Topic:

Clinical Trials

Latest Headlines

Latest Headlines

Vietnam taps Quintiles to up its stake in global trials

The Vietnamese government is looking to boost its share of the world's clinical research market, signing a deal with CRO giant Quintiles to get the ball rolling.

Oncolytics tanks on 'confounding' PhIII for cancer drug

Canada's Oncolytics Biotech trumpeted some promising late-stage results for its viral head and neck cancer therapy, but a distortion in the company's overall survival data rattled investors, sending its shares down as much as 8.6% on Thursday.

PhI data puts Novartis on track to deliver H7N9 vaccine

The trial found two doses of the adjuvanted cell culture vaccine immunologically protected 85% of participants.

Daiichi's a-fib drug aces PhIII, faces crowded market

Daiichi Sankyo's atrial fibrillation-treating edoxaban posted promising results in Phase III, matching the stroke-prevention prowess of warfarin with a better safety profile, but the drug may struggle to carve out market share in a cluttered space.

Anthera's castaway cardio drug increased heart attack risk, long-delayed study says

Last year, Anthera Pharmaceuticals pulled the plug on its lead drug after the cardiovascular disease treatment ran into some insurmountable efficacy problems in Phase III but failed to mention that the now-discarded varespladib actually increased patients' risks of heart attack and stroke. The study's lead investigator said Anthera dragged its feet in releasing the data.

Amgen's cancer-fighting virus boosts melanoma survival in PhIII study

In the latest trove of promising Phase III data for Amgen's T-Vec, the cancer-fighting virus increased overall survival by four months compared to standard growth factor therapy, driving optimism that the drug can win approval and make some noise in the melanoma market.

Merck spotlights promising data on 'breakthrough' cancer immunotherapy MK-3475

Merck highlighted evidence of a rising response rate to its closely watched immunotherapy MK-3475, spotlighting an 81% overall survival rate for advanced melanoma patients after 12 months of therapy with 41% of all patients demonstrating tumor shrinkage--rising to an impressive 51% for one group at the high end of the dose range.

AbbVie steps closer to FDA filing as first hep C PhIII delivers promising results

With Gilead's pioneering hepatitis C drug sofosbuvir moving closer to a likely approval and a megablockbuster market, AbbVie is looming from behind with some promising results from the first of 6 Phase III studies of its breakthrough triple-threat therapy. 

Zafgen obesity drug scores heavyweight success in PhII trial

Promising results from early-stage work on Zafgen's weight drug beloranib clear a path to a Phase IIb trial that can fine-tune the dose while taking more time to gauge the long-term impact of its treatment on weight and set the right tone for ongoing talks with investors about a new financing round for the biotech.

Novavax presents positive Phase I data for H7N9 vaccine

The reemergence of H7N9 in China during the past month has reinforced the need for a vaccine. Candidates from Chinese and Taiwanese manufacturers have grabbed the headlines recently, but now a U.S. player, Novavax, has joined the race with positive Phase I data.