Topic:

Clinical Trials

Latest Headlines

Latest Headlines

Genocea's genital herpes vaccine succeeds in PhII

There is no cure for genital herpes, but Genocea is getting closer to marketing an immunotherapy that could control herpes symptoms. The Massachusetts-based company announced Wednesday that it met its goals in a Phase II study of its investigational GEN-003 vaccine.

Genocea's herpes vaccine hits the mark in Phase II

Genocea Biosciences' in-development vaccine for genital herpes met its goals in a Phase II trial, sending the biotech's shares soaring.

Racing a crowded field, Amgen says migraine drug looks promising in PhII

Amgen says it got the positive data it was looking for from a Phase II study of AMG 334, one of several experimental migraine drugs that share the same target and are in the running to compete against an old generation of drugs on the market.

Bavarian Nordic smallpox vaccine scores two late-stage trial wins

The threat of a smallpox outbreak is an ongoing concern that's helped Bavarian Nordic pay its bills through the years. With an announcement Wednesday trumpeting two successful late-stage tests, the company has reason to believe it can advance its business with smallpox vaccine Imvamune.

Sage steps up to a pivotal PhIII as brain seizure drug aces trial challenge

Sage Therapeutics has successfully wrapped a small Phase I/II study of its lead drug for rare brain seizures, coming out with a 77% response rate among evaluable patients that was a slight step up from its interim results last fall. That successful end to the study puts the biotech on the threshold of a pivotal study with a clear shot at a new drug approval that would thrust it into the commercial world.

AstraZeneca partner Ardelyx dives (again) as lead drug flunks PhII

Shares of Ardelyx plunged in after-market trading Tuesday after the AstraZeneca partner conceded failure in a Phase IIa study of its troubled lead drug.

UPDATED: A gene therapy 'cure' for blindness starts to fade within a few years

Gene therapies command avid attention due to their promise of providing a cure for some terrible conditions along with the prospect of a 7-figure price tag. But some prominent investigators at the University of Pennsylvania reported that their "cure" for blindness only worked for one to three years before patients' vision began to fade again. And their decline could rattle some of the hot biotechs in the group.

UPDATED: GSK's shingles candidate more effective than Merck's Zostavax in older adults, study says

Zostavax is the only shingles vaccine approved in the U.S. and the EU, but GlaxoSmithKline is one step closer to changing that. On Tuesday, the British pharma announced Phase III results for its shingles candidate, HZ/su, reporting an overall efficacy of 97.2% compared with placebo.

Aerie shares crushed after glaucoma therapy flops in PhIII

Two months ago Aerie Pharmaceuticals CEO Vicente Anido was boasting to Reuters that his late-stage therapy for glaucoma, Rhopressa, was on track to an approval with a clear shot at earning $1 billion a year. On Thursday evening, he was forced to mount a defense of the drug after conceding defeat in a key Phase III study and watching shares plunge 66% in a rout.

Amgen, AstraZeneca prep a brodalumab pitch--after scuttling asthma program

Amgen and its partner AstraZeneca are winding up to deliver U.S. and European applications for their big blockbuster hopeful brodalumab for plaque psoriasis by midyear. But their last shot to push ahead with the drug in asthma ran into defeat, with Amgen announcing Tuesday afternoon that it pulled the plug on a Phase IIb following a futility assessment.