• AEterna Zentaris Inc., of Quebec, said the data safety monitoring board recommended that patient recruitment for the ongoing Phase III trial in non-small-cell lung cancer be interrupted, based on a slow patient recruitment rate. The company said it believes it has reached a sufficient number of enrolled patients to enable the planned interim efficacy analysis planned at 320 events. As of Friday, a total of 260 events had occurred. The trial, sponsored by the National Cancer Institute, is evaluating Neovastat, an oral anti-angiogenic product to treat NSCLC in combination with radiotherapy and chemotherapy.

• Barrier Therapeutics Inc., of Princeton, N.J., said the FDA approved its Vusion (0.25 percent miconazole nitrate, 15 percent zinc oxide and 81.35 percent white petrolatum) ointment for the treatment of diaper dermatitis complicated by candidiasis in infants 4 weeks and older. Vusion is a steroid-free formulation containing the two main ingredients of diaper rash treatments, plus miconazole nitrate for treating infection.

• Genentech Inc., of South San Francisco, said its partner, F. Hoffmann-La Roche Ltd., of Basel, Switzerland, submitted a marketing authorization application to the European Medicines Agency for Herceptin (trastuzumab) as adjuvant treatment for early-stage HER2-positive breast cancer. This application is based on data from an international study showing that Herceptin given after standard chemotherapy significantly reduces the risk of cancer recurrence by 46 percent. Genentech filed a supplemental biologics license application with the FDA last week for the same indication.

• MediGene AG, of Martinsried, Germany, said its advanced prostate cancer drug, a luteinizing hormone-releasing hormone, was launched in France, triggering a milestone payment from the company’s marketing partner, Tokyo-based Astellas Pharma Inc. The drug now is offered in 11 European countries, and MediGene is entitled to royalties on all product sales.

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