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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The FDA has published further draft guidance on real-world evidence (RWE), this time outlining regulatory considerations for noninterventional studies that use real-world data (RWD).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
Aeglea BioTheraputics hopes to snag a first-in-class approval for its recombinant human enzyme pegzilarginase after finding that the molecule normalized plasma arginine levels in more than 90 percent of patients with ARG1-D, an inability to process the protein. Read More
UCB and Novartis have joined forces in what could be a $1.5 billion deal to develop two investigational molecules targeting alpha synuclein, the misfolded protein involved in Parkinson’s disease. Read More