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.
San Diego-based Allele Biotechnology has filed lawsuits against Regeneron Pharmaceuticals, Pfizer and BioNTech, alleging infringement of its patent for mNeonGreen, a reagent used to develop COVID-19 therapies. Read More
The Institute for Clinical and Economic Review (ICER) has launched a cloud-based, cost-effectiveness modeling program for use by health technology assessment (HTA) agencies when projecting COVID-19 treatment costs. Read More
Two FDA expert panels voted in favor of FDA approval for Alkermes’s new drug application (NDA) for its schizophrenia and bipolar disorder investigational drug OLZ/SAM (olanzapine/samidorphan) in a joint session on Friday. Read More
China has officially agreed to support the World Health Organization’s (WHO) COVAX initiative, according to a foreign ministry spokesperson who did not provide the financial details. Read More
The European Commission has inked a supply deal with Gilead Sciences for 500,000 courses of the company’s antiviral drug remdesivir to shore up Europe’s depleting stocks of the COVID-19 treatment. Read More
The Government Accountability Office (GAO) wants the FDA to institute several changes to its three-year-old Office of Laboratory Safety (OLS), which was formed to improve safety in the agency’s labs that work with hazardous biological agents. Read More
Arbor Pharmaceuticals’ AR19, an abuse-deterrent formulation of amphetamine sulfate for attention deficit hyperactivity disorder (ADHD) should not receive FDA approval, two of the agency’s advisory committees voted unanimously in a joint meeting yesterday. Read More