Ardea’s oral MEK inhibitor shows favorable anti-tumor activity
In mouse xenograft studies, when MEK inhibitor (RDEA119) was dosed orally once daily for 14 days, it caused significant inhibition and delay of tumor growth. Inhibition of pERK

In mouse xenograft studies, when MEK inhibitor (RDEA119) was dosed orally once daily for 14 days, it caused significant inhibition and delay of tumor growth. Inhibition of pERK

The FDA has requested certain non-clinical information, including additional in vitro dissolution data, as a condition to final approval. The FDA has not requested additional human studies or

This patent includes composition of matter, pharmaceutical composition, method of treatment, and synthetic method claims directed to heat shock protein 90 (Hsp90) inhibitor and other hydroquinone-containing ansamycin analogues.

High-dose intravenous infusions (IV) of so-called ‘first generation’ antisense compounds, known as phosphorothioates, have been associated with severe toxicity in monkey studies. As a consequence, clinical use of

Targacept plans to advance TC-5214, one of two enantiomers of mecamylamine hydrochloride, into clinical development as an augmentation therapy for patients who are inadequate responders to first-line antidepressant

Administered as a single agent, SNS-595 demonstrated anti-tumor activity, with 88% (15 of 17) of evaluable patients having best responses of stable disease or better, including two partial

The amendments are due to preliminary results from pharmacokinetic analyses, including patients and healthy volunteers, indicating that a dose adjustment may be appropriate for certain subpopulations. These protocol

Patients with chronic insomnia can have a higher frequency of work-related problems including absenteeism, an increased rate of accidents, difficulty performing duties and less job satisfaction. The study

The agency will complete its review of the application and may approve or disapprove the application, request additional data or take other administrative actions. The supplemental new drug

Objective responses were reported for two patients, and stable disease was observed in 22 patients. The trail was the first reported human study of an antibody to trail