Topic:

Clinical Trials

Latest Headlines

Latest Headlines

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.

ASCO: Provista's autoantibody/biomarker combo boosts breast cancer screening accuracy

Provista Diagnostics is celebrating some early clinical data that support its approach of using autoantibodies and serum protein biomarkers together to help differentiate between invasive breast cancer and benign breast conditions.

A respiratory expert undermines GSK's case for new asthma drug mepolizumab

Investigators for GlaxoSmithKline detailed their promising Phase III data for the IL-5 biologic mepolizumab in asthma today, noting that the injectable halved the rate of exacerbations among a group of patients with uncontrolled cases of the respiratory disease. But while the pharma giant was making its case for a lower dosage of the drug for a particular profile of asthma patient, an expert in the field raised the prospect that GSK's biggest competitor in the real world may simply be cheaper therapies applied with proper compliance to the medical guidelines already in place.