Programs by the FDA Designed to Speed up Approval Process for Critical Drugs a Key Factor in Biotech's Industry Success
Five Star Equities Provides Stock Research on Geron and Threshold Pharmaceuticals,
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 Geron Corporation (NASDAQ: GERN) and Threshold Pharmaceuticals, Inc. (NASDAQ: THLD).
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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.
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Geron is a biopharmaceutical company developing first-in-class therapies for cancer. One of Geron's anti-cancer strategies is to inhibit the activity of telomerase. Telomerase is a rational target for the treatment of cancer, with potentially broad applicability, because most cancers have a high level of telomerase activity and relatively short telomeres compared to normal cells.
Threshold is a biotechnology company focused on the discovery and development of drugs targeting Tumor Hypoxia, the low oxygen condition found in microenvironments of most solid tumors as well as the bone marrows of some hematologic malignancies. This approach offers broad potential to treat a variety of cancers. The company swung to a net income of $28.4 million for the fourth quarter, compared to a net loss of $5.3 million a year ago.
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