FDA's New "Breakthrough" Designation Allows New Drugs to Gain Approval After Just 1 Round of Testing
Five Star Equities Provides Stock Research on Inovio Pharmaceuticals and Omeros
(firmenpresse) - NEW YORK, NY -- (Marketwire) -- 03/27/13 -- Programs developed by the U.S. Food and Drug Administration to speed up the approval process have been a major driver for growth within the Biotech Industry. In 2012, FDA drug approvals totaled a 15-year high of 39, over the past decade drug approvals have averaged roughly 23 a year, according to a recent Bloomberg article. Five Star Equities examines the outlook for companies in the Biotechnology Industry and provides equity research on Inovio Pharmaceuticals Inc. (NYSE: INO) and Omeros Corporation (NASDAQ: OMER).
Access to the full company reports can be found at:
The FDA's new "breakthrough" product designation allows new drugs to win approval after just a single round of testing, instead of the usual three. A total of three promising experimental medicines have been assigned the new status so far, while an additional 18 drugs have applied. The new designation follows three other programs -- Fast Track, Priority Review and Accelerated Approval -- each of which were designed to help bring crucial new drugs to market in a shorter amount of time.
"A breakthrough drug is one that may offer important new benefits for patients with serious or life-threatening disease who are especially in need of new safe and effective treatments," said Janet Woodcock, director of FDA's Center for Drug Evaluation and Research.
Five Star Equities releases regular market updates on the Biotechnology Industry 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 stock reports and industry newsletters.
Inovio's synthetic vaccine technology platform is applicable to cancers and infectious diseases. To date the company has developed vaccine product candidates for cervical dysplasia/cancer, prostate cancer, hepatitis C virus, HIV, influenza, malaria and tropical diseases. Their lead program in cervical dysplasia is in Phase II.
Omeros most clinically advanced product candidates are derived from their proprietary PharmacoSurgery platform designed to improve clinical outcomes of patients undergoing arthroscopic, ophthalmological, urological and other surgical and medical procedures. The company currently has three PharmacoSurgery programs in clinical development.
Five Star Equities 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. Five Star Equities has not been compensated by any of the above-mentioned companies. We act as an independent research portal and are aware that all investment entails inherent risks. Please view the full disclaimer at:
Themen in dieser Pressemitteilung:
Unternehmensinformation / Kurzprofil:
Datum: 27.03.2013 - 07:20 Uhr
Sprache: Deutsch
News-ID 1210970
Anzahl Zeichen: 0
contact information:
Contact person:
Town:
NEW YORK, NY
Phone:
Kategorie:
Commercial & Investment Banking
Anmerkungen:
Diese Pressemitteilung wurde bisher 154 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"FDA's New "Breakthrough" Designation Allows New Drugs to Gain Approval After Just 1 Round of Testing
"
steht unter der journalistisch-redaktionellen Verantwortung von
Five Star Equities (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
