Kenya Launches Malaria Vaccine Pilot Program

Kenya Launches Malaria Vaccine Pilot Program

Kenya has become the third African country, along with Ghana and Malawi, to launch a pilot program for the world’s first malaria vaccine, Mosquirix, which has been developed by GlaxoSmithKline (GSK). The vaccine is available to children from six months of age in specific locations in Kenya due to its phased pilot introduction.1 2 Malaria […]

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 […]

Pfizer Fined Again for Violating Drug Laws

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 […]

Skin Inflammation in Elderly Obstructs Vaccine Efficacy

Skin Inflammation in Elderly Obstructs Vaccine Efficacy

Story Highlights It is known that people over 65 do not respond well to vaccination because aging immune systems do not mount a robust immune response to pathogens. A 2018 study showed that that an excessive inflammatory response at the skin level in elderly patients obstructs immune system function and diminishes a vaccine’s efficacy. The […]

Google Joins the Pharmaceutical Industry

Google Joins the Pharmaceutical Industry

Story Highlights Google, the world’s most widely used internet search engine, restructured itself to give semi-independence to its many subsidiary organizations under a new umbrella entity called Alphabet. Two of the divisions are focused on the business of medicine and operate in partnership with some of the world’s most powerful pharmaceutical companies that develop and […]

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. […]

Lyme Disease Vaccines: Past and Future

Lyme Disease Vaccines: Past and Future

Story Highlights A new Lyme disease vaccine candidate approved by the FDA using the fast track process is currently in its second phase of clinical trials. In 1998, the FDA granted licensure for a Lyme disease vaccine called LYMErix. Following reports of severe adverse reactions to LYMErix, GlaxoSmithKline (formerly SmithKline Beecham) withdrew the vaccine from […]

Former FDA Commissioner Gottlieb Joins Pfizer

Former FDA Commissioner Gottlieb Joins Pfizer

Former Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD has joined the board of directors of Pfizer, Inc.—the world’s largest pharmaceutical company and second largest manufacturer of vaccines. Pfizer, which posted total revenues of $53.7 billion in 2018, announced Dr. Gottlieb’s election to the board on June 27, 2019.1 2 3 4 Dr. Gottlieb, […]

HPV Vaccine Mandated for All 10-Year-Old Girls in Costa Rica

HPV Vaccine Mandated for All 10-Year-Old Girls in Costa Rica

In October 2017, the government of Costa Rica added the human papillomavirus (HPV) vaccine to the country’s national vaccination program. The decision to do so was based on the recommendation of the Costa Rican Ministry of Health’s National Commission on Vaccination and Epidemiology (CNVE), which is the Costa Rican government’s equivalent of the U.S. Centers […]