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News Breaks | | | | December 3, 2012 | | 11:37 EDT |  | LH, CYTX, LLY, NBS, ATHX, ACTC, FLDM, OVSC, STEM, PFE, PSTI | Genetics Policy Institute to host a summit
World Stem Cell Summit is being held in West Palm Beach, Florida on December 3-5 with webcasted presentations to begin on December 3 at 8 am. Webcast Link | |
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News For LLY;PFE;ACTC;CYTX;STEM;ATHX;LH;OVSC;NBS;PSTI;FLDM From The Last 14 Days Check below for free stories on LLY;PFE;ACTC;CYTX;STEM;ATHX;LH;OVSC;NBS;PSTI;FLDM the last two weeks. |
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| May 10, 2013 | | 08:08 EDT |  | PFE | Pain Therapeutics discloses Pfizer reassessing continued Remoxy partnership
Pain Therapeutics (PTIE) disclosed a letter its CEO was sent from partner Pfizer (PFE) in which the drug maker said it is reassessing its endorsement of the Remoxy program "given the years of delay, additional cost incurred to bring the program to this point and development work left in the program." Pfizer said it will be reaching out to Pain Therapeutics "shortly" to have a confidential discussion about the terms of the companies' contractual agreement over the pain drug. Pfizer that it appears there is a regulatory pathway forward for Remoxy, but that the company does not expect to respond to submit a Complete Response letter for Remoxy to the FDA before mid-2015. Pfizer added in its letter to Pain Therapeutics "no final decision has been made at this time" on how it will proceed with the Remoxy development program. Shares of Pain Therapeutics fell 47% to $2.81 in pre-market trading following the disclosure of the correspondence. | | | 08:02 EDT | | LLY | Eli Lilly's Enzastaurin Phase III study did not meet primary endpoint
Eli Lilly announced Phase III clinical trial results from enzastaurin's PRELUDE study, which explored the molecule as a monotherapy in the prevention of relapse in patients with diffuse large B-cell lymphoma. The study failed to show a statistically significant increase compared to placebo in disease-free survival in patients at high risk of relapse following rituximab-based chemotherapy. There were no new safety findings, and the safety data were consistent with previously disclosed studies. Lilly will stop development of enzastaurin, which is expected to result in a second-quarter charge to R&D expense of approximately $30M. The company's previously-issued financial guidance for 2013 remains unchanged. | | | 07:46 EDT | | PFE | DURECT says additional clinical studies needed for Remoxy
DURECT (DRRX) announced that Pfizer (PFE) has provided an update on Remoxy in a regulatory filing. Pfizer's disclosure included: "We have been working to address the issues raised in the letter, which primarily relate to manufacturing. We met with the FDA in March 2013 to discuss our plan to address the June 2011 "complete response" letter. We received written guidance from the FDA in May regarding required next steps, including additional clinical studies, to address the letter. Based on this guidance, we are considering our options with respect to Remoxy. If we elect to continue development of Remoxy, we would not expect to submit a response to the 'complete response' letter before mid-2015." DURECT said it understands from Pfizer that additional clinical studies are necessary and include, in part, a pivotal bioequivalence study with the modified formulation to bridge to the clinical data conducted with the original formulation, as well as an abuse potential study with the modified Remoxy formulation. Remoxy is based on DURECT's ORADUR technology. Shares of Pfizer's Remoxy partner Pain Therapeutics (PTIE) are down 56% in pre-market trading, while shares of DURECT are down 13%, or 20c, to $1.39. | | | May 9, 2013 | | 16:46 EDT |  | NBS | NeoStem reports Q1 EPS (5c), two estimates (5c)
 Subscribe for More Information | | | 16:28 EDT | | STEM | StemCells reports Q1 EPS (17c), consensus (13c)
Reports Q1 revenue $284,000, consensus $290,000. | | | 16:07 EDT | | CYTX | Cytori Therapeutics reports Q1 EPS (11c), consensus (15c)
Subscribe for More Information | | | 11:01 EDT | | LLY | Sears Holdings names Jeff Balagna Chief Information Officer
Subscribe for More Information | | | 10:17 EDT |  | PFE | Shire trades higher in London amid takeover chatter, Guardian says
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