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News Breaks
January 28, 2013
15:53 EDTNVS, TEVA, AGNAppeals court upholds judgment in favor of Allergan in suit with Teva, Sandoz
The U.S. Appeals Court for the Federal Circuit affirmed a lower court ruling that proposed products described in Abbreviated New Drug Applications from Teva Pharmaceuticals (TEVA) and Sandoz, a unit of Novartis (NVS), infringed claim 10 of Allergan's (AGN) ’819 patent for Lumigan. Lumigan is FDA approved to reduce intraocular pressure in people with ocular hypertension or glaucoma. Reference Link
News For AGN;TEVA;NVS From The Last 14 Days
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May 29, 2015
08:32 EDTTEVATeva launches generic Lomedia 24 Fe tablets
Teva announces the launch of the generic equivalent of Lomedia 24 Fe as part of the extensive line of Women’s Health products. The product will be launched under the name Junel Fe 24 and is now available in the United States. Lomedia 24 Fe marketed by Amneal had annual sales of approximately $32M in the United States, according to IMS data as of December 2014. Junel Fe 24 is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.
May 28, 2015
09:07 EDTTEVAFTC, Teva reach $1.2B settlement over Provigil
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08:55 EDTTEVAXenon Pharmaceuticals sees IND for phase 1 trial of XEN801 in mid-2015
Xenon Pharmaceuticals (XENE) announced that Dr. Simon Pimstone, Xenon's President and CEO, will present a business update, including progress toward milestones, at the Jefferies Global Healthcare Conference on Tuesday, June 2. Xenon's partner Teva Pharmaceutical (TEVA) is conducting a randomized, double-blind, placebo-controlled Phase 2b clinical trial for TV-45070 in osteoarthritis. Results from the trial are now expected late in the second quarter or early in the third quarter of 2015. Xenon's partner Genentech, a member of the Roche Group (RHHBY), is currently conducting a Phase 1 clinical trial for GDC-0276, which is expected to complete patient enrollment in the second half of 2015. Xenon expects to file an investigational new drug equivalent application to initiate a Phase 1 clinical trial of XEN801, a stearoyl Co-A desaturase or SCD1 inhibitor for treatment of acne, in mid-2015. If supported by positive data from the Phase 1 trial, Xenon plans to initiate a proof-of-concept Phase 2 clinical trial in the second half of 2015. Xenon expects to file an investigational new drug application for Xenon's Nav1.6 sodium channel inhibitor for Dravet Syndrome in 2016.
06:11 EDTTEVATeva takes 1.35% stake in Mylan, says 'ready to meet' on deal
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May 27, 2015
12:10 EDTTEVATeva to sweeten offer for Mylan before July shareholder vote, NY Post says
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08:32 EDTNVSNovartis entered into collaboration with Rani Therapeutics, Reuters says
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08:24 EDTTEVAFDA reports paragraph IV patent challenge received for Treanda
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07:33 EDTNVSIncyte says clinical portfolio to be featured in 23 abstract presentations
Incyte Corporation (INCY) announced that 23 abstracts detailing studies from its clinical development pipeline, including those conducted by Incyte, Novartis (NVS) and independent investigators, will be presented at the 2015 American Society of Clinical Oncology and European Hematology Association annual meetings. These conferences will take place from May 29th – June 2nd in Chicago, IL and June 11th – 14th in Vienna, Austria. “The abstracts to be presented at ASCO and EHA showcase the depth and breadth of our development pipeline in oncology, as well as the success of our collaboration with Novartis,” stated Rich Levy, MD, Incyte’s Chief Drug Development Officer. “Incyte is committed to translating R&D excellence into new medicines which can improve patients’ lives, and these data, including novel:novel combinations from within our portfolio, provide further evidence of our ongoing progress.”
05:22 EDTNVSNovartis to present data on 21 medicines, 11 investigational compounds at ASCO
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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.
06:08 EDTTEVAPerrigo CEO says would talk with Mylan, but at a higher price, Globes reports
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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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