A trio of regulators devised a series of good machine learning practices in 2021, a key point of consideration for many algorithms that will eventually be used in thousands of medical applications in the coming years.

Kbio Inc. has obtained IND clearance from the FDA for EV68-228-N, a human monoclonal IgG1 against the capsid of enterovirus D68 (EV-D68) designed as an intravenous therapeutic for the treatment of acute flaccid myelitis.

Circle Pharma Inc. has submitted an IND application to the FDA for CID-078, a first-in-class cyclin A/B RxL inhibitor. Pending approval, the company plans to initiate a phase I trial in patients with advanced solid tumor malignancies.

Kalivir Immunotherapeutics Inc. has announced FDA clearance of its IND application for VET3-TGI for patients with incurable, advanced solid tumors.

CSL Behring’s expensive hemophilia B gene therapy is to be reimbursed by the U.K. National Health Service, after the company agreed to an outcomes-based payment scheme. The therapy, Hemgenix (etranacogene dezaparvovec), which has a U.K. list price of £2.6 million (US$3.3 million), was approved under a managed access scheme, in which data will be collected over five years to enable both the long-term effectiveness, and any adverse liver toxicity caused by the transgene, to be monitored.

Two days before the PDUFA date, the U.S. FDA handed down a complete response letter (CRL) for Rocket Pharmaceuticals Inc.’s Kresladi (marnetegragene autotemcel), delaying potential approval of the lentiviral-based gene therapy as the first therapeutic option for leukocyte adhesion deficiency type I, a rare, inherited immune disorder. But the Cranbury, N.J.-based company has suggested that delay won’t be long, as the CRL requests only “limited” chemistry manufacturing and controls (CMC) information – additional CMC data were also cited as the reason for the three-month review extension earlier this year.

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.

The device industry has been clamoring for legislation that would require Medicare coverage for FDA-designated breakthrough devices, a wish that is one step closer to fulfillment as of June 27.