Genmab A/S announced that Genentech and Biogen Idec have filed for a re-hearing en banc (i.e. before all judges of the court) in the appeal case, where the U.S. Court of Appeals for the Federal Circuit recently upheld the U.S. District Court's judgment in favor of GlaxoSmithKline plc (GSK). The appeal case relates to a patent infringement case involving Arzerra® brought against GSK by Genentech and Biogen Idec. Genentech and Biogen Idec claim that the decision from the US court of appeals announced on April 16, 2013 in favor of GSK was against court precedent and request the US court of appeals to reconsider the case. The court of appeals will now decide whether to grant the rehearing. Genentech and Biogen Idec originally filed the lawsuit in 2010 in the U.S. District Court for the Southern District of California claiming that Arzerra infringed U.S. Patent No. 7,682,612 covering methods of treating Chronic Lymphocytic Leukemia (CLL) with CD20 antibodies. GSK denied infringement and claimed the patent was invalid and unenforceable. An initial judgement by the court in favor of GSK in December 2011 was subsequently appealed by Genentech and Biogen Idec. In April 2013 the US court of appeals upheld the original decision by the US district court in favor of GSK.

GlaxoSmithKline plc announced that it is cutting 14 jobs at its Dublin-based commercial division. Some of the redundancies will probably be mandatory, though the company will look for volunteers. Staff have been informed of the cuts but no one has been formally let go yet. It plans to reduce costs by at least £1 billion a year by 2016. It recently announced 94 job losses at its Cork shared services operation. The multinational employs around 1,600 people in Ireland.

GlaxoSmithKline plc and Theravance Inc. announced that the US Food and Drug Administration (FDA) has approved BREO ELLIPTA as an inhaled long-term, once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. It is also indicated to reduce exacerbations of COPD in patients with a history of exacerbations. BREO ELLIPTA is a combination of the inhaled corticosteroid (ICS), fluticasone furoate "FF", and the long-acting beta2 agonist (LABA), vilanterol "VI" (FF/VI 100/25 mcg). Following this approval by the FDA, it is anticipated that BREO ELLIPTA will be available in the US during the third quarter of 2013. Under the terms of the 2002 LABA collaboration agreement, Theravance is obligated to make a milestone payment of $30 million (USD) to GSK following FDA approval of BREO ELLIPTA. The data submitted to the FDA to support the regulatory review of FF/VI included data from a comprehensive programme of non-clinical studies, 52 clinical pharmacology studies in 1,406 patients, and 11 clinical studies in 7,851 patients with COPD. There were four primary COPD studies: two 6-month lung-function studies and two 1-year replicate exacerbation studies.