Good morning, everyone, and how are you today? We are doing just fine, thank you, despite the cloudy skies looming over the Pharmalot campus. After all, the birds are still chirping and a cool breeze is wafting by. And so, we are dutifully concocting a few needed cups of stimulation as we dig in for another busy day. No doubt, you can relate. Our choice today is butter pecan. And so now, the time has come to get cracking. As always, we have assembled some items of interest for you. So hoist your own cup to a successful day and drop us a line when something interesting arises…
Under the reign of Francis Collins, the National Institutes of Health was untouchable, STAT notes. From virtually the moment President Obama appointed him in 2009, prominent figures in government and science have been enchanted by the Harley-riding, guitar-playing geneticist who brought newfound attention to the nation’s medical research agency. In less than a decade, the NIH budget ballooned from $29 billion to $42 billion. In an era when Democrats and Republicans agreed on nothing, the NIH’s popularity served as a rare unifier under three presidents. But his popularity obscured a debate raging in university laboratories and biotech boardrooms across the country: Is the biomedical sciences agency living up to its mission? Or, more fundamentally: What should its mission be?
The U.S. Food and Drug Administration declined to approve an Eli Lilly (LLY) lung cancer drug that had been studied only in China, Reuters tells us. The decision comes after an FDA advisory panel in February recommended that Lilly and its partner, Innovent Biologics, should be required to conduct a trial of the drug, called sintilimab, that is applicable to the U.S. population. In a complete response letter, the agency recommended an additional multi-regional clinical trial. The agency’s decision raises concerns for other Chinese drugmakers that have been seeking to bring their products to the U.S. market at lower costs by conducting a single-country clinical trial.
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