Search Results for biomarkers

Showing 1 – 17

EMA Offers Support for More Research on DIVI Biomarkers By Zachary Brennan - Published 09 November 2017

European Medicines Agency (EMA) Executive Director Guido Rasi this week sent a letter of support to the Safer and Faster Evidence-Based Translation (SAFE-T) Consortium and the Predictive Safety Testing Consortium (PSTC) to encourage further study of ways to monitor for drug-induced vascular injury (DIVI) in early clinical drug development.

Categories: News, Europe, US, EMA, FDA, Clinical, Government affairs, Research and development

Tags: Guido Rasi, DIVI biomarkers

Biomarker Qualification: FDA Explains Process and Opportunities for Engagement By Michael Mezher - Published 19 September 2017

In a set of newly released presentations, officials from the US Food and Drug Administration (FDA) explain changes to the agency's biomarker qualification program and detail early opportunities for biomarker developers to engage with FDA.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Regulatory strategy

Tags: Biomarkers, Biomarker Qualification Program, Critical Path Innovation Meeting, 21st Century Cures

EMA Lays out Plans for Companion Diagnostic Guideline By Michael Mezher - Published 28 July 2017

The European Medicines Agency (EMA) on Friday released a concept paper for public consultation outlining issues it plans to address in an upcoming guideline on the challenges in developing companion diagnostics for personalized medicines.

Categories: News, Europe, EMA, In vitro diagnostics

Tags: Companion Diagnostics, CDx, Precision Medicine, Biomarkers

FDA Offers Biomarker Qualification Case Studies By Zachary Brennan - Published 14 June 2017

As part of an educational series on qualifying biomarkers for use in drug development, the US Food and Drug Administration (FDA) has released two fictitious examples of how biomarkers can improve the drug development process and how FDA works with researchers, pharmaceutical companies and patient advocates to qualify biomarkers.

Categories: News, US, CDER, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy, Research and development

Tags: biomarker qualification, FDA case studies, biomarkers, drug development

Qualification of Drug Development Tools: FDA Updates Process By Zachary Brennan - Published 08 June 2017

Thanks to the 21st Century Cures Act, there will be an updated, multi-stage process for qualifying Drug Development Tools (DDTs), which can include biomarkers, animal models and clinical outcome assessments.

Categories: News, US, CDER, Drugs, Due Diligence, Government affairs, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: DDT, drug development tools, biomarkers, clinical outcome assessments

A First for FDA: Cancer Treatment Approved for Any Solid Tumor with a Specific Biomarker By Zachary Brennan - Published 23 May 2017

The US Food and Drug Administration (FDA) on Tuesday granted accelerated approval to Merck’s Keytruda (pembrolizumab) for patients whose cancers have a specific biomarker.

Categories: News, US, FDA, Biologics and biotechnology, Government affairs, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: Keytruda, Merck, biomarkers, oncology approvals

FDA Unveils Regulatory Science Progress Report By Zachary Brennan - Published 30 March 2017

The report, covering fiscal years 2015 and 2016, notes significant US Food and Drug Administration (FDA) progress in refining non-clinical and clinical tools to better evaluate medical products, advancing manufacturing and quality, and enhancing internal IT tools to support the scientific review of regulatory applications.

Categories: News, US, FDA, Biologics and biotechnology, Drugs

Tags: regulatory science, non-clinical models, biomarkers, continuous manufacturing

Biomarkers Used as Outcomes: FDA Wants to Hear More on Examples By Zachary Brennan - Published 26 September 2016

The US Food and Drug Administration (FDA) is seeking comment from interested stakeholders to determine the utility of a list of examples of biomarkers used as outcomes in the development of FDA-approved new molecular entities and new biologics.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Drugs

Tags: biomarkers, biomarker examples, clinical trial biomarkers, FDA and biomarkers

Total Kidney Volume Qualified as a Biomarker by FDA for ADPKD Trials By Zachary Brennan - Published 15 September 2016

The US Food and Drug Administration (FDA) on Thursday released new guidance providing a qualified context for use for the biomarker total kidney volume (TKV) in studies for the treatment of the common, life-threatening genetic disease known as autosomal dominant polycystic kidney disease (ADPKD).

Categories: News, US, FDA, Clinical, Regulatory intelligence, Regulatory strategy

Tags: ADPKD, biomarkers, FDA qualification of biomarkers

FDA Offers New Guidance on Qualified Biomarker for COPD Trials By Zachary Brennan - Published 14 September 2016

The US Food and Drug Administration (FDA) on Wednesday issued guidance providing details on the qualified context of use (COU) for the biomarker plasma fibrinogen in interventional clinical trials of patients with chronic obstructive pulmonary disease (COPD) at high risk for exacerbations and/or all-cause mortality.

Categories: News, FDA, Clinical, Drugs

Tags: COPD clinical trials, qualified biomarkers

FDA: What's Slowing Progress in Some Disease Areas? By Michael Mezher - Published 17 July 2015

In a post to FDA Voice – the US Food and Drug Administration's blog – recently appointed Deputy Commissioner for Medical Products and Tobacco Robert Califf says progress toward curing some diseases, such as Alzheimer's, is being slowed by a lack of understanding of disease biology.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Drugs, Regulatory strategy, Research and development

Tags: Precision Medicine, Biomarkers, Surrogate Endpoints, HCV, Alzheimer's, Robert Califf

Can Drug Development be Accelerated? FDA Wants Help By Alexander Gaffney, RAC - Published 12 February 2015

The US Food and Drug Administration (FDA) is soliciting input on how it might accelerate the development of certain drug products through the use of new and emerging biomarkers.

Categories: News, US, CDER, Biologics and biotechnology, Clinical, Drugs, In vitro diagnostics, Preclinical

Tags: Biomarkers, Drug Development Tools, DDTs, Drug Development Qualification Program

C-Path Initiative's Work on Personalized Medicine Starts to Get Results By Alexander Gaffney - Published 20 April 2012

Categories: FDA

Tags: Compton, Critical Path Institute, C-Path, Latest News, database, biomarkers

Europe: European Medicines Agency Adopts Two Alzheimers Biomarkers By Ansis Helmanis, RegLink - Published 05 April 2012

Categories: Regulatory Update, Europe, EMA

Tags: Alzheimer's, Alzheimers, PET, biomarkers, guidance, disease

EMA Publishes Pharmacogenetics Guideline for Evaluation of Medicines By Alexander Gaffney - Published 14 February 2012

Categories: EMA

Tags: Pharmacokinetics, Genetics, Pharacogenomics, Latest News, biomarkers, clinical trials

EMA Calls for Guidelines on the Use of Pharmacogenomics in Pharmacovigilance Evaluation By Alexander Gaffney - Published 24 January 2012

Categories: EMA

Tags: Genetics, Pharmavigilance, Pharacogenomics, Effectiveness, Latest News, efficacy, biomarkers, safety, clinical trials, pharmacovigilance, risk

FDA Releases Draft Guidance Document on Use of Histology in Biomarker Qualification Studies By Alexander Gaffney - Published 30 December 2011

Categories: FDA

Tags: Qualification Studies, Histology, Latest News, biomarkers, draft guidance