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The FDA cited Takeda biotech subsidiary Baxalta for a host of violations at its Thousand Oaks, California facility, including GMP lapses that could lead to product contamination. Read More
The federal government has granted two contracts worth more than $2 billion as part of Operation Warp Speed — $1.6 billion to Novavax to manufacture and develop its COVID-19 vaccine candidate, and $450 million to Regeneron Pharmaceuticals to manufacture and supply its antibody cocktail to treat COVID-19. Read More
The European Medicines Agency (EMA) has issued a proposed five-year pharmaceutical regulatory plan with six areas of focus including improvements in the drug supply chain. Read More
Emergent BioSolutions has secured a five-year agreement with Johnson and Johnson to manufacture drug substances for J&J’s COVID-19 vaccine candidate. Read More
While several hydroxychloroquine trials in COVID-19 patients have been shuttered, a large study led by Michigan’s Henry Ford Health System (HFHS) has found that the antimalarial drug significantly cut death rates in hospitalized patients and could still hold promise as a COVID-19 treatment. Read More