Tag Archive: vaccines

Feb 15 2013

Everything You Need to Know About Priority Review Vouchers: Part 2 of 2

The Rare Pediatric Disease PRV, the Difference in the PRVs, and the Future of the Program The Rare Pediatric Disease Priority Review Voucher (If you haven’t read Part 1 yet, start there first!) A new Priority Review Voucher (PRV) has been introduced that could be a game changer with respect to the program.  Nancy Goodman …

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Jun 06 2012

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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Feb 20 2012

New FDA Guidances – December 2011/January 2012

Here’s a list of the notable guidances released by FDA in December 2011 and January 2012, compiled by Cato Research Regulatory Scientist Cathy Anderson. December 2011 FDA Portable Document Format (PDF) Specifications (Updated) (More info on this guidance can be found in this previous blog post) The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications …

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Mar 14 2011

2010 New Drug Approvals

The U.S. FDA’s Center for Drug Evaluation and Research (CDER) approved 21 new products in 2010 – slightly less than the previous year’s 24 – plus 5 biologics approved by CBER. In light of the FDA’s continued focus on drug safety, I am not surprised that the number isn’t higher. A full list of approvals can be found here.

While the list isn’t long, a few new products stand out to me.

Mar 03 2011

Google Insights – A Tool for Smarter Clinical Site Selection

Influenza Like Illness Percentage

Every year, epidemics of the seasonal flu cause major health concerns and numerous deaths around the world.  Vaccines are made in massive quantities and extra precautions are taken, such as hand washing of children in schools, in an effort to reduce the spread and scope of flu outbreaks.  However, these precautions are often not enough …

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Feb 17 2011

New Book – Principles of Anticancer Drug Development

Recently, Humana Press/Springer published a new book, Principles of Anticancer Drug Development. Neil Clendeninn M.D., Ph.D., a Senior Clinical Research Physician for Cato Research, served as an editor for the book, which has been described as a practical guide to the design, conduction, analysis and reporting of clinical trials with anticancer drugs.

Oct 25 2010

FDA Pediatric Study Information

The FDA’s Pediatric Drug Development page is a great place to find information on pediatric studies.  FDA just posted the most recent metrics for studies performed between September 27, 2007 and September 30, 2010 related to the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA).  During that period, 305 studies including …

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Jun 29 2010

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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Mar 18 2010

Challenges associated with oncology development within an immunotherapeutic platform

Although cancer immunotherapeutics (intended to treat already existing cancers by strengthening the body’s natural defenses) represent a very active area of development world wide, few cancer immunotherapeutics have been approved to date. Unfortunately, the overall clinical benefit in patients treated with an immunotherapeutic (intended for oncology indication, or otherwise) compared with those treated with placebo …

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