DUBLIN – Apeiron Biologics AG reported March 12 that APN-01, recombinant angiotensin converting enzyme 2 (ACE2; alunacedase alfa) failed to attain the primary endpoint of lowering all-cause death or the need for invasive mechanical ventilation in hospitalized patients with severe COVID-19.

What started with Austrian regulators suspending use of one batch of Astrazeneca plc’s COVID-19 vaccine has expanded into precautionary holds in Denmark and other EU countries as PRAC, the EMA’s safety committee, investigates whether blood clots, which have resulted in at least two deaths in Europe, are connected to the vaccine.

The U.S. FDA has granted emergency use authorization (EUA) to Breath Direct Inc. for its BDR-19 critical care ventilator for the treatment of critical care patients with respiratory insufficiency. Initial shipments of the device are expected within weeks. The EUA marks a major milestone for the fledgling Long Beach, Calif.-based company, which was started by medical device entrepreneur Darren Saravis in the early days of the pandemic.

LONDON – New research shows it is possible to diagnose Parkinson’s disease by mass spectrometry analysis of sebum samples taken with a simple skin swab, and that the same technique has potential to be used for diagnosing COVID-19. In a paper published in Nature Communications on March 11, 2021, scientists and clinicians in the U.K. and the Netherlands describe using high resolution mass spectrometry to profile the chemical signature of lipids and other biomarkers in sebum from Parkinson’s patients and show how these exhibit subtle but fundamental changes as the disease progresses.

LONDON – The largest study of its kind to date has identified new biomarkers of inflammation that are both indicators of severe COVID-19 infection and distinguish it from severe influenza.