The pharmaceutical industry launched a herculean effort to battle the COVID-19 pandemic early in 2020, developing an array of vaccines and other therapeutics while also identifying existing drugs suitable for treating patients sick with severe coronavirus infections. FDA recently granted emergency authorization to two SARS-CoV-2 vaccines and several other treatments. Here are 11 of the…
Trump signs executive order to prioritize U.S. COVID-19 vaccine distribution
President Trump unveiled his latest executive order, which aims to distribute COVID-19 vaccines to American citizens before sending them abroad. “It is the policy of the United States to ensure Americans have priority access to free, safe, and effective COVID-19 vaccines,” reads part of the order. After the HHS Secretary has determined that the U.S. public…
Regeneron antibody cocktail wins emergency use authorization
Regeneron Pharmaceuticals (NSDQ:REGN) has announced that the FDA has granted emergency use authorization (EUA) for the combination of casirivimab and imdevimab to treat COVID-19. The monoclonal antibody cocktail is reportedly the first treatment to show “statistically significant anti-viral activity” against COVID-19, according to its developer. In a trial, the combination of drugs cut hospitalization or emergency…
5 ways Election Day could impact pharma
The pharmaceutical industry stands at a crossroads as Election Day nears in the U.S. The election could ultimately have sweeping implications for the sector, or it could yield only modest changes. While the presidential election could have a significant influence on the pharma sector, arguably more important is who gains control of Congress. A blue…
Guess who the pharma industry is supporting for president
The pharma industry has put its weight behind Democratic presidential candidate Joe Biden, reversing a longstanding fundraising trend that has favored the GOP. Republican candidates have received 64% of pharma industry contributions since 1990, according to the Center for Responsive Politics’ Open Secrets. But the industry is shifting its support to Democrats in 2020. So far,…
FDA defies Trump on vaccine approval timeline
The FDA today told COVID-19 vaccine developers that it needs two months’ worth of safety data before it will consider emergency approvals. The agency’s move cast further doubt on a vaccine against SARS-COV-2 being ready by election day, November 3 — a notion mentioned repeatedly by President Trump in attempts to pressure the agency to…
Report: AstraZeneca Phase III COVID-19 vaccine remains on hold in U.S.
AstraZeneca (NYSE:AZN) is reportedly keeping its COVID-19 vaccine trial in the U.S. on hold as questions remain over patient safety. U.S. Health and Human Services Dept. Secretary Alex Azar told CNBC yesterday that federal investigators are looking for “answers to important questions,” regarding the safety of patients involved in the trial operated by the United Kingdom-based…
Report: Top FDA official vows to quit if vaccine approved prematurely
A top FDA official has threatened to resign if the Trump administration moves too quickly to approve a vaccine for COVID-19, according to a published report. Peter Marks, director of the agency’s Center for Biologics Evaluation and Research (CBER), made the threat over concerns a vaccine would be approved without being proven safe and effective,…