Hello, everyone, and how are you today? Cloudy skies are hovering this morning over the Pharmalot campus, where things have settled down now that the short person has returned to the institution of higher learning and the official mascot has assumed his formal snoozing position. As for us, we are dutifully concocting a few needed cups of stimulation as we dig in for another busy day — our choice today is cinnamon hazelnut. No doubt, you can relate. So time to get cracking. As always, we have assembled some items of interest. So hoist your own cup to a successful day, and drop us a line when something interesting arises. …
Newly released data showed a GSK vaccine for respiratory syncytial virus, or RSV, was 82.6% effective in a late-stage study involving older adults, Reuters writes. RSV is a leading cause of pneumonia in toddlers and the elderly, causing thousands of hospitalizations and deaths each year, but the complex molecular structure of the virus and safety concerns have stymied efforts to develop a vaccine. The trial, which involved about 25,000 adults aged 60 and up, showed the vaccine was 94% effective against severe lower respiratory tract disease associated with an RSV infection. If approved, Jefferies analysts forecast $2.5 billion in global RSV vaccine peak sales in older adults for GSK.
Eisai is “extremely confident” of winning full U.S. approval for its experimental Alzheimer’s drug, paving the way to broad coverage under Medicare insurance for elderly Americans, Bloomberg News reports. “The data is indisputable,” Eisai chief executive officer Haruo Naito said in an interview in Tokyo. “The drug met primary and secondary endpoints perfectly and has a manageable safety profile.” The U.S. Food and Drug Administration is reviewing the drug, called lecanemab, under a special “accelerated approval” pathway. A decision is expected by Jan. 6. The drug significantly slowed Alzheimer’s, and the breakthrough makes it the first to blunt progression of dementia in a large-scale trial.
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