07:00 , Sep 5, 2016 |  BioCentury  |  Strategy

Back to School: Haste, not waste

As researchers in industry and academia rapidly unravel molecular disease mechanisms and drug developers become more adept at intervening in disease pathways with drugs targeted to specific populations, the current clinical development paradigm cannot keep...
07:00 , Oct 26, 2015 |  BC Week In Review  |  Company News

Cel-Sci, Aptiv Solutions, Ergomed deal

Cel-Sci and Ergomed amended an April 2013 deal and Ergomed will increase to $12 million from $10 million its contribution to the ongoing Phase III trial of Cel-Sci’s Multikine in patients with advanced primary head...
08:00 , Nov 10, 2014 |  BC Week In Review  |  Company News

Theranostics Health management update

Theranostics Health Inc. , Rockville, Md.   Business: Diagnostic, Supply/Service   Hired: Luis Gutierrez as president, CEO and a director, formerly EVP and chief commercial officer of Aptiv Solutions , which ICON plc acquired; he...
07:00 , Aug 4, 2014 |  BC Week In Review  |  Company News

Aptiv Solutions, Eli Lilly, J&J, Novartis, Pfizer, Roche other news

Pfizer and Roche joined the ADDPLAN DF consortium, which is seeking to develop new statistical methods for the design of dose-finding trials. The consortium will hold a public meeting on Aug. 4 to discuss its...
01:12 , Aug 2, 2014 |  BC Extra  |  Politics & Policy

Pfizer and Roche join ADDPLAN DF consortium

Pfizer Inc. (NYSE:PFE) and Roche (SIX:ROG; OTCQX:RHHBY) joined the ADDPLAN DF consortium, which is seeking to develop new statistical methods for designing dose-finding trials. Aptiv Solutions (Reston, Va.), Eli Lilly and Co. (NYSE:LLY), Johnson &...
07:00 , May 19, 2014 |  BC Week In Review  |  Company News

Aptiv Solutions, ICON deal

ICON completed its acquisition of fellow CRO Aptiv Solutions for $143.5 million in cash (see BioCentury, April 7). Aptiv Solutions , Reston, Va.   ICON plc (NASDAQ:ICLR), Dublin, Ireland   Business: Supply/Service  ...
07:00 , Apr 7, 2014 |  BC Week In Review  |  Company News

Aptiv Solutions, ICON deal

ICON will acquire fellow CRO Aptiv Solutions for $143.5 million in cash. Aptiv Solutions designs and executes adaptive clinical trials for pharmaceutical and biotech customers. ICON said that the acquisition differentiates and enhances its services...
08:00 , Feb 24, 2014 |  BioCentury  |  Product Development

Dosing certainty

Novartis AG has developed a new dosing model for Phase II trials that eliminates much of the guesswork around dose selection for Phase III. EMA has endorsed the model and the pharma is in discussions...
08:00 , Jan 20, 2014 |  BC Week In Review  |  Company News

Aptiv Solutions, EMA, U.S. Food and Drug Administration deal

U.S. Food and Drug Administration (FDA) purchased a license to Aptiv's ADDPLAN DF software for analysis of dose-finding study results submitted as part of approval applications to the agency's Center for Drug Evaluation and Research...
08:00 , Nov 11, 2013 |  BC Week In Review  |  Company News

Cel-Sci, inVentiv Health cancer, infectious news

Cel-Sci initiated an arbitration claim against inVentiv's CRO, inVentiv Health Clinical, which Cel-Sci hired to conduct a Phase III trial of the company's Multikine as a first-line treatment of advanced squamous cell carcinoma of the...