Johnson & Johnson Pharmaceutical Research & Development has announced that it received a Complete Response letter from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for ceftobiprole for the treatment of complicated skin and skin structure infections, including diabetic foot infections. The FDA has indicated that they cannot approve the NDA for ceftobiprole at this time. They have asked J&JPRD to conduct additional audit work of clinical investigator sites and to address specific questions related to site monitoring.

LEO Pharma has launched a new treatment gel Xamiol® for scalp psoriasis. This gel formulation contains the proven combination of the Vitamin D analogue calcipotriol 50 microgram/g (as monohydrate) and the corticosteroid betamethasone 0.5 mg/g (as dipropionate). It is indicated for once-daily topical treatment of scalp psoriasis in adults and is recommended for four weeks and thereafter repeat treatment can be initiated under medical supervision. Xamiol®, an almost clear and odourless gel, differs from traditional scalp psoriasis treatments.

Dermipsor Ltd. has reported detailed analysis of the results for the Phase 2b clinical trial of its product DPS-101. To be used in the treatment of psoriasis patients, DPS-101 is a new topical non-steroidal combination drug. It is a mix of two active ingredients – calcipotriol and nicotinamide. The multi-centre trial included 168 bilateral patients. Each side of the body of these patients was treated separately to evaluate the effectiveness of various doses of the medication. At the end of this 12 week study, half of the patients who received the highest dose of the drug achieved a condition of “clear to almost clear”. This is a significant improvement as compared to placebo.