Â鶹ŮÓÅ

Philips is recalling its remote cardiac monitoring software, which has been associated with 109 reported injuries and two reported deaths, according to the Food and Drug Administration. The agency labeled the action a Class I recall, its most serious designation. (Dubinsky, 1/14)

Approvals for drugs from Biogen Inc. and Sarepta Therapeutics Inc. show flaws in the process US drug regulators use to speed approval for drugs to fill unmet needs, federal watchdogs said in a report. Biogen’s Aduhelm, Sarepta’s Exondys 51, along with Covis Pharma’s Makena were all cleared quickly by the US Food and Drug Administration despite weak evidence and disagreements among reviewers, according to the report Tuesday from Department of Health and Human Services’ Office of Inspector General. In one case, documentation about key decisions was missing, the report found. (Rutherford, 1/14)

CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator) today announced an award of $3.5 million to biotechnology company Melio to develop a rapid diagnostic test for bloodstream infections, including neonatal sepsis. Melio's culture-free diagnostic platform uses molecular and microfluidic technology to identify clinically relevant pathogens and actionable antibiotic-resistance markers directly from blood within 3 hours. Company officials say the platform could enable providers to make early, targeted antibiotic treatment decisions and fill a crucial gap in sepsis care for newborns. (Dall, 1/14)