Topic:

Clinical Trials

Latest Headlines

Latest Headlines

Big Pharmas back Ra's $58.5M bet on a rival to Soliris

Watch out, Alexion. Little Ra Pharmaceuticals in Cambridge, MA, is prepping a clinical study of a new drug that it hopes will one day cut in front of your franchise-building blockbuster Soliris. And the biotech has raised $58.5 million from a lineup of big pharma venture arms and A-list investors to back their clinical bet on a rival to one of the world's most expensive drugs.

Xoma crushed as lead drug flunks a PhIII challenge

After stoking investors' dreams of a turnaround, Xoma delivered another nightmare. The Berkeley, CA-based biotech reported early Wednesday that a Phase III study of gevokizumab in patients with Behçet's disease uveitis was a bust.

Novavax's Ebola vaccine shows promise in PhI

Back in February, Novavax took its Ebola candidate to Australia for a Phase I trial. The company reported positive top-line results from the 230-person trial on Tuesday.

UPDATED: Bristol-Myers flags early success for PhIII Opdivo study in kidney cancer

Bristol-Myers Squibb flagged an early success for its Phase III Opdivo (nivolumab) study for kidney cancer, saying that an independent monitoring group concluded that its closely watched checkpoint inhibitor has beat Afinitor (everolimus) in improving overall survival for advanced patients.

Playing defense, Baxalta makes its case for a new hemophilia drug

Fresh off of completing its spinout from Baxter, Baxalta has unveiled the positive data it's using to back an approval for BAX 855, a long-acting factor VIII-replacement therapy that's designed to do a better job at producing blood clots for hemophilia A patients.

GSK and J&J/Bavarian Nordic take Ebola candidates to Senegal, Europe

Although the waning Ebola outbreak had Big Pharmas struggling to find volunteers for their Ebola vaccine trials, two new Phase II trials are going forward. GlaxoSmithKline will take its candidate to Senegal, while Johnson & Johnson and partner Bavarian Nordic will test their vaccine in France and the U.K.

Roche hustles to FDA with PhII PD-L1 cancer success for 'breakthrough' star atezo

Roche says its closely watched PD-L1 checkpoint inhibitor atezolizumab (MPDL3280A) hit its primary endpoint in a midstage study for bladder cancer, shrinking tumors for a narrowly defined set of patients and setting the stage for early discussions with the FDA about the possibility of an accelerated approval for this "breakthrough" drug.

J&J's IL-23 psoriasis contender scores a PhIIb win in a turbulent race

J&J's IL-23 blocker came through in a Phase IIb psoriasis study, with one of the top doses clearing symptoms of the disease in 86% of patients. Easily beating out the placebo response, the top psoriasis contender--which is facing off against a lineup of competing remedies in late-stage development--also beat out Humira in the study.

NIAID launches PhI trial of investigational West Nile virus vaccine

The mosquito-borne West Nile virus has infected more than 41,000 people and killed more than 1,700 people in the U.S. since 1999. But while there is an effective veterinary vaccine for the virus, there is no commercially available human vaccine. The National Institutes of Health's NIAID is launching a Phase I trial of a human vaccine at Duke University.

J&J's HIV vaccine shows promise in monkeys; PhI/IIa to start soon

The search for an HIV vaccine has been long and difficult, but researchers from Johnson & Johnson, Harvard and other groups may have made a leap. J&J's Janssen reported encouraging results Thursday from its preclinical trial of an HIV vaccine in rhesus monkeys. Encouraging enough for the company to sponsor human studies--the first time a Big Pharma is doing so in the HIV space.