Articles by Gary Walsh, PhD - BioPharm International

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Articles by Gary Walsh, PhD

Biopharmaceuticals: Approval Trends in 2008

Ten biopharmaceuticals gained marketing authorization in the US or EU in 2008, although only four were new approvals.
Oct 1, 2009

Ten biopharmaceuticals gained marketing authorization in the US or EU in 2008, although only four were new approvals.

Biopharmaceuticals: Approval Trends in 2007

More than 70% of the products were produced in mammalian cells.
Oct 1, 2008

The year 2007 witnessed the approval of fifteen biopharmaceuticals in the United States and European Union.

Book Review: Biopharmaceutical Products in the US and European Markets 6th edition (2 volumes)

Apr 1, 2008

The book is a useful, comprehensive, and truly an excellent reference source of biopharmaceutical information.

Engineering Biopharmaceuticals

An overall increasing proportion of future product approvals will be engineered in some way, either directly or indirectly.
Nov 1, 2007

An overall increasing proportion of future product approvals will be engineered in some way, either directly or indirectly.

Biopharmecuticals: Approval Trends in 2006

Thirteen biopharmaceuticals gained marketing authorization
Sep 1, 2007

There were notable approvals in nonparenteral delivery systems and biosimiliars in 2006.

Biopharmaceuticals: Approval Trends in 2005

Aug 1, 2006

In 2005, 10 biopharma- ceuticals gained marketing approval in the US or Europe, although only five of them were genuinely new molecular entities.

Biopharmaceuticals: Approvals and Approval Trends in 2004

Twelve biopharmaceuticals gained marketing approval in the US and EU in 2004. Antibody-based products represented the single largest product category.
May 1, 2005

Cancer remains the primary indication (three products), again mirroring recent approval trends.

Modern Antibody-Based Therapeutics

Antibody-mediated therapy is based upon the high binding specificity exhibited by antibodies for the antigen against which they are produced.
Dec 1, 2004

As of late 2004, 26 modern antibody-based therapeutic agents have been approved in the European Union and the US. Some 500 such products are currently in development, ensuring that the number of approved antibody-based products will increase substantially over the coming years.

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