ADVENTRX Pharmaceuticals and Cell Therapeutics Look Promising as Fourth Quarter Kicks Off
The Bedford Report Provides Equity Research on Cell Therapeutics & ADVENTRX Pharmaceuticals
(firmenpresse) - NEW YORK, NY -- (Marketwire) -- 10/04/11 -- 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:
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.
The Bedford Report provides Market Research focused on equities that offer growth opportunities, value, and strong potential return. We strive to provide the most up-to-date market activities. We constantly create research reports and newsletters for our members. The Bedford Report has not been compensated by any of the above-mentioned publicly traded companies. The Bedford Report is compensated by other third party organizations for advertising services. We act as an independent research portal and are aware that all investment entails inherent risks. Please view the full disclaimer at
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Datum: 04.10.2011 - 06:16 Uhr
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