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.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Agios, Amplyx, Arbutus, Biogen, Covis, Hepion, Lidds, Mezzion, MGB Biopharma.
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.
A new phase IIb readout at odds with earlier data suggesting PTI-125 would diminish key biomarkers of neuroinflammation and neurodegeneration in Alzheimer’s patients has left Cassava Biosciences Inc. President and CEO Remi Barbier looking for answers.
Shares of Allogene Therapeutics Inc. (NASDAQ:ALLO) leapt 36% higher to $42.12 on Thursday after limited data from a small number of relapsed/refractory (r/r) non-Hodgkin lymphoma patients showed a combination of the company's anti-CD19 allogeneic CAR T candidate, ALLO-501, and an anti-CD52 monoclonal antibody, ALLO-647, met with an overall response rate of 78%.
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