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AstraZeneca (AZ), Sanofi and Eli Lilly have each filed lawsuits against HHS, arguing the federal government can’t force them to provide 340B drug discounts to contract pharmacies. Read More
Internal European Medicines Agency (EMA) documents on pending approvals of COVID-19 vaccines were hacked and leaked online, the agency said last week. Read More
The COVID-19 pandemic has brought out many of the FDA’s strengths, including its commitment to science-based decisionmaking, according to a new report on the agency’s Pandemic Recovery and Preparedness Plan (PREPP) initiative that includes a dozen recommendations for improving the agency’s response going forward. Read More
Participants who received a full two-shot regimen in Moderna’s phase 1 vaccine trial are being given the option to receive a third booster shot through a new clinical trial in the works, the company disclosed last week. Read More
President-elect Joe Biden has committed to invoking the Defense Production Act to bolster the manufacturing of COVID-19 vaccines and supplies needed to administer shots, calling the Trump administration’s efforts to roll out vaccines “a dismal failure.” Read More
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 coronavirus treatment candidate, which is delivered by a pressurized metered-dose inhaler, has both bronchodilator and anti-inflammatory activities, the company said. 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
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