ADVENTRX Pharmaceuticals and Cell Therapeutics Look Promising as Fourth Quarter Kicks Off
October 04 2011 - 8:16AM
Marketwired
In recent years the FDA has been heavily scrutinized for making the
approval process more difficult for drug developers. A ground
breaking study released this year by the BIO and BioMedTracker
finds that the overall success rate for drugs moving through
clinical trials to FDA approval from late 2003 to the end of 2010
is a mere ten percent. The Bedford Report examines the outlook for
companies in the Biotechnology Industry and provides equity
research on Cell Therapeutics, Inc. (NASDAQ: CTIC) and ADVENTRX
Pharmaceuticals, Inc. (AMEX: ANX). Access to the full company
reports can be found at:
www.bedfordreport.com/CTIC
www.bedfordreport.com/ANX
Previously the rate of approval was one in five to one in six.
Oncology drugs faced the toughest road to approval despite the fact
that the disease area is the most closely studied in all of drug
development.
Janet Woodcock, the head of the FDA's drug division, is quick to
dismiss concerns regarding the FDA's approval process. This summer
in testimony before the House Energy and Commerce's health
subcommittee, Woodcock explained the agency meets more than 90% of
deadlines that are part of the drug-review process. She also said
so-called first cycle approvals are at a 20-year high with and said
more than two-thirds of new drugs being approved within the
six-to-10-month time frames given to new drug applications.
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Last Friday ADVENTRX Pharmaceuticals announced that it held a
Type A meeting with the U.S. Food and Drug Administration (FDA) to
discuss the complete response letter (CRL) it received in August
from the FDA regarding the Company's New Drug Application (NDA) for
Exelbine (vinorelbine injectable emulsion) for the treatment of
non-small cell lung cancer.
Last week shares of Cell Therapeutics jumped after the company
said a second independent radiology assessment of data from a
clinical trial of its antitumor treatment pixantrone confirmed the
statistical robustness of the data.
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