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- FDA draft guidance seeks clearer, more flexible QSP dose selection for first-in-human trialsIndustry groups have asked the FDA for more clarity in a draft guidance that outlines how sponsors can use quantitative systems pharmacology (QSP) to select doses for first-in-human studies. The r…
- An eye drug biotech banks $118M and stocks its executive suiteClaris Bio has appointed veteran CEO Stephen Brady to lead advanced development of what it hopes to be the first drug therapy for a blinding condition called limbal stem cell deficiency.