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News Breaks
April 8, 2014
08:39 EDTTKPYY, LLYTakeda to challenge award of $6B in punitive damages, Lilly ordered to pay $3B
Takeda Pharmaceuticals (TKPYY) announced last night that in the case of Terrence Allen, et al. v. Takeda Pharmaceuticals North America the jury found in favor of the plaintiffs and awarded $1.475M in compensatory damages. The allocation of liability was 75% Takeda and 25% Eli Lilly (LLY). The jury also awarded $6B in punitive damages from Takeda and $3B from co-defendant, Eli Lilly. “Takeda respectfully disagrees with the verdict and we intend to vigorously challenge this outcome through all available legal means, including possible post-trial motions and an appeal. We have empathy for the Allens, but we believe the evidence did not support a finding that ACTOS caused his bladder cancer. We also believe we demonstrated that Takeda acted responsibly with regard to ACTOS,” said Kenneth Greisman, senior vice president, general counsel, Takeda. Reference Link
News For TKPYY;LLY From The Last 14 Days
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September 17, 2014
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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07:31 EDTTKPYY, 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
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
06:49 EDTTKPYYFDA approves weight management drug Contrave
The U.S. Food and Drug Administration yesterday approved Contrave as treatment option for chronic weight management in addition to a reduced-calorie diet and physical activity. The drug is approved for use in adults with a body mass index of 30 or greater or adults with a BMI of 27 or greater who have at least one weight-related condition such as high blood pressure, type 2 diabetes, or high cholesterol. Contrave is a combination of two FDA-approved drugs, naltrexone and bupropion, in an extended-release formulation. The effectiveness of Contrave was evaluated in multiple clinical trials that included approximately 4,500 obese and overweight patients with and without significant weight-related conditions treated for one year. Contrave is distributed by Takeda Pharmaceuticals America (TKPYY) for Orexigen Therapeutics (OREX).
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.
September 8, 2014
17:22 EDTTKPYYOrexigen, Takeda Pharmaceutical in services agreement
Orexigen disclosed in a regulatory filing that in preparation for the potential launch of NB32, Orexigen Therapeutics (OREX) and Takeda Pharmaceutical Company (TKPYY) entered into a Manufacturing Services Agreement, dated September 2, in accordance with the Collaboration Agreement between the company and Takeda, effective as of September 1, 2010, as amended by Amendment Number 1 to Collaboration Agreement effective as of September 26, 2013. Pursuant to the Agreement, among other things, the company will supply to Takeda, and Takeda will, subject to certain exceptions as set forth in the Agreement and Collaboration Agreement, exclusively purchase from the Company, all of Takeda’s requirements of NB32 for commercialization in the United States, Canada and Mexico during the term of the Collaboration Agreement. The Agreement will continue in full force and effect until the expiration or termination of the Collaboration Agreement.
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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September 4, 2014
08:11 EDTLLYEli Lilly's insulin peglispro for diabetes shows positive Phase III results
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