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As the COVID-19 pandemic wore on, industry clamored for the US FDA to re-inspect troubled drug manufacturing plants remotely if need be to clear them for new approvals. Now FDA investigators are out in force and early returns from Sun, Aurobindo, Lupin and Sterling suggest these re-inspections will be as tough as ever.
Two-month inspection during pandemic highlighted cross-contamination risks and process validation shortfalls at New Jersey plant.
In tandem with buying the rest of Kleo, Tonix licenses molecular degradation technology from Yale. Neurogene, University of Dundee partner on cell therapies for neurological disorders.
Given effect corticosteroids have on patients, US FDA asks whether they can be excluded from use in alcoholic hepatitis clinical trials.
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