United States

The Hamner Institutes for Health Sciences partners with QPS Holdings

Wednesday, February 20, 2013 10:26 AM

The Hamner Institutes for Health Sciences, a nonprofit research organization focused on translational safety sciences, and QPS Holdings, a Newark, Delaware-based CRO, have announced the launch of QPS Hepatic Biosciences, a center of excellence for cell based research and services. 

More... »

Sanford Heisler files $100m+ class action complaint against Daiichi Sankyo

Wednesday, February 13, 2013 10:32 AM

Six current and former female pharmaceutical sales professionals have filed a $100 million class and collective action gender discrimination lawsuit against Daiichi Sankyo, the U.S. branch of the Japan-based pharmaceutical company, in the U.S. District Court for the Northern District of California.

More... »

K&L Consulting Services selects OpenClinica Enterprise clinical trial software

Wednesday, February 13, 2013 09:34 AM

K&L Consulting Services, a CRO based in Fort Washington, Penn., has selected the OpenClinica Enterprise Edition for Electronic Data Capture (ED”) and clinical data management for phase I-IV clinical trials. K&L is increasing the breadth of its capabilities in the U.S. as well as in Asia and the Pacific region, especially in China.

More... »

Court shuts down U.S. operations of Titan Medical Enterprises

Monday, February 11, 2013 02:56 PM

A federal judge has ordered Titan Medical Enterprises, a Santa Fe Springs, Calif.-based manufacturer, and its owner, James L. McDaniel, to stop manufacturing and distributing drugs and dietary supplements in domestic commerce until their manufacturing operations comply with the Federal Food, Drug, and Cosmetic Act.

More... »

FDA offers new guidance on developing drugs for Alzheimer's

Friday, February 8, 2013 11:47 AM

The FDA has issued a proposal designed to assist companies developing new treatments for patients in the early stages of Alzheimer's disease, before the onset of noticeable dementia.

More... »

GVB BIO licenses biomarker database to FDA

Thursday, February 7, 2013 08:00 AM

GVK Biosciences, a discovery, research and development organization providing a broad spectrum of services, is extending its Clinical Biomarker Database (GOBIOM) license to the Biomarker Qualification Group of the FDA. The GOBIOM database, which has the latest and recently updated information on all the biomarkers reported in various clinical and preclinical studies, will be beneficial to the FDA in its Biomarker Qualification Process.

More... »

Janssen Labs at San Diego adds concept lab, open collaboration space

Wednesday, February 6, 2013 10:43 AM

Janssen Labs at San Diego, part of Janssen Research & Development, is adding a concept lab and an open collaboration space, just one year after opening.

More... »

Idenix Pharmaceuticals cancels IDX184 and IDX19368 programs for HCV

Wednesday, February 6, 2013 09:45 AM

Idenix Pharmaceuticals, a Cambridge, Mass.-based biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, has elected not to continue its clinical development program for IDX184, a nucleotide polymerase inhibitor in phase IIb testing for the treatment of hepatitis C virus (HCV) infection, or to continue its development of IDX19368, an HCV nucleotide polymerase inhibitor for which the company had previously filed an IND but had not initiated patient dosing.

More... »

Almac’s new U.S. commercial packaging operations pass FDA inspection

Wednesday, February 6, 2013 09:16 AM

Global service provider Almac has passed FDA inspection of its new U.S. commercial packaging operations located in Audubon, Penn. The inspection took place on Jan. 9 and 10, 2013, from which the regulatory body concluded that the site is fully compliant with Good Manufacturing Practices, with no 483 issued.

More... »

Gilead touts positive results in two phase III studies of sofosbuvir for Hep C

Monday, February 4, 2013 02:14 PM

Gilead Sciences, a biopharmaceutical company based in Foster City, Calif., released top line results from two phase III studies, FISSION and NEUTRINO, evaluating a 12-week course of the once-daily nucleotide sofosbuvir in combination with ribavirin (FISSION) and in combination with ribavirin and pegylated interferon (NEUTRINO) among treatment-naïve patients with chronic hepatitis C virus (HCV) infection.

More... »