Topic:

Clinical Trials

Latest Headlines

Latest Headlines

Lexicon rockets up after a positive PhIII study sets up an NDA

Shares of Lexicon Pharmaceuticals soared 35% this morning after The Woodlands, TX-based biotech claimed a win in Phase III for one of its lead drugs. The biotech said that telotristat etiprate proved effective against rare cases of carcinoid syndrome, a condition triggered by neuroendocrine tumor cells that causes severe diarrhea.

Synergy Pharma jumps as second PhIII scores a success against constipation

Synergy Pharmaceuticals handed over a fresh set of Phase III data from its second pivotal study of plecanatide, confirming the first round of positive efficacy results for chronic constipation and delivering a slightly improved safety profile that should help as the biotech makes a run at a drug approval and market launch.

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.