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News Breaks | | | | November 16, 2012 | | 07:46 EDT |  | NVS | Novartis receives positive CHMP opinion for Bexsero
Novartis announced that the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency, or EMA, has adopted a positive opinion for Bexsero (Meningococcal Group B Vaccine [rDNA, component, adsorbed]) for use in individuals from 2 months of age and older. Upon regulatory approval, Bexsero will be the first licensed broad coverage vaccine that can help protect all age groups against MenB disease, including infants, the age group at the greatest risk of infection. The European Commission generally follows the recommendations of the CHMP and delivers its final decision within three months, which will be applicable to all European Union, or EU, and European Economic Area, or EEA, countries. Upon approval, each member state will evaluate Bexsero reimbursement schemes and determine the potential inclusion of the vaccine into National Immunization Programs. Novartis is committed to making Bexsero available as soon as possible and is already engaging with governments interested in the early adoption of the vaccine. | |
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News For NVS From The Last 14 Days Check below for free stories on NVS the last two weeks. |
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| May 20, 2013 | | 07:29 EDT |  | NVS | Deutsche Bank to host a conference
dbAccess Asia Conference 2013 is being held in Singapore on May 20-22. | | | May 17, 2013 | | 16:20 EDT | | NVS | Novartis drug Afinitor extended time without disease progression in women
 Subscribe for More Information | | | May 16, 2013 | | 08:11 EDT | | NVS | Novartis says no intention of pursuing Actavis, Bloomberg reports
Subscribe for More Information | | | May 15, 2013 | | 19:37 EDT |  | NVS | Novartis weighing Actavis bid, WSJ reports
Subscribe for More Information | | | 18:17 EDT | | NVS | Novartis weighs possible bid for Actavis, DJ reports
Subscribe for More Information | | | May 10, 2013 | | 05:42 EDT | | NVS | Novartis drug Ilaris approved by FDA
Subscribe for More Information | | | May 6, 2013 | | 16:23 EDT | | NVS | Array to start first company-led Phase 3 trial with MEK162
Array (ARRY) announced the planned start of its first company-led Phase 3 trial with MEK162 in low-grade serous ovarian cancer. This is the third MEK162 pivotal trial that is expected to initiate in 2013 and one of five pivotal trials Array expects to begin in 2013 on Array-invented products. Novartis (NVS), who is co-developing MEK162 with Array, previously stated that Phase 3 trials in NRAS-mutant melanoma and BRAF-mutant melanoma are expected to start this year and AstraZeneca has announced its plans to initiate two registration trials with selumetinib, a MEK inhibitor invente (AZN) d by Array, in KRAS-mutant non-small cell lung cancer and in thyroid cancer. Array also recently released initial data on its wholly-owned hematology drug, ARRY-520, from a combination trial with VelcadeŽ (bortezomib) in patients with relapsed or refractory multiple myeloma (MM), showing that the drug was generally well-tolerated and showed initial signs of activity in this heavily pretreated population. | |
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