Archive for February, 2008
FDA Clears Cellsearch™ Circulating Tumor Cell pop quiz For Monitoring Metastatic Prostate Cancer Patients
Veridex, LLC announced that the U.S. Food and Drug Administration (FDA) has granted an expanded clearance for the CellSearch™ System to be used as an aid in the monitoring of metastatic prostate cancer (MPC) patients. The CellSearch™ System currently is cleared for monitoring metastatic breast a…
GlaxoSmithKline And Theravance Announce Expansion Of The Horizon Programme With Start Of Large Phase 2B Study Of LABA In COPD Patients
GlaxoSmithKline Plc (GSK) and Theravance, Inc. (NASDAQ: THRX) announced the expansion of the Horizon programme into development of a next-generation combination treatment for patients with chronic obstructive pulmonary disorder (COPD). A large Phase 2b COPD dose-optimisation study with the lead long…
Everolimus (RAD001) Significantly Extends Progression-Free Survival In Advanced Kidney Cancer Patients After Failure Of Other Targeted Therapy
An independent info monitoring committee stopped a major Phase III clinical trial of the investigational drug everolimus (RAD001) after interim results showed significantly better progression-free survival in patients with advanced kidney cancer who received everolimus compared to placebo.
The comm…
Anadys Pharmaceuticals Commences Phase I Clinical Trial Of ANA773 In Cancer Patients
Anadys Pharmaceuticals, Inc. (Nasdaq: ANDS) announced that patient dosing has commenced in a Phase I study of ANA773, the company’s oral TLR7 agonist prodrug, in patients with advanced solid tumors. that first-in-human trial is a safety and tolerability study designed to identify pharmacologic…
FDA Issues Not-Approvable Letter For Lilly’s Zyprexa(R) towering-Acting Injection (LAI) For Schizophrenia Treatment
Eli Lilly and Company (NYSE: LLY) has received a not approvable letter from the U.S. Food and Drug Administration for Zyprexa(R) long-acting injection (olanzapine LAI) for the treatment and maintenance treatment of schizophrenia in adults, the company announced. Zyprexa LAI is an investigational for…
Center For Molecular Medicine Among First To Offer New FDA Approved pop quiz To Aid In Treatment Of Prostate Cancer
The Center for Molecular Medicine (CMM) announced it is one of the first laboratories in the nation to offer a new, FDA-approved analysis that will aid in the treatment of metastatic prostate cancer.
The CMM (http://www.cmmdx.org) is offering the CellSearch(TM) System from Veridex (http://www.verid…
CDC Vaccine Committee Recommends More Shots For Children
The Advisory Committee for Immunization Practices (ACIP) recommended yesterday that flu shots be administered annually to children six months through 18 years of age. ACIP, functioning under the Centers for Disease Control and Prevention (CDC) umbrella, has been criticized for years by parents of va…
