Topic:

Clinical Trials

Latest Headlines

Latest Headlines

Chimerix scores promising antiviral data from a controversy-fueled PhIII pilot

Chimerix reports that its pilot Phase III study of the powerful antiviral brincidofovir has posted promising preliminary data, cutting the risk of death from lethal adenovirus infections by as much as half or more.

Chimerix, FDA scramble to launch a new clinical study of brincidofovir for Ebola

Back in March, Chimerix hustled to put together a small Phase III pilot program to test its closely watched antiviral brincidofovir for adenovirus infections. Today, CEO Michelle Berrey says the company is now scrambling to put together another overnight study plan for Ebola rather than risk getting hit with a fresh round of compassionate-use demands.

Positive PhIII PONV study brings little Acacia to a crossroads

Acacia Pharma says it gleaned positive results from a Phase III study of its experimental therapy designed to prevent postoperative nausea and vomiting. And now it's brought in the investment banker J.P. Morgan Cazenove to advise the board on what its next steps should be as it tries to position the treatment for regulatory approval and commercialization.

Sunesis shares crushed in a rout after leukemia PhIII ends in defeat

Shares of South San Francisco-based Sunesis were crushed this morning after the biotech put out word that its drug vosaroxin had flunked a Phase III test for acute myeloid leukemia. The stock plunged about 70% on the news that the experimental therapy had failed to significantly improve survival rates compared to a placebo.

EMA adopts open trial data policy to begin Jan. 1

The European Medicines Agency adopted a new policy on Oct. 2 that requires drug companies to make public certain clinical data that predicate drug approvals.

Merck Gardasil follow-up could block 90% of cervical cancers--if uptake improves, that is

Merck's investigational, 9-valent HPV vaccine has the potential to block about 90% of invasive cervical cancer cases worldwide, new research shows. But getting there will be no walk in the park. First, the company will have to solve some uptake problems that have been plaguing the candidate's predecessor, Gardasil, since it rolled out in 2006.

Little Esperion eyes big rivals as its cholesterol drug clears mid-stage hurdle

Esperion Therapeutics has taken another big stride along the clinical path for its cholesterol drug. The biotech reports that its drug ETC-1002 slashed levels of the bad cholesterol LDL, particularly when it was combined with Merck's Zetia, in a Phase IIb trial. And now that the mid-stage program is complete, the Ann Arbor, MI-based biotech finds itself at the threshold of a late-stage program with a drug the company feels can thread the market needle between cheap generics and a looming wave of rival biologics.

GVK accused of tampering with data in Indian clinical trials

Indian CRO GVK Biosciences is working to get back in the good graces of European regulators after inspectors found evidence that its employees doctored clinical trial results.

Gilead heads to FDA after wrapping a PhIII HIV combo drug program

Gilead says that a pair of late-stage studies of its single-tablet combo therapy for HIV hit their primary endpoints, paving the way to an FDA filing later in the year.

TransCelerate dishes on risk-based monitoring

TransCelerate BioPharma, a nonprofit founded by the world's biggest drugmakers to make R&D more efficient, is encouraging developers to adopt risk-based monitoring for clinical trials, disclosing its thinking in two research papers.