SOURCE: The Bedford Report

The Bedford Report

March 04, 2011 08:46 ET

Drug Approval Process May Be Faster but It's Also Stricter

The Bedford Report Provides Analyst Research on Pfizer & Avanir Pharmaceuticals

NEW YORK, NY--(Marketwire - March 4, 2011) -  There is plenty of optimism surrounding the healthcare sector as firmer pricing and new products have improved sales and earnings trends. Meanwhile, younger, more speculative firms continue to garner significant attention with potential blockbuster products working their way through the regulatory process. The Bedford Report examines the outlook for companies in the Healthcare Sector and provides research reports on Pfizer, Inc. (NYSE: PFE) and Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR). Access to the full company reports can be found at:

A recent study released by BIO and BioMedTracker claims that the success rate in bringing new medicines to market in the past six years is only about half of what it had been previously. The study claims, however that biotech drugs are twice more likely to gain approval than more traditional chemical drugs.

The study finds that drugs moving from early stage Phase I clinical trials to FDA approval is roughly ten percent, down from around 20 percent in reports involving earlier years.The report adds that approval applications were filed for 55 percent of the drugs that made it to Phase III testing, and 80 percent of those gained eventual approval -- though only half were approved on initial review.

The Bedford Report releases regular market updates on the Healthcare Sector so investors can stay ahead of the crowd and make the best investment decisions to maximize their returns. Take a few minutes to register with us free at and get exclusive access to our numerous analyst reports and industry newsletters.

Regulatory approval of drugs is a process that frequently comes under fire for being too rapid or too slow. The FDA has reacted to long standing criticism by streamlining some of its guidelines and procedure. Europe's EMEA has largely resisted expediting its approval process. A recent study suggested that the European drug approval system takes twice as long to approve cancer drugs than does the FDA, adding fuel to recent criticism of the European drug approval process.

In recent sector news, industry giant, Pfizer, said Monday it received European Commission approval for the Dupuytren's contracture treatment Xiapex. Pfizer said Xiapex is the first injectable treatment to be approved in the European Union for Dupuytren's contracture, and the drug will be available in some European markets later this year.

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