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Stock Market & Financial Investment News

News Breaks
February 10, 2013
18:55 EDTNVO, SNY, LLYNovo Nordisk receives FDA 'Complete Response Letter" for Tresiba and Ryzodeg
Novo Nordisk announced that on 8 February it received a Complete Response Letter from the US Food and Drug Administration, FDA, regarding the New Drug Applications for Tresiba (insulin degludec) and Ryzodeg (insulin degludec/insulin aspart). A complete Response Letter is issued by the FDA, when the agency determines that an application cannot be approved in its current form. Reference Link
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September 17, 2014
06:18 EDTSNYSanofi, MyoKardia announce collaboration
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September 16, 2014
12:35 EDTLLYDenovo Biopharma acquires late-stage oncology drug enzastaurin from Eli Lilly
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07:33 EDTSNYMylan initiates Phase III clinical trials for Advair Diskus and Lantus
Mylan (MYL) announced it is initiating Phase III clinical trials for its generic version of GlaxoSmithKline's (GKS) Advair Diskus and its insulin analog to Sanofi's (SNY) Lantus. In October Mylan will commence a Phase III clinical trial to evaluate the equivalence of its product to Advair Diskus when administered by inhalation in adult asthma patients.
07:31 EDTNVO, LLYEuropean Association for Study of Diabetes to hold annual meeting
50th Annual Meeting of EASD to be held in Vienna, Austria on September 15-19.
07:02 EDTLLYEli Lilly and AstraZeneca to co-develop and commercialize AZD3293
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06:27 EDTLLYAstraZeneca, Eli Lilly to jointly develop, commercialize AZD3293
AstraZeneca (AZN) and Eli Lilly (LLY) announced an agreement to jointly develop and commercialize AZD3293, an oral beta secretase cleaving enzyme inhibitor currently in development as a potential treatment for Alzheimer's disease. AZD3293 has been shown in Phase I studies to significantly and dose-dependently reduce levels of amyloid beta in the cerebro-spinal fluid of Alzheimer's patients and healthy volunteers. AstraZeneca announced earlier in 2014 its plan to move AZD3293 into registration trials. Under the terms of the agreement, Lilly will pay AstraZeneca up to $500M in development and regulatory milestone payments. AstraZeneca expects to receive the first milestone payment of $50M in the 1H15. The companies will share all future costs equally for the development and commercialization of AZD3293, as well as net global revenues post-launch. AstraZeneca and Lilly aim to progress AZD3293 rapidly into a Phase II/III clinical trial in patients with early Alzheimer's disease. Lilly will lead clinical development, working with researchers from AstraZeneca's Innovative Medicines Unit for neuroscience, while AstraZeneca will be responsible for manufacturing. The companies will take joint responsibility for commercialization of AZD3293. The agreement is subject to customary terms and conditions. It will have no impact on AstraZeneca's 2014 Core Earnings per Share.
September 15, 2014
07:26 EDTLLYPiper Jaffray to hold a conference
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September 12, 2014
10:04 EDTSNYSanofi unit granted orphan status for treatment of Gaucher disease
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08:02 EDTLLYEli Lilly announces Cyramza Phase III cancer trial meets primary endpoint
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08:01 EDTLLYEli Lilly announces Cyramza Phase III cancer trial meets primary endpoint
Eli Lilly announced that the RAISE trial, a Phase III study of ramucirumab in combination with chemotherapy in patients with metastatic colorectal cancer, met its primary endpoint of overall survival. The global, randomized, double-blind study compared ramucirumab plus FOLFIRI to placebo plus FOLFIRI as a second-line treatment in patients with mCRC after treatment with bevacizumab, oxaliplatin and a fluoropyrimidine in the first-line setting. RAISE showed a statistically significant improvement in overall survival in patients treated with ramucirumab plus FOLFIRI compared to placebo plus FOLFIRI. The study also showed a statistically significant improvement in progression-free survival in the ramucirumab-plus-FOLFIRI arm compared to the placebo-plus-FOLFIRI arm.
September 11, 2014
17:12 EDTNVONovo Nordisk Saxenda receives positive 14-1 vote in favor of approval from FDA
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07:31 EDTNVOFDA Endocrinologic and Metabolic Drugs Advisory Committee to hold a meeting
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05:27 EDTSNYGenzyme announces positive interim results from Lemtrada extension study
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September 10, 2014
11:06 EDTNVOHigh option volume stocks
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07:09 EDTSNYAmericas Committee for Treatment & Research in MS to hold a meeting
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07:04 EDTLLYEU grants marketing authorization for Eli Lilly's insulin glargine product
The European Commission granted marketing authorization for Eli Lilly and Boehringer Ingelheim's insulin glargine product, indicated to treat diabetes in adults, adolescents and children aged 2 years and above. Lilly/Boehringer Ingelheim's insulin glargine product is the first insulin treatment approved through the European Medicines Agency's biosimilar pathway and the fourth diabetes product approved in the EU from the Lilly-Boehringer Ingelheim alliance. It received a positive recommendation from the Committee for Medicinal Products for Human Use on June 26. The marketing authorisation for the alliance's insulin glargine product is based upon a comprehensive clinical data program. The application included results from pharmacokinetic and pharmacodynamic studies, as well as Phase III studies in patients with type 1 and type 2 diabetes.
September 9, 2014
12:46 EDTNVONovo Nordisk weight loss drug helped people get thinner, Bloomberg reports
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September 8, 2014
14:16 EDTSNYSanofi announces FDA approval of Menactra vaccine
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07:15 EDTLLYIBC Life Sciences to hold a conference
10th Annual Cell Line Development & Engineering Conference to be held in Berkeley, California on September 8-10.
07:01 EDTLLYIgnyta names Robert Wild as Chief Scientific Officer
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