Genentech resolves its long-standing dispute with MedImmune over its Cabilly patent, which relates to the process for producing antibodies, the biotech announces. MedImmune, which licenses the patent along with Johnson & Johnson, ImClone and Abbott, filed suit in 2003 challenging the patent, but it was not until a decision by the U.S. Supreme Court in January that the firm gained the necessary legal standing (1"The Pink Sheet," Jan. 15, 2007, p. 7). Under the settlement, the manufacturer of Synagis (palivizumab) can obtain licenses for certain additional pipeline products under the Cabilly patent family, including motavizumab. Financial terms of the settlement were not disclosed
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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Kumar takes over as acting director of the Center for Biologics Evaluation and Research’s Office of Therapeutic Products days after director Nicole Verdun was ousted.
While treatments for scleroderma are in development, none are approved for the condition that is associated with high morbidity and mortality. The European Medicines Agency says guidance on how to design development programs for the disorder is needed.