FDA Accepts Tasimelteon New Drug Application For Priority Review In The Treatment Of Non-24-Hour Disorder In The Totally Blind

Vanda Pharmaceuticals Inc. (VANDA) (VNDA) today announced that the U.S. Food and Drug Administration (FDA) has accepted the filing and granted a priority review classification to Vanda's New Drug Application (NDA) for tasimelteon, a circadian regulator for the treatment of Non-24-Hour Disorder (Non-24) in the totally blind.

The FDA grants priority review status for a "drug that treats a serious condition and, if approved, would provide a significant improvement in safety or effectiveness" over current therapies^[1].  Currently, there is no approved treatment for Non-24 and tasimelteon has the potential to address this unmet medical need.

Stereotaxis Receives FDA Clearance of Vdrive(TM) with V-Sono(TM) System

Strengthens Niobe(R) Adoption and Opens Growing ICE Catheter Market to Company

Stereotaxis, Inc. (STXS) announced today that it has been granted 510(k) clearance by the Food and Drug Administration (FDA) to market its Vdrive(TM) Robotic Navigation System with V-Sono(TM) Intracardiac Echocardiography (ICE) catheter manipulator in the U.S. This represents the first FDA clearance for the Vdrive family of products, which has been utilized in Europe since 2011.

Prana Doses First Patient in PBT2 Alzheimer's Extension Study

Prana Biotechnology (NASDAQ: PRAN) (ASX: PBT) today announced that the first patient has been dosed in the 12-month open-label extension study with Alzheimer's Disease patients participating in Prana's Phase 2 IMAGINE trial.

Patients who have completed the full 12-month term of the IMAGINE trial are eligible for participation in the open-label Extension study. All participants in the Extension study will receive a 250mg once daily oral dose of PBT2 for an additional 12 months.

The IMAGINE trial is a 12-month double-blind Phase 2 clinical trial of PBT2 in mild or prodromal Alzheimer's patients. The Extension study does not alter the completion and reporting on the IMAGINE trial with results expected in March 2014.

Synta Announces ENCHANT-1 Breast Cancer Results Support Transition to Second Stage of Trial

– Trial evaluating ganetespib monotherapy in HER2-positive and triple-negative breast cancer meets preplanned expansion criteria –
– Complete clinical response and surgical restaging in TNBC patient following treatment with single-agent ganetespib --

Synta Pharmaceuticals Corp. (SNTA) announced today that preliminary results from the ENCHANT-1 clinical trial, which evaluates ganetespib monotherapy in patients with newly diagnosed locally advanced or metastatic HER2 positive or triple-negative breast cancer (TNBC), achieved the prespecified criteria for advancing to the second stage of the trial.