Keeping Track: Incomplete Responses For Unusual Times; Qtrypta Is Latest CRL
Highlights from complete response letter news from the Pink Sheet’s US FDA Performance Tracker.
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Cash is available for start-up, growth-stage and public companies through Texas Medical Center’s newly doubled venture fund, a pandemic preparedness initiative and new VC funds. In recent financings, Nutcracker closed a $167m series C round and 2Seventy raised $170m in a private placement.
Moving away from its earlier hospital-based focus with the novel antibiotic, Nabriva also thinks selling Merck & Co.’s Sivextro will provide complementary business.
Office of New Drugs Director Peter Stein tells the Pink Sheet that last phase of massive reorg was complicated by pandemic restrictions that forced review staff to work remotely, but the structural overhaul resulted in smaller, more nimble review groups and the breaking down of silos that ultimately helped the agency’s response to the public health crisis.