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ImmunoCellular Therapeutics seeks FDA orphan drug status for ICT-107 dendritic-cell based vaccine for GBM

ImmunoCellular Therapeutics announced today it has filed an orphan drug application with the U.S. Food and Drug Administration (FDA) for its cancer treatment candidate ICT-107. ICT-107 is a dendritic-cell based cancer vaccine product which targets glioblastoma multiforme (GBM), the most prevalent, aggressive and malignant form of primary brain tumors.

3 May 2010

RECOTHROM topical hemostat exhibits low rate of anti-product antibody formation

ZymoGenetics, Inc., today announced the publication of pooled safety and immunogenicity observations from eight clinical trials of RECOTHROM in the February issue of the Journal of the American College of Surgeons. The authors concluded that RECOTHROM is a well-tolerated topical hemostatic agent in numerous surgical settings and has a low rate of anti-product antibody formation. In the pooled data from all trials, less than one percent of treated patients developed product-specific antibodies. None of the antibodies neutralized native coagulation proteins.

2 Feb 2010

Sirion Therapeutics sNDA for Durezol to treat uveitis accepted for FDA review

Sirion Therapeutics, Inc. announced today that its supplemental New Drug Application (sNDA) submitted to the U.S. Food and Drug Administration (FDA) seeking market approval of Durezol(TM) (difluprednate ophthalmic emulsion) 0.05% to treat endogenous anterior uveitis has been accepted for review.

16 Mar 2009

FDA approves Lusedra (fospropofol disodium) injection for monitored anesthesia care sedation

Eisai Corporation of North America today announced that the U.S. Food and Drug Administration (FDA) has approved Lusedra (fospropofol disodium) Injection, an intravenous sedative-hypnotic agent for monitored anesthesia care (MAC) sedation in adult patients undergoing diagnostic or therapeutic procedures.

14 Dec 2008

Combined therapeutic approach of stenting and photodynamic therapy improves survival in late stage liver cancer patients

A combined therapeutic approach of stenting and photodynamic therapy may improve survival rates for patients suffering from advanced liver bile duct cancer, according to a study published this month in Clinical Gastroenterology and Hepatology , the official journal of the American Gastroenterological Association (AGA) Institute.

12 Mar 2008