Topic:

Clinical Trials

Latest Headlines

Latest Headlines

Big Pharma supergroup dishes on de-personalizing clinical data

TransCelerate BioPharma, a nonprofit founded by some of the world's biggest drugmakers, is looking to standardize how the industry protects patient privacy when sharing data.

AstraZeneca's self-styled 'blockbuster' benralizumab tanks in severe COPD study

AstraZeneca was forced to concede a clinical defeat on Monday, noting that one of its top respiratory drugs in the clinic failed a study for severe chronic obstructive pulmonary disease. But while investigators also flagged a higher rate of adverse events for benralizumab than the placebo arm, the pharma giant shows no signs of backing away from a treatment it's billed as a potential $2 billion per year product.

PPD looks to tamp down pesky placebos with new trial tech

Countless clinical trials are done in by unexpectedly well-performing placebo arms, a phenomenon particularly common in psychiatric studies. PPD believes a new, proprietary trial design can substantially level the playing field, and the CRO has paid an undisclosed sum to get its hands on the technology.

Edison's orphan drug misses the mark in Phase II

Edison Pharmaceuticals' in-development rare disease treatment missed its primary endpoint in a mid-stage trial, denting the company's plans for an expansive take on CNS R&D.

FDA rushes J&J, NewLink Genetics Ebola vaccines to clinical trials

Another Big Pharma player is joining the hustle toward an Ebola vaccine as the death toll surpasses 1,900 victims, eclipsing the total number of people who died from the disease in all previous outbreaks combined.

Lilly claims another head-to-head victory over Lantus in PhIII diabetes showdown

Eli Lilly took another big step toward filing its long-acting insulin peglispro for an approval, racking up some more positive HbA1c Phase III data in a head-to-head showdown with Sanofi's bestselling Lantus.

Despite a late-stage flop, Kamada preps its orphan drug for EMA review

Israeli biotech Kamada confirmed that its lead candidate failed to meet both its primary and secondary endpoints in a late-stage trial--but that won't interrupt the company's plans to file for European approval.

Sanofi's dengue shot ups serotype 2 protection rate in final trial

Results from Sanofi's dengue vaccine trial are in, and once again, the data confirm its overall efficacy. But notably, this trial also saw an improvement in protection against dengue serotype 2, a viral strain that's tripped up the vaccine in previous studies.

UPDATED: Cabozantinib flops against prostate cancer, forcing big job cuts at Exelixis

Late on Monday evening Exelixis put out the word that its crucial late-stage study of cabozantinib flunked a comparison study with prednisone for castration-resistant prostate cancer, triggering a restructuring that will eliminate 70% of the jobs at the biotech.

Novartis' LCZ696 kindles megablockbuster projections with impressive PhIII heart data

Novartis told the world back in March that its experimental heart drug LCZ696 had delivered the goods early in a pivotal study, allowing for a quick wrap of the Phase III trial. And today the pharma giant painted in the numbers, completing the late-stage picture for a closely watched therapy that has the potential to rival the most successful drug franchises now on the market.