part 2
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 more than two-thirds of new drugs being approved within the six-to-10-month time frame given to new drug applications.
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Presently, Geron is running clinical trials using embryonic stem cells. Geron is running Phase I trials to see if the cells can restore nerve function in patients who have suffered severe spinal cord injuries. Three years ago the company granted an exclusive global license to Asia Biotech Corporation for the development of non-prescription dietary food supplements, nutraceuticals and cosmetics containing Geron's small molecule telomerase activating compounds.
Nektar Therapeutics (Nektar) is a clinical-stage biopharmaceutical company developing a pipeline of drug candidates that utilize its PEGylation and polymer conjugate technology platforms. The Company's product pipeline consists of drug candidates across a range of therapeutic areas, including oncology, pain.
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