Topic:

Clinical Trials

Latest Headlines

Latest Headlines

Amgen, AstraZeneca's brodalumab beats J&J's Stelara in 2nd PhIII psoriasis showdown

Amgen and AstraZeneca have racked up their third straight Phase III win for brodalumab in plaque psoriasis, beating J&J's Stelara in a head-to-head study. The news comes just two weeks after the pharma partners posted their latest positive results, positioning them for a run at regulators on both sides of the Atlantic.

Feds want more trial results made public

The Department of Health and Human Services and the National Institutes of Health are proposing new rules that would greatly expand the number of clinical trials required to publicize their results, a move that could change how CROs handle data.

Medidata and TransCelerate beat the drum for risk-based monitoring

Medidata and partner TransCelerate BioPharma, a nonprofit run by the world's largest drugmakers, are amplifying their call for clinical trial runners to embrace new technology, unveiling study results that support the adoption of risk-based monitoring.

Themis, Institut Pasteur expand collaboration on solid PhI Chikungunya results

Themis Bioscience and the Institut Pasteur have good news to report from a Phase I trial of their Chikungunya fever vaccine candidate. And the pair thinks its successful results just might lead to advances in other diseases, too.

Clovis shares dented after lung cancer contender mirrors AstraZeneca's rival

Shares of Clovis Oncology slid 10% on Wednesday as investors and analysts juggled a new data set on its closely watched lung cancer drug rociletinib (CO-1686). Even though the updated Phase II results were promising, the numbers slipped a bit from its last snapshot delivered last summer at ASCO. And slipping now looks a lot like falling behind in its race with AstraZeneca's rival AZD9291, frequently touted as one of the pharma giant's top R&D comeback programs.

NewLink Ebola vaccine trial to start in Canada

In Canada, which has no reported cases of Ebola, people are lining up to get in on a clinical trial for an Ebola vaccine.

Success or failure, feds want trial results posted online

Federal regulators are proposing a rule that would require makers of drugs and medical devices to publicize the results of thousands of clinical trials, regardless of whether they succeed, part of a global move toward transparency in R&D.

Bind shares dented after heralding cancer drug data from a mixed PhII

Bind Therapeutics believes its lead nanoparticle treatment can make a difference for a subgroup of lung cancer patients, pointing to some positive results from an otherwise mixed mid-stage trial as it prepares for further study.

FDA orders CytRx to halt patient enrollment after death of a cancer patient

CytRx has run into an unexpected roadblock with its cancer drug conjugate aldoxorubicin, slamming the brakes on new patient recruitment in all their clinical trials after the FDA dropped a partial clinical hold on the program. According to the biotech the hold was forced by the death of a patient who was given the drug through a compassionate use program.

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.