Clinical Intelligence

uniQure initiates phase I study in acute intermittent porphyria

Wednesday, December 12, 2012 10:48 AM

uniQure, a company that researches and develops human gene based therapies, has initiated its phase I clinical trial in acute intermittent porphyria (AIP).

More... »

NanoString touts positive results from study of PAM50-based breast cancer assay

Friday, December 7, 2012 03:01 PM

NanoString Technologies, a Seattle, Wash.-based privately held provider of life science tools for translational research and developer of molecular diagnostic products, released positive results from the second clinical validation study of its in vitro diagnostic breast cancer assay based on the PAM50 gene expression signature.

More... »

FDA grants Biodel orphan drug designation for rare insulin disease

Friday, December 7, 2012 02:34 PM

The FDA has given special designation to glucagon, developed by specialty pharmaceutical company Biodel,for patients with congenital hyperinsulinism (CHI), or abnormally low blood sugar—a rare disorder that affects children.

More... »

Emmaus Medical completes enrollment for phase III sickle cell disease trial

Wednesday, December 5, 2012 10:11 AM

Emmaus Medical, a specialty pharmaceutical and regenerative medicine company, has completed patient enrollment for its phase III clinical trial to study L-glutamine as a treatment for sickle cell disease.

More... »

AVEO, Astellas initiate phase II trial in triple negative breast cancer

Monday, December 3, 2012 02:11 PM

AVEO Oncology, a Cambridge, Mass.-based cancer therapeutics company, and Astellas Pharma, A Tokyo-based a pharmaceutical company, have initiated patient enrollment in a phase II trial evaluating the efficacy of tivozanib, an investigational drug, in combination with paclitaxel in patients with locally recurrent or metastatic triple negative breast cancer.

More... »

The CenterWatch Monthly, December 2012

Monday, December 3, 2012 09:00 AM

Publicity, regulation tightening reins on use of KOLs

More... »

Boston Scientific enrolls first patient in coronary stent study featuring bioabsorbable polymer coating

Friday, November 30, 2012 12:13 PM

The first patient has been enrolled in Boston Scientific’s EVOLVE II clinical trial, designed to further assess the safety and effectiveness of the SYNERGY Stent System and support FDA and Japanese regulatory approvals for the treatment of atherosclerotic coronary lesions.  

More... »

Common canine virus may lead to new vaccines for deadly human diseases

Friday, November 30, 2012 11:21 AM

Researchers at the University of Georgia have discovered that a virus commonly found in dogs may serve as the foundation for the next great breakthrough in human vaccine development.

More... »

FDA approves Cometriq to treat rare type of thyroid cancer

Thursday, November 29, 2012 08:00 AM

The FDA has approved Cometriq (cabozantinib) to treat medullary thyroid cancer that has spread to other parts of the body.

More... »

Almirall’s Constella approved in Europe for IBS-C

Wednesday, November 28, 2012 12:20 PM

The European Commission has granted marketing authorization to Almirall’s Constella (linaclotide 290mcg) for the symptomatic treatment of moderate to severe Irritable Bowel Syndrome with Constipation (IBS-C) in adults . This approval follows the positive recommendation received from the European Committee for Medicinal Products for Human Use (CHMP) in September.

More... »