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Preliminary results indicate that a Sanofi/GSK booster increased neutralizing antibodies by up to 43-fold, regardless of which vaccines participants originally received. Read More
There are almost 800 drugs for rare diseases either in clinical trials or awaiting review by the FDA, according to a new report by the Pharmaceutical Research and Manufacturers of America (PhRMA). Read More
AstraZeneca’s COVID-19 vaccine becomes completely ineffective against the Omicron variant by 15 weeks, according to real-world British data released yesterday. Read More
Adults infected with the Omicron variant are 29 percent less likely to enter the hospital than people infected with other COVID-19 strains, according to the first large-scale real-world clinical data. Read More
Sanofi and GlaxoSmithKline (GSK) said preliminary data from a phase 3 study showed that a booster dose of their experimental COVID-19 shot induces strong immunity but said they won’t release full trial results until early next year. Read More
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The FDA has published further draft guidance on real-world evidence (RWE), this time outlining regulatory considerations for noninterventional studies that use real-world data (RWD).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