News

AMRI working to get out from under FDA warning

After years of back-and-forth with the FDA, AMRI believes it's close to getting clear of a 2010 warning letter for its Burlington, MA, plant, completing a reinspection and preparing a final report.

Aesica teams with QRxPharma for abuse-deterrence tech

Aesica has struck a deal with Australia's QRxPharma, agreeing to promote the company's abuse-deterrence technology to its clients manufacturing controlled drugs.

CROs large and small get serious about eClinical

For CROs running trials around the globe, amassing loads of data is no sweat, but sharing it with sponsors in disparate countries and keeping it all in line for an eventual regulatory application can be daunting. With that in mind, WuXi PharmaTech, Inflamax Research and CROS NT have all signed deals for eClinical software to manage their trials.

ResearchDx expands to meet contract diagnostics demand

Big Pharma has bought into diagnostic development, and a look at FDA drug approvals over the past year shows that regulators are all aboard for targeted therapies. That makes for a spike in demand for molecular tests, and contract diagnostics developer ResearchDx is upping its capacity to cash in on personalized medicine.

CRO Solutions spins niche services into new biz

Indiana's CRO Solutions is rolling all of its niche offerings into a single subsidiary, a move the company said will help it better compete in a changing market for research services.

AstraZeneca picks Tufts for outsourcing-heavy neuro program

AstraZeneca is casting a wide net across industry and academia for its nearly all outsourced neuroscience unit, now looping in Tufts University's School of Medicine to help develop therapies for ailments like Alzheimer's and Parkinson's.

WuXi, PRA snag ex-Theorem CEO to head China JV

WuXi PharmaTech and PRA believe they have a bright future in China together, and they've picked up the founding CEO of Theorem Clinical Research to lead them there.

Corgenix signs CMO deal with EDP Biotech

Diagnostics outfit Corgenix is upping its stake in the contract manufacturing game, inking a deal with EDP Biotech to produce a colon cancer test.

FDA report casts doubt on Chinese trial data

China has fast become a huge pillar on the global R&D scene, with local CROs like WuXi PharmaTech and ShangPharma cashing in on demand for clinical trials in the country. But, with the FDA chiding a sloppy Chinese trial run by Bristol-Myers Squibb, Pfizer and PPD, regulators and researchers may think twice before accepting data gathered in the country.

AstraZeneca picks Blackfield for cancer drug development

German genomics contractor Blackfield locked up a deal with AstraZeneca, agreeing to provide its computational biology technology to help the drugmaker validate an in-development cancer therapy.

Theorem, Emergo team up for devices and diagnostics

Theorem Clinical Research has inked a deal with Emergo Group, pooling their resources to provide regulatory consultation to makers of medical devices and in vitro diagnostics.

NIH, industry back out of India as trials slow to standstill

Amid mounting pressure to rein in loosely regulated trials, India has clamped down on approving studies, but the resulting slowdown has scared off CROs, sponsors and other researchers, according to a report.

Catalent inks Biota flu deal, shifts delivery biz

Following its marked growth over the past few years, New Jersey's Catalent is consolidating its drug delivery operation and teaming up with a drug developer to push a new influenza treatment forward.

Report: Academia could better use CROs for early research

More and more, academic researchers are turning to CROs to pitch in on early-stage projects, but schools could better optimize how they use contractors, according to a report in Nature.

Lawsuits mount as India pushes trial reforms

For years, India's poor have been recruited into clinical trials with the promise of life-saving treatment, often without proper consent or education on side effects. Now, as the country works to tighten its regulations, more and more families are suing for retribution.

CRO Blue Sky taps new CEO amid growth

After more than doubling its capacity over the past year, Blue Sky BioServices has appointed a new CEO, looking to increase its share of the preclinical research market.

Parexel teams with Rutgers for clinical trials

Parexel has united with the Rutgers New Jersey Medical School in a long-term deal to host clinical trials on campus, giving the school a boost to its clinical research unit.

CROs shift as early-phase demand dries up

While pharma's cost-cutting has long been a boon to CROs that can do R&D on the cheap, a lack of early-stage compounds coming down the pike has put the squeeze on labs that focus on preclinical and Phase I services.

Theorem scouts for M&A with new credit line

CRO Theorem Clinical Research has locked down a new credit line with GE Capital, allowing it to draw funds for future acquisitions and expand its footprint.

MMS teams up with Datatrak for eClinical heft

MMS Holdings, a CRO focused on regulatory submissions, has signed on with Datatrak to use the company's cloud-based data management platform.