Topic:

Clinical Trials

Latest Headlines

Latest Headlines

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.

UPDATED: Safety concerns cloud odanacatib PhIII as Merck steps back from FDA filing

A growing buzz about potential safety issues has raised a cloud of doubt about Merck's osteoporosis drug odanacatib, which is likely to linger now that the pharma giant has released Phase III results and laid out plans for a delayed FDA filing.

Roche's Genentech triggers its PhIII program for blockbuster AMD contender

Following up on a successful mid-stage study for the AMD eye drug lampalizumab, Genentech has triggered a pair of Phase III studies to see if it can extend its blockbuster-making R&D rep beyond the cancer drug sphere.

Avanir skyrockets as controversial generic combo claims a hit in PhII Alzheimer's study

Avanir's combinatorial approach to calming dementia-related outbursts among Alzheimer's patients caught the attention of Wall Street on Monday morning. The biotech touted midstage data demonstrating that a match of two treatments--a generic cough suppressant and a long-approved treatment for irregular heartbeats--significantly reduced the level of agitation among the patients in the study.

Recruitment specialist Trialbee snags a deal with AstraZeneca

Trialbee, a Swedish patient-recruitment outfit, has added AstraZeneca to its client roster, bringing its direct-to-patient technology to the U.K. drugmaker.