LONDON - EMA Director General Guido Rasi has hit out at the lack of coordination in COVID-19 clinical trials, questioning if the huge number of small studies that are running will support regulatory decision-making.
Balt USA LLC, of Irvine, Calif., has received a thumbs up from the FDA to begin an IDE trial of its Squid liquid embolic device for the treatment of chronic subdural hematoma (cSDH). The nonadhesive agent offers a minimally invasive option for a disabling neurological condition that often requires brain surgery to correct.
Dry eye disease is a common problem, and Sight Sciences Inc., of Menlo Park, Calif., is looking to help those who suffer from the condition. Now, the company has seen the presentation of positive clinical data from the multicenter OLYMPIA study of Tearcare, which the company has heralded as the first wearable and intelligent eyelid technology for dry eye treatment.
BOGOTA – Mexican home appliances manufacturer Mabe Sa De Cv, from Mexico City, became a new member of the med-tech sector after taking the leap forward and joining the scores of companies around the world shifting their traditional manufacturing lines to develop med-tech products to fight COVID-19.
A global HIV prevention study comparing a long-acting injectable antiretroviral from Viiv Healthcare Ltd. to a daily pill from Gilead Sciences Inc. has stopped early after Viiv's cabotegravir proved 69% more effective than the current standard of care, Gilead's Truvada (emtricitabine/tenofovir), in preventing HIV acquisition (95% CI 41%-84%).
Women, black and Hispanic/Latinx participants were underrepresented in pivotal clinical trials for drugs approved from 2007 to 2017, according to a new report by the Tufts Center for the Study of Drug Development. In the pivotal clinical trials, 44.9% of patients were women. Participants who identified as black or of African descent were the most underrepresented participant group, representing 5.4% of participants in clinical trials.
Moderna Inc.’s chief medical officer, Tal Zaks, said that the results in hand “give us great confidence that we've got the right dose range for phase III” work slated to begin this summer with COVID-19 vaccine prospect mRNA-1273. A regulatory filing could come as early as 2021.
LONDON – Oculis SA has delivered positive phase IIb data for OCS-01, a topical nanoparticle formulation of dexamethasone, in the treatment of the after-effects of cataract surgery, meeting the primary endpoints of reducing both inflammation and pain.