Tag Archive: cancer

Nov 06

New Guidances from FDA for October 2012

FDA released four notable new guidances in October 2012, with a focus on guidances related to medical devices: Guidance: E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs — Questions and Answers (R1) Guidance: FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Goals Guidance: …

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Jun 06

New FDA Guidances Released in May 2012

Here’s a list of the  guidances released by FDA in April 2012, compiled by Cato Research Scientist Elinore Mercer, Ph.D. Pediatric Information for X-ray Imaging Device Premarket Notifications (Draft) S6(R1) Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals Pathologic Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use as an Endpoint to Support Accelerated Approval (Draft) …

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Jul 18

New Guidances from FDA – June 2011

Guidance

Here’s a list of the guidances released by FDA in June 2011, compiled by Cato Research Regulatory Scientist Cathy Anderson. Q11 Development and Manufacture of Drug Substances (Draft) Applying Human Factors and Usability Engineering to Optimize Medical Device Design (Draft) Clinical Trial Endpoints for the Approval of Non-Small Cell Lung Cancer Drugs and Biologics (Draft) …

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May 27

Bridging the Valley of Death: Bringing New Drugs from the Bench to the Clinic

Bridge

To bring a new medicine to the stage of clinical trial testing requires on the order of $500,000 to one million dollars and then seven to ten years of clinical trials and around $800 million dollars before getting to market.  However, it is doable, and one can point to successful biotechs such as Genentech, Amgen, …

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May 12

Conference Recap – Biomarker World Congress 2011

  Everywhere in the news today, we hear that we are in the era of personalized medicine – where new medicines will be tailor-made for individual patients.  Specifically, personalized medicine is dedicated to the concept hat the right drug is administered to the right patient at the right dose at the right time.  To get …

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Apr 07

Clinical Trials in South Africa 101

South Africa has a mixture of both first and third world diseases and a large number of experienced research sites, making the country an excellent location for clinical trials in many indications. As we are a southern hemisphere country, recruitment for seasonal diseases can be maintained when the seasons change in the northern hemisphere. Trials …

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Mar 25

Recap of the NCCN 16th Annual Conference

The 16th Annual National Comprehensive Cancer Network Conference (NCCN): Clinical Practice Guidelines and Quality Cancer Care, was held on 09-13 March 2011 in Hollywood, FL.  The conference hosted almost 2,000 registrants including oncologists, nurses, pharmacist, and other health care professionals. The general sessions provided updates to the changes in the guidelines for various cancers along …

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Jun 30

Cato at the 12th World Congress on Gastrointestinal Cancer

Cato Research will be attending the European Society for Medical Oncology‘s (ESMO)  12th World Congress on Gastrointestinal Cancer in Barcelona, Spain from 30 June to 03 July 2010.  ESMO is the leading European professional organization representing medical oncologists.  The conference will focus on personalized therapy, multidisciplinary management and unraveling molecular mechanisms related to malignancies affecting …

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Jun 29

Cato at the Cancer Vaccines Meeting

This week, Cato Research is attending the Cancer Vaccines meeting in Cambridge, MA on 29 and 30 June.  The conference is the first meeting dedicated to progressing cancer vaccines to market and will feature 21 of the world’s leading experts in oncology and cancer vaccines.  The cutting-edge agenda addresses the key developmental challenges in order …

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May 20

LIPID MAPS 2010 Annual Meeting

The LIPID Metabolites and Pathway Strategy (MAPS) Annual Meeting was held at UCSD in La Jolla, CA from03-04 May 2010.  LIPID MAPS was created in 2003 as a multidisciplinary effort to identify and quantitate all of the major (and some minor) lipid species in mammalian cells and how they change in response to diseases such …

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