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Novartis Manipulated Data in FDA Biologics License Application

Novartis Manipulated Data in FDA Biologics License Application

On Aug. 6, 2019, the U.S. Food and Drug Administration (FDA) issued a statement saying that Swiss pharmaceutical company Novartis AG submitted a biologics license application (BLA) for the spinal muscular atrophy (SMA) gene therapy Zolgensma (onasemnogene abeparvovec-xioi) with manipulated data and failed to inform regulators until June 28, 2019—more than a month after the […]

MMR Vaccine Sales Boost Merck’s 2019 Revenues

MMR Vaccine Sales Boost Merck’s 2019 Revenues

After the Centers for Disease Control and Prevention (CDC) publicized measles outbreaks in several states beginning in January 2019, on May 1 Merck & Co. announced that it had increased production of its live attenuated (weakened) virus MMR (measles, mumps, rubella) vaccine in response to an increasing demand for the product in the United States. […]

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