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News Breaks
May 14, 2014
07:32 EDTMYL, LLYMylan launches generic Zyprexa Zydis tabletsEli Lilly
Mylan (MYL) has launched Olanzapine Orally Disintegrating Tablets 5 mg, 10 mg, 15 mg and 20 mg, the generic version of Eli Lilly's (LLY) Zyprexa Zydis Tablets. Mylan received final approval from the FDA for its Abbreviated New Drug Application for this product, which is indicated for the treatment of schizophrenia or the acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. Olanzapine ODT, 5 mg, 10 mg, 15 mg and 20 mg, had U.S. sales of approximately $120.8M for the 12 months ending March 31, 2014.
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September 18, 2014
15:55 EDTLLYFDA approves Eli Lilly type 2 diabetes drug
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11:15 EDTLLYRepros sinks after panel backs tests for testosterone therapies
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08:12 EDTLLYEli Lilly's Cyramza for gastric cancer shows positive Phase 3 results
Eli Lilly announced results of the global Phase III trial of ramucirumab - CYRAMZA - in combination with paclitaxel in patients with advanced gastric cancer or gastroesophageal junction adenocarcinoma. The addition of ramucirumab to paclitaxel showed a statistically significant improvement in median overall survival, meeting its primary endpoint; it also met secondary endpoints of progression-free survival and objective response rate. Data from the trial were first presented in January. Ramucirumab has now been the focus of two positive Phase III gastric cancer trials that have demonstrated statistically significant improvements in both overall survival and progression-free survival.
08:01 EDTLLYDow AgroSciences announces R&D agreement with Lilly's Elanco
Two Indiana agricultural companies, Elanco, the animal health division of Eli Lilly and Company (LLY), and Dow AgroSciences LLC, a wholly owned subsidiary of The Dow Chemical Company (DOW), are announcing a strategic research and development agreement that will focus on developing integrated solutions to enable livestock producers to increase meat and milk production to meet the demands of the growing global population.
06:10 EDTLLYFDA panel votes 20-1 to study changes to testosterone therapies
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September 17, 2014
11:01 EDTMYLActavis drops after NY AG seeks to block Alzheimer drug switch
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07:39 EDTLLYMorningstar to hold a conference
Management Behind the Moat Conference to be held in Chicago on September 17-18.
September 16, 2014
12:35 EDTLLYDenovo Biopharma acquires late-stage oncology drug enzastaurin from Eli Lilly
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11:51 EDTMYLOECD looks to close tax loopholes with new proposals
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07:33 EDTMYLMylan 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 EDTLLYEuropean 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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06:34 EDTMYLMylan signs agreement with Gilead
Mylan (MYL) announced that its subsidiary Mylan Laboratories Limited has entered into an agreement with Gilead Sciences (GILD), under which Mylan has been licensed the non-exclusive rights to manufacture and distribute sofosbuvir and the investigational single tablet regimen of ledipasvir/sofosbuvir in 91 developing countries. Sofosbuvir is marketed by Gilead under the brand name Sovaldi. The countries within the agreement account for more than 100M people living with hepatitis C globally representing 54% of the total global infected population. Under the licensing agreement, Mylan will receive a technology transfer enabling the company to manufacture low-cost versions of the medicines for developing markets.
September 12, 2014
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 10, 2014
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.
07:02 EDTMYLMylan to acquire U.S. rights to Arixtra injection from Aspen
Mylan's subsidiary Mylan Ireland Limited has entered into an agreement to acquire the U.S. commercialization, marketing and intellectual property rights relating to Arixtra Injection and the authorized generic of Arixtra from Aspen Global Incorporated. Arixtra is indicated for the prophylaxis of deep vein thrombosis, which may lead to pulmonary embolism in patients undergoing hip fracture surgery. Mylan already is selling Arixtra in the U.S. through an interim distribution arrangement with Aspen and Apotex is currently selling the AG of Arixtra, which will be transitioning to Mylan Institutional by year end.
September 9, 2014
06:42 EDTMYLLew expects to make decision on combating inversion deals soon, NY Times reports
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