In May 2024, BioWorld covered 298 updates across phase I-III clinical trials, surpassing March (261), February (236) and January (252), though falling short of April’s high of 323. Additionally, at the end of May BioWorld revised its reporting criteria for clinical trial updates, focusing mainly on data readouts and excluding trial initiations, enrollment changes and initial patient dosing, thereby impacting the update count relative to prior months.

Clarius Mobile Health Corp. received U.S. FDA clearance for the Clarius OB artificial intelligence biometric measurement tool, which is designed to improve access to accurate prenatal monitoring in low-resource regions. The system automatically estimates fetal age, weight and growth intervals critical to assessing fetal health and early identification of potential issues and multiple pregnancies.

Nexsen Biotech Pty Ltd. developed a rapid diagnostic test for Group B Streptococcus, a highly prevalent and potentially fatal bacteria that is the single largest maternal health problem faced by pregnant mothers.

Agilemd Inc. received U.S. FDA clearance for its Ecart clinical deterioration suite, an artificial intelligence-powered software as a medical device that uses a machine learning algorithm to continuously evaluate the risk of a hospitalized patient’s death or transfer to intensive care based on 97 real-time variables.

The U.S. FDA reissued a 2022 draft guidance for clinical trial diversity at the behest of legislation from Congress, ballooning the previous nine-page draft to 23 pages.

After spending years battling with Apple Inc. over the consumer heart monitoring market Alivecor Inc. is hoping to bring its technology to the professional health care market with its new device, which recently received clearance from the U.S. FDA.

The U.S. FDA granted approval of Verona Pharma plc’s ensifentrine on its PDUFA date of June 26, giving the chronic obstructive pulmonary disease (COPD) community its first new mechanistic option in a decade. The drug, branded Ohtuvayre, is also the first inhaled nonsteroidal therapy to treat a respiratory disease that combines both a bronchodilator and anti-inflammatory mechanism into one molecule. It is indicated for the maintenance treatment of COPD, which Verona said allows for broad use.

Concerto Bioscience Inc. has received FDA clearance of its IND application to initiate a first-in-human phase I trial of Ensemble No.2 (ENS-002), an investigational live biotherapeutic product to treat atopic dermatitis.

In May, the U.S. FDA approved 11 new drugs, a significant drop from the 26 approvals in April, which was the sixth-highest monthly total since 2016. This also falls short of March’s record-setting 30 approvals, the highest number recorded by BioWorld.