In the Know: Healthcare News from Medical Alley for July 6, 2020

Envoy Medical Receives FDA Breakthrough Device Designation for its Fully Implanted Acclaim® Cochlear Implant Study design for CVRx device can serve as heart failure model: JACC editorial Philips ranked as world’s most innovative medtech company in Boston Consulting Group’s Annual Report Takeda Receives U.S. FDA Approval to Manufacture ENTYVIO® (vedolizumab) Drug Substance at Manufacturing Facility […]

In the Know: Healthcare News for May 11, 2020

Rebiotix and Ferring announce world’s first with positive preliminary pivotal Phase 3 data for investigational microbiome-based therapy RBX2660 3M completes $650M drug delivery unit sale, but business to remain in Twin Cities Predictive Oncology Initiates $2.2M Direct Stock Offering Study tests revolutionary treatments for depression The Lacek Group Expands Healthcare Practice and Joins Medical Alley […]

FDA Issues Final Guidance on Conduct of Clinical Trials of Medical Products During COVID-19 Pandemic

Via Faegre Drinker “On March 18, the U.S. Food and Drug Administration (FDA) issued a final guidance titled FDA Guidance on Conduct of Clinical Trials of Medical Products During COVID-19 Pandemic, providing important guidance for industry, investigators and institutional review boards on conducting clinical trials amidst the pandemic. The guidance, finalized without a public consultation period, […]

President Donald Trump Declared a National Emergency to Combat Coronavirus – What Happens Now?

Via Faegre Drinker “The declaration of a national emergency determines the legal and operational resources available to respond to an emergency, such as the outbreak of COVID-19, by increasing federal officials’ powers to respond to and assist states and localities through emergency protective measures undertaken to reduce an immediate threat to life. By invoking the […]