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 […]
Pfizer Fined Again for Violating Drug Laws
Colombia’s national regulatory agency, the Superintendency of Industry and Commerce (SIC), has fined pharmaceutical company Pfizer $25,000 for allegedly inflating the price of several prescription drugs it sold in that country.1 2 On July 31, 2019, the agency stated: The decision was taken after verifying information related to PFIZER SAS’ commercial operations between July and December […]
Is Merck’s Measles Vaccine Monopoly a Cause for Concern?
First, how did Merck become the country’s sole supplier of these measles vaccines, and is that a problem? Well, is it a problem depends on who you talk to. But Merck became the sole supplier because the vaccine market is highly concentrated. It’s incredibly expensive to make vaccines. It takes a lot of time to […]
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. […]
Pharmaceutical Fraud
The story I’m going to tell today begins just before the turn of the century. The year is 1999 and Merck has brought a new pain killer onto the market called Vioxx. According to a paper published in the British Medical Journal, since the early development of Vioxx some scientists at Merck were concerned that […]
Merck Plans to Up Production of Experimental Ebola Vaccine
In response to the current outbreak of Ebola in the Democratic Republic of the Congo (DRC) which began in August 2018, the World Health Organization (WHO) has declared the outbreak a Public Health Emergency of International Concern (PHEIC). There have been about 2,500 confirmed cases of Ebola in the DRC and at least 1,737 people have […]