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Clinical Intelligence

Evotec receives preclinical milestone payment from Boehringer Ingelheim

Monday, October 14, 2013 09:30 AM

Evotec’s research alliance with Boehringer Ingelheim has reached a milestone in September triggering revenues of $5.4 million to Evotec. The milestone was for the transition of an oncology molecule into pre-clinical development.

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CRF Health eCOA webinar series

Ampio Pharmaceuticals announces positive results from Optina trial

Tuesday, October 8, 2013 09:00 AM

Ampio Pharmaceuticals, a development stage biopharmaceutical company, has announced interim results from the ongoing 450 patient, dose finding, 505(b)(2) study of Optina as a treatment for Diabetic Macular Edema (DME). This interim analysis was conducted by an Independent Data Review Committee (IDRC) comprised of a statistician and an ophthalmologist/retinologist, who were permitted to view the unmasked data from the trial. At least 30% of patients had reached the first four-week time point and their clinical results were considered representative data for the trial.

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Cardiome publishes positive data from atrial fibrillation study

Tuesday, October 8, 2013 08:30 AM

Cardiome Pharma has published positive data from an observational, retrospective study performed at the Skane University Hospital in Malmö, Sweden. The study included 251 recent-onset atrial fibrillation (AF) patients who received 355 BRINAVESS treatments between Jan. 15, 2011 and April 15, 2013. During the observation period, 70% of the AF patients treated with BRINAVESS converted with a median time of 11 minutes.

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GSK pays Isis $7 million for ISIS-GSK3Rx milestones

Tuesday, October 8, 2013 07:00 AM

GlaxoSmithKline (GSK) has added development candidate ISIS-GSK3Rx to its collaboration with Isis Pharmaceuticals. Isis earned $7 million in milestone payments associated with the advancement of this program. ISIS-GSK3Rx is an antisense drug designed to inhibit the production of an undisclosed target to treat a common viral infection. Isis will develop ISIS-GSK3Rx to phase II proof-of-concept, after which GSK has an exclusive option to in-license the program and further develop and commercialize the asset.

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Merck to continue development of Tecemotide in phase III trial

Tuesday, October 1, 2013 10:30 AM

Merck Serono, the biopharmaceutical division of Merck, has decided to continue clinical development of the investigational MUC1 antigen-specific cancer immunotherapy tecemotide  (also known as L-BLP25 and formerly known as Stimuvax). Merck Serono, which is developing tecemotide under a license agreement with Oncothyreon, will conduct a new phase III trial called START2 for patients with unresectable, locally advanced stage III non-small cell lung cancer (NSCLC).

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Caris Life Sciences study reports positive results for evidence-guided tumor profiling

Tuesday, October 1, 2013 10:00 AM

Caris Life Sciences, a biosciences company focused on personalized medicine, has announced data from two studies which demonstrate the potential of evidence-guided tumor profiling to immediately improve the treatment of patients with hard-to-treat cancers, including cancers of unknown primary (CUP) and rarer and refractory cancers.

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The CenterWatch Monthly, October 2013

Tuesday, October 1, 2013 09:00 AM

New growth and decline in Asia clinical trials

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X-Chem achieves milestones, licenses drug discovery programs to AstraZeneca

Wednesday, September 25, 2013 02:43 PM

X-Chem, a privately-held biotechnology company focused on applying its drug discovery capabilities to the generation of novel small molecule therapeutics, has achieved several milestones leading to the licensing of three drug discovery programs by AstraZeneca, in the context of a collaboration the companies established in May 2012.

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KaloBios publishes KB001 phase I study results

Monday, September 23, 2013 01:33 PM

KaloBios Pharmaceuticals has published phase I study results for KB001, a first-generation, anti-Pseudomonas aeruginosa (Pa) type III secretion system (TTSS) antibody for use in patients with cystic fibrosis (CF). Data from this initial single-dose clinical study support the continuation of KaloBios' ongoing phase II study of KB001-A, a second-generation, anti-TTSS antibody in CF patients with chronic Pa infections.

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NIH awards $33m grant to Banner Alzheimer's Institute, study planned

Friday, September 20, 2013 11:14 AM

Banner Alzheimer's Institute (BAI) has announced a major prevention trial to evaluate a treatment in cognitively healthy older adults at the highest known genetic risk for developing Alzheimer's disease at older ages. An NIH grant, expected to total $33.2 million, will support this research.

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April 14

Proposal calls for back-to-back trials to measure efficacy and effectiveness prior to FDA approval

Study: Minority populations under-represented in cancer trials, but have higher rates of incidence

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The CenterWatch Monthly

April

Make way for mobile health in clinical trials
Despite patient retention, data quality benefits, regulatory hurdles persist

Global clinical trial laboratories decentralize
Regional labs reducing complexity, delivering cost and time savings

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March

Strategic alliances hit bumps in the road
Mixed relationship performance driving new approaches

Tapping community hospitals for clinical trial volunteers
New study finds high potential but infrastructure, resources are lacking

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