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