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The FDA’s Vaccines and Related Biological Products Advisory Committee voted almost unanimously yesterday for Emergency Use Authorization (EUA) of a two-dose primary series of the Novavax COVID-19 vaccine. Read More
Calling the results “a potential new standard-of-care” for pediatric brain tumors, Novartis said its chemotherapy combination of Tafinlar (dabrafenib) and Mekinist (trametinib) reduced the risk of disease progression or death in an ongoing study by 69 percent at 12 months, compared to standard chemotherapy. Read More
A former Eli Lilly employee is suing the drugmaker over allegations she was fired after identifying numerous production issues at Lilly’s Branchburg, N.J., plant, including in the manufacture of the company’s blockbuster, Trulicity. Read More
Johnson & Johnson (J&J) is pulling out of its COVID-19 vaccine supply contract with the troubled drug manufacturing plant, Emergent BioSolutions. Read More
Calquence also maintained efficacy and a sustained safety profile at four years for previously treated patients in the company’s ASCEND trial. Read More
The FDA issued a warning letter to Grimann, an over-the-counter (OTC) drug manufacturer located near Mexico City, for failure to comply with drug registration and listing requirements. Read More
Novartis confirmed Monday it was the victim of a cyberattack that ended in stolen data but maintained the hackers didn’t get away with any sensitive information. Read More