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The findings are in line with newly published data from the UK Health Security Agency, which showed reduced vaccine effectiveness against Omicron vs. the Delta variant. Read More
Gilead and Bristol-Myers Squibb (BMS) are touting positive data from studies of their bespoke CAR-T cell treatments, each company hailing the results as a new treatment era for patients with relapsed or treatment-resistant large B-cell lymphoma. Read More
Moderna says its messenger RNA flu vaccine candidate, mRNA-1010, successfully boosted titers against all four influenza strains it’s being tested against during an ongoing phase 1 study, even at lowest dose, and that no significant safety concerns were observed. Read More
The FDA has published further draft guidance on real-world evidence (RWE), this time outlining regulatory considerations for noninterventional studies that use real-world data (RWD). Read More
Aprea Therapeutics has received FDA clearance to continue its eprenetapopt development, with the lifting of a full clinical hold placed last summer on the drug’s nonHodgkin’s lymphoma clinical trial program. Read More
The Pfizer/BioNTech and Moderna COVID-19 vaccines are 25-40 times less effective against the new Omicron variant than the original strain and Delta variants, two new laboratory studies have found. Read More
Merck’s islatravir-based HIV antiretroviral program has hit another bump in the road, with the company pausing enrollment in two phase 3 studies that are key to advancing the once-a-month oral regimen. Read More