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. Read More
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%). Read More
BEIJING – Legend Biotech Corp., headquartered in Somerset, N.J., filed with the U.S. SEC last week plans to raise up to $100 million to advance its BCMA-targeting CAR T candidate, LCAR-B38M, by listing on Nasdaq. Legend confidentially submitted a draft registration statement to the regulators in March. Read More
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. Read More
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. Read More
Except for breakthrough devices and qualifying infectious disease drugs, the footwork for getting Medicare's new technology add-on payment (NTAP) can be more challenging than that needed to win FDA approval. It could be even tougher for products that use artificial intelligence (AI) or that follow a subscription model for pricing. Read More
LONDON – After announcing its $17.4 million series A funding in the midst of pandemic in April, Genespire Srl has now gone public on the preclinical research upon which its programs will be based, presenting the data at last week’s American Society of Gene and Cell Therapy (ASGCT) annual meeting. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adamis, Akebia, Astrazeneca, Biosig, BMS, Carsgen, Cyclo, Cytodyn, Daiichi, Genentech, Lidds, Nantkwest, Sellas, Teva, Vistagen.
