January 18, 2019biomarkers

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FDA, EMEA Milestone

Critical Path Win: New Biomarkers

July 10, 2008

History has been made. The FDA and the European Medicines Agency (EMEA) have reviewed biomarkers together and agreed. For the first time. Ever. That’s according to Raymond Woosley, president and CEO of the Critical Path Institute (CPI), an Arizona-based public-private partnership that’s trying to, among other things, get industry (pharma and biotech) and government regulators (FDA, EMEA, and potentially others) to review and agree on new biomarkers for testing drug safety. (You can find a few more details in a ClinPage news brief.) Kidney Focus CPI, through its Predictive Safety Testing Consortium (PSTC), managed to get the two big regulating bodies to review biomarkers for drug-induced kidney injury in animals. Out of the 10 they saw, they liked seven. Woosley was psyched. “This is the first step toward global review of data,” he said. Perhaps even more remarkably, CPI has drug makers working together, too. “It’s also the first time 14…more...

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ClinPhone, Oracle, Pharmanet, Acxiom

News Briefs

April 25, 2007

Geospiza and Pharmaceutical Services Corporation (PSC) announced an alliance to deliver software and services to manufacturers of personalized therapies and vaccines based on genetic markers. Under the terms of the agreement,…more...

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FDA, pharmacovigilance, adaptive trial

News Briefs

April 04, 2007

Genelabs Technologies announces that it had reached an agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for a Phase III clinical trial of Prestara…more...

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Clinical Trials Congress Report

MedImmune’s Efficient Trials

February 15, 2007

We’re diving back into our notes from the Clinical Trials Congress (CTC). That would be a 10,000-word, 53-page monster document. Whew. But every time we take another peek, there is more…more...

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$9M Pediatric Genomics Study

Pfizer Aids Canadian Safety Project

November 30, 2006

A major Canadian research project, led by Bruce Carleton and Michael Hayden, will attempt to improve drug safety for children. The effort today received a major contribution of $500,000 from Pfizer Canada. The Genotype-Specific Approaches to Therapy in Childhood (GATC) receives major funding from a Genome Canada/Genome BC-sponsored research program and is led from two research centers…more...

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Theranostics Deal

Biomarkers: Bruker, HealthLinx

November 22, 2006

In a news release, Bruker Daltonics and Australia’s HealthLinx announced a collaboration to find biomarkers useful for detecting complications in pregnancy. The deal involves Bruker’ ClinProt platform. Greg Rice of HealthLinx and Gongyi Shi of Bruker Daltonics’ Fremont, California, lab discovered the biomarkers as a result of the two companies’ ongoing collaboration. Both will be recognised as…more...

A Model Company

Ingenuity-Aventis Deal

March 14, 2006

Ingenuity Systems today announced that it had expanded the terms of its agreement with Sanofi-Aventis in the U.S. Ingenuity Pathways Analysis (IPA) is a web-delivered software application that enables researchers to model, analyze and understand the complex biological systems at the core of life science research. IPA is deployed in most major pharmaceutical companies, hundreds of biotechnology…more...

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