The drug store giant Walgreens (Nasdaq:WBA) has launched a clinical trial business aimed at optimizing patient experience, recruitment and clinical trial diversity. Deerfield, Illinois–headquartered Walgreens will offer both in-person and virtual care clinical trial options. In a press release, Walgreens underscored FDA’s push to improve racial and ethnic diversity in clinical studies. In 2020, three-fourths…
Axogen announces positive topline data from Phase 3 nerve graft study
Focused on developing peripheral nerve regeneration and repair products, Axogen (Nasdaq:AXGN) announced that the Phase 3 RECON study met its primary endpoint in comparing its Avance nerve graft to conduits in digital nerve injuries. The primary endpoint was the return of sensory function based on static two-point discrimination. This test measures the ability to detect…
The COVID-19 effect: Research platforms require new capabilities
Like a Category 5 hurricane, COVID-19 has uprooted traditional clinical trial methods to clear space for emerging models and practices to grow and flourish. Three related and complementary trends will have a profound and lasting impact. The shift to virtual/decentralized clinical trials. The popularity of decentralized clinical trials (DCTs) skyrocketed following the nationwide lockdown last March.…
Is J&J’s COVID-19 vaccine linked to tinnitus?
In Johnson & Johnson’s (NYSE:JNJ) Phase 3 trial for the Ad26.COV2.S COVID-19 vaccine, six vaccine recipients developed tinnitus or ringing in the ears. In five of those individuals, tinnitus had either resolved or was resolving. The condition was unresolved in the other trial volunteer. No placebo recipients developed the condition. J&J concluded that the tinnitus reports…