Author Archives: Marisa Wexler MS

Europe Awaits Proposed New Framework for Sharing Health Data

The European Commission is expected to propose a new governing framework for health data next month, called the European Health Data Space (EHDS), with the aim of connecting national health systems to facilitate secure and efficient transfer of data across systems in different European nations. The move is expected to…

Edsivo Named Breakthrough Therapy by FDA for COL3A1-positive vEDS

Edsivo (celiprolol) has been granted a breakthrough therapy designation for COL3A1-positive vascular Ehlers-Danlos syndrome (vEDS) by the U.S. Food and Drug Administration (FDA). The designation is meant to expedite the development and review of medicines that are intended to treat a serious condition, and for which early clinical…

Acer Plans Pivotal Trial of Edsivo in COL3A1-positive vEDS

Following a meeting with the U.S. Food and Drug Administration (FDA), Acer Therapeutics is planning to launch a potentially pivotal clinical trial to evaluate the safety and efficacy of its investigational therapy Edsivo (celiprolol). Edsivo was found in a small earlier trial to significantly reduce the rate of…