors from every medical discipline to volunteer, both in the US and overseas. The IMA has already assembled a team of more than 60 doctors, nurses, dentists, and support personnel for the trip. For more information: www.internationalmedicalalliance.org.

FDA Updates Device Review Process
FDA announced a series of steps it will take this year to streamline the review of medical devices. The agency also said it will create an internal council to “assure timely and consistent science- based decision making.” Notably, regulators said they would delay a decision on the most drastic proposals, which would give the government new power to police device makers. Those proposals, widely supported by public safety advocates, included clarifying the FDA's power to revoke approval for products that prove unsafe or ineffective. Another key proposal would have established a new subset of devices that would require more medical data to gain approval. The FDA said it would wait for the guidance of the Institute of Medicine before making a final decision on more sweeping changes.

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