Topic:

Clinical Trials

Latest Headlines

Latest Headlines

Celldex glioblastoma vaccine extends survival in Phase II

In a Phase II trial, Celldex Therapeutics' cancer vaccine rindopepimut, or Rintega, helped recurrent glioblastoma patients who took it with Roche's Avastin survive a median of 3.2 months longer than patients who took Avastin alone. 

AstraZeneca's PhIII gout data for lesinurad includes a hit, a strikeout and a missing player

AstraZeneca has detailed the data from two of three studies of its late-stage combination program for lesinurad, a new drug for gout obtained in their $1.26 billion buyout of Ardea, which showed that the treatment hit the desired biomarker for blood levels of uric acid as promised--but added today that it failed to actually reduce the rate of painful flare-ups of the disease for patients in the study.

Bristol-Myers adds to impressive Opdivo survival data with PhIII melanoma results

Bristol-Myers Squibb has pulled the covers off of impressive Phase III data on Opdivo (nivolumab), pointing to a 73% survival rate among advanced melanoma patients after one year of therapy compared to 42% for the long-used chemo drug dacarbazine.

Study: Myriad skin cancer Dx shows reduction in indeterminate diagnoses

Myriad Genetics said results from a study of its myPath Melanoma test showed a 43% reduction in indeterminate diagnoses of skin cancer and nearly a 50% change by doctors in their treatment recommendations for patients.

Amgen, AstraZeneca's psoriasis drug beats blockbuster Stelara in head-to-head

Amgen and its Big Pharma partner AstraZeneca have roped in another round of promising Phase III plaque psoriasis data for their IL-17 blockbuster contender brodalumab, which beat Johnson & Johnson's big earner Stelara in a head-to-head study.

Threshold shares surge as PhIII cancer program enters FDA's fast track

Shares of Threshold Pharmaceuticals jumped about 10% this morning on news that the FDA is granting fast-track status to TH-302, the company's sole therapy now in a pair of late-stage cancer studies.

Promising asthma trial prompts Regeneron, Sanofi to push dupilumab into PhIII

Regeneron and its close partner Sanofi have cleared the final mid-stage hurdle for dupilumab in asthma patients, with several doses hitting the trial endpoint both for a subset of patients as well as the broad population. And the ambitious development team at Regeneron now plans to hustle into a pivotal late-stage program as they continue to make swift progress with a drug that promises to tackle a trio of conditions that share a core inflammatory trigger.

Battered ArQule shares bump up on badly needed positive data for tivantinib

ArQule's badly battered shares managed a quick surge this morning on news that the biotech's lead drug tivantinib scored a positive outcome in a Phase II metastatic prostate cancer study.

UPDATED: Biotech upstart Sage sees early efficacy for rare brain seizure drug

Sage Therapeutics has successfully resolved a rare seizure disorder among the majority of patients in its small but closely watched Phase I/II study, adding more promising outcomes to the early evidence that helped inspire one of this year's most successful biotech IPOs. In the data update out Monday morning investigators say the 73% overall response rate in their study is also being mirrored among a small group of patients who are receiving the drug on an emergency-use basis.

UPDATED: Merck's hepatitis C cocktail drug fails a 4-week challenge

After sending out signals that it might be running into trouble with a short-duration study of a new triple combination drug for its hepatitis C regimen, Merck investigators hailed the clear success of an 8-week test but confirmed analysts' fears in a batch of 4-week data released at the meeting of the American Association for the Study of Liver Diseases.