Topic:

Clinical Trials

Latest Headlines

Latest Headlines

BioClinica partners up for risk-based management

BioClinica has inked a deal with consulting firm Kinapse to help spread the adoption of its risk-based monitoring service, a targeted approach to keeping tabs on trials.

Post-swap Novartis preps cancer drug R&D road show

Two of the cancer drugs Novartis traded for from GSK--Tafinlar and Mekinist--will post combo survival data at ASCO.

Regeneus gets green light to move personalized cancer vaccine into PhI

Australian biotech Regeneus is set to become the latest company to brave moving a personalized cancer vaccine into the clinic. The company picked up clearance from an ethics committee this week, clearing the last remaining obstacle between it and the start of an early-phase study.

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.