Topic:

Clinical Trials

Latest Headlines

Latest Headlines

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.

Icon and Medidata unite to give patients a louder voice in clinical trials

CRO magnate Icon and and eClinical outfit Medidata are pooling their resources to offer a combined platform for patient-reported outcomes in clinical trials, touting their technology as faster and more effective in surveying participants.

Merck KGaA scraps a controversial PhIII comeback attempt for cancer vaccine

About a year ago Merck KGaA made the controversial decision to revive its late-stage program for the cancer vaccine Stimuvax, trying to start off fresh by renaming it tecemotide and pointing it toward a subpopulation of non-small cell lung cancer patients which appeared to respond in its very big failed Phase III. Today, the program is--once again--officially terminated.

Roche abandons another Fragile X R&D program after PhII trials flunk out

A long, rough patch in Fragile X syndrome drug R&D just got longer and rougher. Roche has notified patient groups that both of its mid-stage studies for RG7090--an mGluR5 therapy--failed to hit the primary and secondary goals, prompting the pharma giant to shut down the program.