Topic:

Clinical Trials

Latest Headlines

Latest Headlines

Receptos' lead drug scores another promising PhII--this time for ulcerative colitis

San Diego-based Receptos is on a roll. After the markets closed on Monday, the biotech spread the word that its mid-stage trial for lead drug RCP1063 hit its primary endpoint for spurring remissions and clinical responses among patients suffering from ulcerative colitis in the trial. And the results quickly spurred a 37% spike in its share price, which follows a similar surge when the same drug hit its marks in a mid-stage trial for multiple sclerosis back in the summer.

UPDATED: Akebia craters as adverse events cloud positive PhIIb anemia data

Procter & Gamble spinoff Akebia Therapeutics rolled out a batch of promising Phase IIb efficacy data for its experimental anemia drug today, but investors who came in early this year to back the biotech's IPO in the belief that it holds the key to a potential blockbuster were dinged with signs of safety issues.

Boehringer, Vitae survive first clinical challenge in a crowded Alzheimer's race

The newly public Vitae reported after the market closed on Thursday that the oral BI1181181/VTP-37948 hit the goal posts on a key biomarker for BACE, or beta secretase, flushing a prime suspect behind the disease without triggering any red safety flags in a pair of Phase I studies among a small group of healthy volunteers.

Novartis racks up a new slate of promising PhIII data for secukinumab

Just days after an FDA advisory group gave its unanimous blessing to Novartis for secukinumab (AIN457) as a new treatment for plaque psoriasis, the pharma giant has produced a new slate of Phase III data backing the IL-17 therapy for ankylosing spondylitis.

Top 10 Phase III disasters of 2014

Welcome to the hall of shame, where blockbuster drug projections go to die. This list includes some drugs that clearly should never have wound up in Phase III to begin with, a few that were steered back to the clinic in a doomed attempt to mine something positive, and a couple of notable exceptions that may have helped advance the field by exploring the outer limits of new drug technology.

Sanofi takes rotavirus vax into Phase III with eye on Indian market

India's rotavirus vaccines market is headed for a shake-up, and Sanofi's angling to get in on the action. It got one step closer this week, with its Indian affiliate commencing Phase III clinical trials for its own investigational vaccine.

Penn-Novartis team 'amazed' at remissions, responses in leukemia CAR-T study

Investigators working on Novartis' personalized CTL019 CAR-T program at the University of Pennsylvania say that 90% of a small group of children suffering from very advanced cases of treatment-resistant acute lymphoblastic leukemia achieved complete remission after being treated in the newly updated trial.

Smith & Nephew hit by setback as PhIII regenerative med study flops

Last spring a prominent analyst suggested that a successful late-stage study for Smith & Nephew's spray-on cell therapy for wound healing could be a catalyst to break up the company a la Abbott and Baxter. But today, the discussion of the much buzzed-about trigger event turned bitter after the company reported that the Phase III trial flopped.

AstraZeneca gets some upbeat asthma data to back would-be IL-5 blockbuster

After acknowledging a midstage setback for its key respiratory drug benralizumab in COPD last month, AstraZeneca's big MedImmune division has come back with positive, though somewhat mixed, Phase IIb data underscoring the effectiveness of knocking down eosinophils--white blood cells--in preventing asthma attacks.

Sanofi bird flu vax prompts immune response in PhII--but only with Novartis adjuvant

As it works to refine its vaccine strategy for the event of an avian flu pandemic, the NIH is trialing Sanofi's H7N9 vaccine at a range of doses and with a variety of adjuvant combinations. And now, it has one that looks promising.