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Former FDA Commissioner David Kessler is set to become Operation Warp Speed’s new chief science officer as just a single day remains until the Biden presidency takes up the mantle for accelerating COVID-19 vaccinations and countermeasures. Read More
The FDA has issued straight-to-final guidance that provides sponsors of monoclonal antibody and other therapeutic protein COVID-19 treatments with recommendations for potency assays to ensure consistent product quality. Read More
Billionaire and television personality Mark Cuban has unveiled the Mark Cuban Cost Plus Drug Company, which aims to produce low-cost versions of expensive generics. Read More
UK drugmaker Synairgen has dosed the first patient in a global phase 3 trial evaluating an inhaled formulation of interferon beta-1a, SNG001, for treating hospitalized COVID-19 patients who require supplemental oxygen. Read More
Oxford Immunotec is teaming up with Valneva to help the French biotech with a phase 1/2 UK trial of its inactivated COVID-19 vaccine candidate, VLA2001. Read More
FDA veteran Janet Woodcock has reportedly been short-listed by the incoming Biden administration to serve as the agency’s next commissioner and will also likely serve as acting chief until the position is filled. Read More
In observance of Martin Luther King Jr. Day, Drug Industry Daily will not be published Monday, Jan. 18. The next issue will be published Tuesday, Jan. 19. Read More
The Endocrine Society, a large physicians’ group, is calling on policymakers to include government negotiation as part of an overall strategy to reduce insulin prices. Read More