This week, Medtronic recalled a nerve monitoring system due to reports of false responses. The US FDA approved the first auto-injector for opioid-overdose, made by Purdue Pharma. The agency granted de novo authorization for Labcorp’s PGDx elio plasma focus Dx used by labs for genetic profiling. As of 7 August, 950 AI/ML devices have been approved by the FDA. EKO Health teamed up with LSU to help detect arrhythmias and murmurs in student-athletes.

Restructuring Edition: Vir will end influenza, COVID-19 and T-cell-based viral vector platform programs to focus on clinical hepatitis and cancer assets. Also, FibroGen cut 75% of its workforce after a clinical trial failure, while Arbutus, HilleVax, Pfizer and others also announced layoffs.

Featuring deals involving Novartis/Dren, Palvella/Pieris, Eyenovia/Senju, Addex/Johnson & Johnson, Agilent/BioVectra, Meitheal/Nabriva, plus tech transfer agreements and deals in brief.

After expanding its local portfolio through acquisitions and partnerships, Chiesi is now aiming to build its presence in Japan's rare disease sector over the long term, helped by development of global products and possible new alliances.