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News Breaks
March 6, 2014
05:30 EDTNVSNovartis announces Xolair approved in EU
Novartis announced that the European Commission has approved the use of Xolair, omalizumab, as an add-on therapy for the treatment of chronic spontaneous urticarial, or CSU, in adult and adolescent patients with inadequate response to H1-antihistamine treatment. The approved dose is 300 mg by subcutaneous injection every four weeks. The EU approval follows the Committee for Medicinal Products for Human Use positive opinion on Xolair, which was adopted based on positive and consistent results from three pivotal Phase III registration studies that involved nearly 1,000 patients with CSU not responding to H1-antihistamines. Xolair 300 mg met all primary and pre- specified secondary endpoints across these studies, which showed Xolair significantly improved itch and hives, including rapid itch relief, and in many cases completely cleared symptoms. Quality of life was also significantly improved for patients treated with Xolair 300 mg across the Phase III study program.
News For NVS From The Last 14 Days
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May 22, 2015
10:52 EDTNVSJPMorgan says Actavis shares cheap compared to peers
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May 21, 2015
08:39 EDTNVSNovartis initiates Phase 1 PCA062, triggering milestone payment to ImmunoGen
In a regulatory filing, ImmunoGen disclosed Novartis (NVS) Institutes for BioMedical Research notified ImmunoGen (IMGN) that Novartis had initiated Phase I, first-in-human clinical testing of a product candidate, PCA062, utilizing antibody-drug conjugate technology. Pursuant to the license taken under our 2010 Multi-Target Agreement, this start of clinical testing triggers a $5M milestone payment to ImmunoGen.
05:19 EDTNVSNovartis Afinitor extended PFS in Phase III trial in GI or lung origin NET
Novartis announced that the Phase III study of Afinitor tablets plus best supportive care in patients with advanced nonfunctional neuroendocrine tumors, or NET, of gastrointestinal, or GI, or lung origin met its primary endpoint: significant extension of progression-free survival, or PFS, compared to placebo plus best supportive care. The RADIANT-4 study is part of one of the largest clinical trial programs in NET.
May 20, 2015
11:36 EDTNVSNovartis says COPD programs met endpoints in Phase III study
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May 19, 2015
08:57 EDTNVSLeerink biotech analyst holds an analyst/industry conference call
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06:55 EDTNVSGenocea could be takeover target after data, says Piper Jaffray
Piper Jaffray analyst Edward Tenthoff expects Genocea Biosciences (GNCA) will report positive Phase II GEN-003 post-immunization results late in Q2. GEN-003 is a therapeutic vaccine for genital herpes targeting Herpes Simplex Virus Type 2. Positive GEN-003 data could position Genocea as a potential acquisition target by a larger vaccine player, Tenthoff tells investors today in a research note. Large vaccine makers include Sanofi (SNY), Merck (MRK), GlaxoSmithKline (GSK), Pfizer (PFE) and Novartis (NVS). The analyst reiterates an Overweight rating on Genocea with a $14 price target. Shares of the clinical-stage vaccine developer with a $227M market capitalization closed yesterday up 83c to $10.22.
May 18, 2015
12:29 EDTNVSCorium announces publication of data for needle-free transdermal flu vaccine
Corium International announced the publication of "promising" data on the use of its needle-free transdermal system to deliver influenza vaccine in the June 9 issue of Vaccine. The manuscript, entitled "Fabrication of cell culture-derived influenza vaccine dissolvable microstructures and evaluation of immunogenicity in guinea pigs," details results of a preclinical study conducted by Novartis Vaccines (NVS) and Corium. The results demonstrate the compatibility of Corium's MicroCor needle-free transdermal system with cell culture-derived influenza vaccines, and establish its potential as a next-generation vaccine delivery system, the company said.
07:38 EDTNVSNovartis outlook has improved, says Bernstein
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May 15, 2015
09:31 EDTNVSAmerican Thoracic Society to hold a conference
ATS 2015 Conference is being held in Denver on May 15-20.

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