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.
Teva Pharmaceuticals has another chance to argue it shouldn’t have to pay $235.5 million in damages to GlaxoSmithKline for patent infringement, as the full U.S. Court of Appeals for the Federal Circuit has agreed to review a ruling to that effect. Read More
The U.S. has joined the World Health Organization (WHO)’s Access to COVID-19 Tools (ACT) Accelerator program, a global effort to speed development and production of coronavirus vaccines, treatments and tests, and to help lower-income nations obtain them. Read More
The FDA has unveiled new details on its postmarket safety monitoring of COVID-19 vaccines, including its surveillance for adverse events, that should help vaccine sponsors comply with the agency’s requirements under Emergency Use Authorizations (EUAs). Read More
The World Health Organization (WHO) has issued interim guidance, recommending AstraZeneca’s COVID-19 vaccine for use against the variant first identified in South Africa and for individuals 65 years and older, despite limited supporting data. Read More
The U.S. has secured a hefty supply of COVID-19 monoclonal antibodies, but challenges in administering the potentially game-changing treatments and skepticism around their efficacy have contributed to their minimal use. Now, a newly issued Emergency Use Authorization (EUA) for an antibody combo could inspire greater assurance in the drugs as potential treatments for preventing hospitalization. Read More
The European Medicines Agency (EMA) has expanded the use and scope of remote source data verification (rSDV) in clinical trials as long as patients’ private data can be protected, according to a guidance update released this week. Read More