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Sirna Therapeutics has reported interim data from the ongoing Phase I trial
for Sirna-027, an siRNA therapeutic for treatment of age-related macular degeneration
(AMD).
Manhattan Pharmaceuticals has concluded its Phase Ia trial and begun patient
dosing in the Phase Ib trial to evaluate the safety and tolerability of defined
doses of orally administered Oleoyl estrone (OE) in obese adults.
Corcept Therapeutics has initiated its third Phase III clinical trial designed
to evaluate the safety and efficacy of Corlux for the treatment of the psychotic
features of psychotic major depression.
Join FDAnews Wednesday, May 11, for a live, 90-minute audioconference
on "Best Practices in Managing CAPA Systems: How Top Companies Prepare
for the #1 Target of FDA Inspections." Discover what the FDA is really
looking for in your corrective and preventive action systems and the seven "must
have" components of every successful CAPA system. On May 19, FDAnews
also will host an audioconference on "Preparing Successful eCTDs: Compliant
Submissions the First Time, Every Time." Learn how to correctly prepare
your electronic common technical documents to the FDA's expectations.
Seattle Genetics has received a patent issued by the U.S. Patent and Trademark
Office (USPTO) relating to the company's antibody-drug conjugate (ADC) technology.
Abbott has submitted a supplemental new drug application to the FDA for the
approval of a new, more convenient tablet formulation of its protease inhibitor
Kaletra.