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News For FLDM;OVSC;STEM;PFE;PSTI;LH;CYTX;LLY;NBS;ATHX;ACTC From The Last 14 Days
Check below for free stories on FLDM;OVSC;STEM;PFE;PSTI;LH;CYTX;LLY;NBS;ATHX;ACTC the last two weeks.
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September 16, 2014
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.
05:49 EDTPSTIPluristem Therapeutics pursues development strategy in Japan
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September 15, 2014
09:25 EDTPFEJPMorgan biotech analysts hold an analyst/industry conference call
Analysts assess Pfizer's M&A options on an Analyst/Industry conference call to be held on September 15 at 10 am.
07:27 EDTPFE, PSTI, ATHXIBC Life Sciences to hold a conference
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07:27 EDTPFEPfizer acquisition could drive shares higher, says JPMorgan
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07:26 EDTLLYPiper Jaffray to hold a conference
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07:21 EDTLHHeart Failure Society of America to hold annual meeting
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September 14, 2014
13:32 EDTPFEPfizer shares look cheap, Barron's says
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September 12, 2014
10:32 EDTPFEPfizer CEO says company still open to inversion deal, FT says
Pfizer (PFE) CEO Ian Read said U.S. rhetoric against tax inversions has been "political theater" ahead of midterm elections and made clear that his company is still open to a potential tax-saving acquisition, according to Financial Times, which added Read's comment about not being “held hostage” over price would likely be read as a signal the company might look elsewhere after being rebuffed by AstraZeneca (AZN). The Fly notes that Bloomberg previously reported, citing people familiar with the matter, that Pfizer is looking at targets other than AstraZeneca, including Actavis (ACT). Shares of Actavis trading in New York are up 2% this morning. Reference Link
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
07:32 EDTNBSNeoStem licenses patent portfolio from Rockefeller University
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September 10, 2014
12:14 EDTACTCSEC announces fraud charges against Advanced Cell Tech, former CEO
The Securities and Exchange Commission has charged a Massachusetts-based biotech company and its former CEO with defrauding investors by failing to report his sales of company stock.The federal securities laws require certain corporate executives to report their transactions in the company’s stock in order to give investors the opportunity to evaluate whether the purchases and sales by an insider could be indicative of the prospects of the company. An SEC investigation found that after Gary H. Rabin became CEO, CFO, and chairman of Advanced Cell Technology in 2010, he repeatedly failed to report his sales of company stock for the next few years. Subsequently, ACT’s annual reports and proxy statements during that period were inaccurate because they failed to report that Rabin was not complying with his obligation to disclose his substantial sales of ACT stock. ACT and Rabin agreed to settle the SEC’s charges.
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
08:36 EDTLHARCA Biopharma, LabCorp announce GENETIC-AF poster presentation
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07:18 EDTNBSRodman & Renshaw to hold a conference
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07:15 EDTPFE, LLYIBC 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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05:43 EDTPSTIPluristem Therapeutics advances to second cohort in PLX-PAD cells Phase I trial
Pluristem Therapeutics announced that its licensee, United Therapeutics Corporation, has completed the dosing of the first cohort of patients in its Phase I study using Pluristem's PLacental eXpanded, or PLX-PAD, cells in patients diagnosed with pulmonary arterial hypertension, or PAH. PAH, with a global market estimated at approximately $3B, is characterized by abnormally high blood pressure in the arteries of the lungs; it can disrupt lung and heart function, leading to debilitating conditions such as heart failure. The Phase I study, being conducted in Australia, is an open-label, dose-escalation study designed to enroll 9 patients diagnosed with PAH. The first cohort of 3 patients has received 0.5M PLX cells per kilogram body weight. An independent Data Safety Monitoring Board recommended advancement to the second cohort. The second cohort will receive 1M cells per kilogram, while the third cohort is planned to be administered 2M cells per kilogram. The primary endpoint of the study is the safety of PLX-PAD cells, which will be evaluated at 12 weeks and one year after dosing. Secondary efficacy endpoints are to be measured at six weeks post-treatment in order to assess changes in the ability to exercise, disease severity and cardio-respiratory function; measures include six-minute walk distance and cardio-pulmonary hemodynamic parameters evaluated via right heart catheterization and echocardiogram.
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