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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
Regeneron Pharmaceuticals has begun a phase 3 clinical trial in the U.S. of its antibody cocktail REGN-COV2 for the prevention of COVID-19 infections. Read More
The FDA hit Apertus Pharmaceuticals with a Form 483 for data integrity lapses and other good manufacturing practice (GMP) violations observed during an inspection of its St. Louis, Missouri facility. Read More
The parallel use of human challenge trials and large-scale conventional trials could help accelerate the development of an effective vaccine for COVID-19, NIH vaccine experts say. Read More
A federal appeals court has ruled that two Amgen patents for its blockbuster anti-inflammatory drug Enbrel are valid, blocking the launch of a biosimilar by Novartis. Read More