GSK and Sanofi COVID-19 Vaccine Produced in Insect Cells with Squalene Adjuvant

GSK and Sanofi COVID-19 Vaccine Produced in Insect Cells with Squalene Adjuvant

Story Highlights GlaxoSmithKline and Sanofi Pasteur are partnering to develop an experimental COVID-19 vaccine. The two global vaccine manufacturers are using existing recombinant DNA vaccine technology and a squalene adjuvant for their COVID-19 vaccine. Clinical trials are scheduled to begin in the second half of 2020 and, if successful, the vaccine will be available in […]

Fluzone Quadrivalent Influenza Vaccine Approved by FDA for Elderly

Fluzone Quadrivalent Influenza Vaccine Approved by FDA for Elderly

The U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (BLA) for the Fluzone high-dose quadrivalent influenza vaccine for use by adults 65 years of age and older. Fluzone is manufactured by Sanofi Pasteur, Inc. of France.1 2 The Fluzone high-dose influenza vaccine was approved by the FDA in 2009 as […]

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. […]