We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Health insurer Humana has filed a lawsuit against Teva Pharmaceuticals seeking to recover “substantial costs” it incurred in recalling and replacing the company’s heartburn drugs. Read More
The FDA expects sponsors of breast cancer trials to include men as well as women and the scarcity of men with the condition is not an acceptable reason for excluding them from a trial, according to a new final guidance from the FDA. Read More
Mexico’s drug regulators have approved RedHill Biopharma’s planned phase 2/3 trial of Yeliva (opaganib) in hospitalized COVID-19 patients with pneumonia. Read More
Vir Biotechnology plans to launch a phase 2/3 trial this month of VIR-7831, a neutralizing monoclonal antibody for the treatment of COVID-19 patients. Read More
Moderna has secured a $1.5 billion Operation Warp Speed contract to supply 100 million doses of a COVID-19 vaccine candidate to the U.S. government, with an option to supply 400 million more doses if needed. Read More
Fee-paying drug sponsors who submit investigational new drug (IND) applications to the FDA generally get high-quality responses and communications from the agency, according to an independent assessment by Lexington, Mass.-based Eastern Research Group. Read More
Mexico has agreed to host several phase 3 clinical trials of potential COVID-19 vaccines as the pace of research worldwide continues to gain momentum. Read More
Novavax plans to have enough COVID-19 vaccine manufacturing capacity to meet U.S. demand at a minimum, but the Maryland-based vaccine developer is also looking to be able to supply billions of doses next year, the company’s CEO said. Read More
Moderna said that it might not be the first company to make the inventions claimed on patent applications for its COVID-19 vaccine mRNA-1273, and that the company may have to seek patent licenses to market the vaccine. Read More