Biotech Industry Looks to Benefit From FDA's New "Breakthrough" Designation
Five Star Equities Provides Stock Research on Biosante Pharmaceuticals and ZIOPHARM Oncology
NEW YORK, NY -- (Marketwire) -- 03/12/13 -- Programs developed by the U.S. Food and Drug Administration to speed up the approval process has 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 has 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 Biosante Pharmaceuticals Inc. (NASDAQ: BPAX) and ZIOPHARM Oncology Inc. (NASDAQ: ZIOP).
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 www.FiveStarEquities.com and get exclusive access to our numerous stock reports and industry newsletters.
BioSante's products include LibiGel for the treatment of female sexual dysfunction, specifically hypoactive sexual desire disorder, which is in Phase III development. BioSante also is developing a portfolio of cancer vaccines, with 17 Phase I and Phase II clinical trials currently on-going. The company recently announced their independent proxy advisory firm, Glass, Lewis & Co., LLC, has recommended stockholders vote "FOR" the merger with ANI Pharmaceuticals, Inc.
ZIOPHARM Oncology is a biopharmaceutical company focused on the discovery and development of new cancer therapies. The company's portfolio is comprised of five clinical-stage product candidates in all phases of development, as well as multiple research-stage candidates. ZIOPHARM has recently intitiated a Phase 2 clinical study of Ad-RTS IL-12 in combination with palifosfamide for the treatment of advanced breast cancer.
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: www.FiveStarEquities.com/disclaimer