Genetically Engineered Cow Plasma Therapy for COVID-19 Will Be Tested on Humans

Genetically Engineered Cow Plasma Therapy for COVID-19 Will Be Tested on Humans

Story Highlights Human trials for a new COVID-19 immunotherapy candidate (SAB-185) that is derived from genetically engineered cow plasma will begin in July 2020. The cows have been genetically engineered to produce human antibodies to fight off COVID-19. Plasma from the cows is expected to assist COVID-19 patients overcome the infection. SAb Biotherapeutics (SAB), a […]

Rapid Tests for Coronavirus Raise Concerns Over Accuracy

Rapid Tests for Coronavirus Raise Concerns Over Accuracy

On Mar. 27, 2020, the U.S. Food and Drug Administration (FDA) issued Emergency Use Authorization (EUA) to pharmaceutical and medical devices company Abbott Laboratories, Inc. of Abbott Park, Illinois for a rapid diagnostic test for the SARS-CoV-2 virus known as ID NOW.1 2 3 “We know how important it is to get point-of-care tests out […]

Anti-Depressants in Short Supply During COVID-19 Lockdowns

Anti-Depressants in Short Supply During COVID-19 Lockdowns

Drug shortages listed by the U.S Food and Drug Administration (FDA) are exposing some of the ramifications of responses to the COVID-19 pandemic, including state lockdowns and social distancing regulations.1 Zoloft (sertraline hydrochloride), an anti-depressant manufactured by Pfizer and its generic counterparts produced by other drug makers, have been added to the FDA’s list of […]

COVID-19 Related Drug Shortage in U.S. Because China Supplies Most Ingredients

COVID-19 Related Drug Shortage in U.S. Because China Supplies Most Ingredients

Story Highlights The FDA has reported its first drug shortage as a result of the COVID-19 outbreak in China. Many drug ingredients and finished drug products used in the U.S are sourced and manufactured in China. The possibility of potential drug shortages highlights the issue of how the U.S. is heavily reliant on China for […]

Chinese Pharmaceutical Industry Competes for Vaccine Market Share

Chinese Pharmaceutical Industry Competes for Vaccine Market Share

China’s National Medical Products Administration has announced that two Chinese pharmaceutical companies, Walvax Biotechnology and Innovax, have been approved to start selling their own version of drugs previously available only through global pharmaceutical giants Pfizer, Merck and GlaxoSmithKline.1 Cecolin, developed by Innovax, will compete in the Human Papilloma Virus (HPV) arena against Merck’s Gardasil and […]

Tamiflu on Track to Be an Over-The-Counter Drug

Tamiflu on Track to Be an Over-The-Counter Drug

In July 2019, drug and French vaccine manufacturer Sanofi signed a deal with Roche Pharmaceuticals to obtain exclusive over-the-counter (OTC) rights for Tamiflu (oseltamivir), an antiviral drug licensed for the treatment of influenza infections. Genentech, a member of the Roche Group, currently sells Tamiflu in the United States only for prescription use.1 Tamiflu is a […]

Vaccine Market Valued at $93 Billion by 2026

Vaccine Market Valued at $93 Billion by 2026

A recent report by Fortune Business Insights projects the value of the world market for vaccines to reach $93.08 billion by 2026, with a Compound Annual Growth Rate (CAGR) of 10.7 percent during the forecast period.1 One of the main drivers of the vaccine market is the need for greater supplies of vaccines, given stricter government […]

GlaxoSmithKline Partners with Viome to Develop New Vaccines

GlaxoSmithKline Partners with Viome to Develop New Vaccines

Vaccine manufacturer GlaxoSmithKline (GSK) of the United Kingdom has partnered with Viome, a gut microbiome test company in Seattle, Washington to better understand bacteria that live in the digestive tract and the role they play in the body’s immune system response.1 According to Emmanuel Hanon, senior vice president for research and development at GSK Vaccines, […]

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 […]

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