News

• Wed 6/5/13: Endo Health  (ENDP) owers guidance to reflect Opana FDA decision; announces restructuring; co will explore strategic alternatives for its HealthTronics business and branded pharma discovery platform and seek accretive acquisitions (ENDP) 35.96 -0.50 : Co updates FY13 guidance to reflect Opana FDA decision to allow generics; co lowers EPS to $4.10-4.30 from $4.40-4.70 vs. $4.28 Capital IQ Consensus; lowers FY13 (Dec) rev to $2.65-2.80 bln from $2.80-2.95 bln vs. $2.8 bln Capital IQ Consensus. 
• Wed 6/5/13:  Celgene( CELG) : FDA approves REVLIMID (lenalidomide) for the treatment of patients with relapsed or refractory mantle cell lymphoma (CELG) 112.43 -5.34 : Co announced the U.S. Food and Drug Administration (FDA) has approved the company's supplemental new drug application (sNDA) for REVLIMID (lenalidomide) for the treatment of patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib. The approval was based on the results of MCL-001, a phase II, multi-center, single arm, open label study evaluating lenalidomide in 134 patients with MCL who had received prior treatment with rituximab, cyclophosphamide, an anthracycline (or mitoxantrone), and bortezomib alone or in combination.
• Wed 6/5/13: Vertex Pharma (VRTX) announces presentation of data at European Cystic Fibrosis Society Conference (VRTX) 77.66 -0.71 : Co announced that six abstracts from its cystic fibrosis (CF) program will be presented at the 36th European Cystic Fibrosis Society (ECFS) Conference in Lisbon, Portugal, June 12 to 15, 2013. Presentations include data from Cohorts 2 and 3 of a Phase 2 study of lumacaftor (VX-809) combined with ivacaftor in people with the most common mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene, F508del, as well as data from a Phase 2 study of VX-661 combined with ivacaftor in people with two copies of the F508del mutation. Additionally, poster presentations will feature data on the use of KALYDECO (ivacaftor) in people with CF ages 6 and older who have the G551D mutation.
• Wed 6/5/13: Vivus (VVUS) files definitive proxy materials with SEC; urges stockholders to vote 'for' the Board's nominees on gold proxy card (VVUS) 14.12 -0.48 : Co announced that it has filed its definitive proxy materials in connection with the Company's 2013 Annual Meeting of Stockholders, to be held on July 15, 2013, with the SEC. The VIVUS Board of Directors unanimously recommends that stockholders vote "FOR" all of the Company's directors on the GOLD proxy card. Letter stated: "VIVUS's Board of Directors and management team have been consistent in their strategy to ensure commercial success for Qsymia. We are making significant progress in laying the foundation for Qsymia by expanding patient access, gaining payor reimbursement and creating awareness with physicians. Recent important milestone events have already increased stockholder value and we believe will increase sales in the near future....Throughout 2013 we expect to continue to expand both access and reimbursement for Qsymia. We have a clear strategy and plan for increasing patient and physician adoption. The Board and management team are critical to continued progress in the future. A wholesale turnover in the Board or management will put at risk the continued successful implementation of this plan...."