clinical trials

23andMe and TrialSpark Announce Request for Clinical Trial Proposals

23andMe, the consumer genetics company, and TrialSpark, a technology company that helps physician practices become clinical trial sites, are announcing a joint clinical trial offering that combines the power of 23andMe’s crowdsourced research platform and extensive database of consenting customers with TrialSpark’s distributed site network and trial services.

FDA Calls for More Participation and Diversity in Trials

FDA Calls for More Participation and Diversity in Trials

The U.S. Food and Drug Administration (FDA), which relies heavily on the results from clinical trials, is encouraging more patients to participate in trials—particularly people of all ages, races, ethnic groups and genders—as it will give the Administration a more clear picture of a product’s risks and benefits. The FDA notes that there can be significant differences in how diverse populations respond to medical products, and that information can be added to the label to help doctors and patients make treatment decisions.

Brodalumab Effective for Plaque Psoriasis

A Phase 3 clinical trial, called AMAGINE-2, evaluating three doses of brodalumab (Amgen/AstraZeneca) in patients with moderate to severe plaque psoriasis successfully met its key primary and secondary endpoints when compared to Stelara (ustekinumab) and placebo at week 12.

Brodalumab, a human monoclonal antibody, targets and binds to the interleukin-17 (IL-17) receptor and blocks several IL-17 cytokines (A, F and A/F) from binding there, inhibiting inflammation. It is also being investigated for the treatment of psoriatic arthritis and asthma.

AbbVie Announces Phase 3 Data on HUMIRA for HS

AbbVie Announces Phase 3 Data on HUMIRA for HS

AbbVie has released the results from a Phase 3 pivotal study demonstrating that HUMIRA (adalimumab) is effective in reducing the number of abscesses and inflammatory nodules in moderate-to-severe hidradenitis suppurativa (HS), also known as acne inversa. The data were presented at the 44th[SUPERSCRIPT TH] Annual European Society for Dermatological Research (ESDR) Meeting in Copenhagen, Denmark.