Orexo AB enrolled the first patient in a pivotal trial of its digital therapeutic Modia plus sublingual buprenorphine/naloxone for treatment of opioid use disorder (OUD). Orexo’s Zubsolv, the combination of buprenorphine and naloxone used in the study, has been employed to help U.S. patients with OUD since 2013.

Pear Therapeutics Inc. released nine-month, real-world data showing long-term reduction in costly health care utilization categories, including inpatient stays and emergency department visits, in patients with opioid use disorder (OUD) who utilize its Reset-O prescription digital therapeutic. The findings suggest that Reset-O could help to stabilize patient outcomes long-term when used in conjunction with outpatient treatment.

Approval could come next year for Furoscix from Scpharmaceuticals Inc. (Scpharma), a solution of the standard-of-care heart failure diuretic furosemide formulated to a neutral pH and designed for outpatient use.

Diagnostics startup Geneoscopy Inc. has enrolled the first patients its pivotal CRC-PREVENT clinical trial. The interventional study will assess the safety and efficacy of the company’s noninvasive, at-home, multifactor RNA screening test for the prevention of colorectal cancer.

Looking to increase adoption among more tobacco users, Carrot Inc. expanded the indications for use of its smoking cessation breathalyzer with a new FDA 510(k) clearance to include the claims related to a recent study in the labeling and promotion of the sensor. The clinical trial demonstrated the Bluetooth-enabled sensor’s ability to increase a person’s motivation to quit.

In infectious disease research, most of the research into genetic determinants of susceptibility to infection and disease severity are focused on the host. For COVID-19, for example, the delta variant’s infectivity, and how likely infection is to lead to severe disease, is the focus of an intense research agenda. But host genetics, too, contribute to the consequences of infections. An ongoing study into the host genetics of SARS-CoV-2 infection has identified 13 such factors that affected either the likelihood of contracting SARS-CoV-2, or the severity of disease, gleaned from the data of 50,000 infected persons and 2 million controls.

A collaboration between Oncosec Medical Inc. and Merck and Co. that yielded positive phase II study data has paved the way for a phase III study between the two companies. Oncosec’s DNA-plasmid interleukin-12 (IL-12) Tavo (tavokinogene telseplasmid) will be combined with Merck's anti-PD-1 therapy Keytruda (pembrolizumab) in a randomized, global phase III study for treating late-stage metastatic melanoma.

New research suggests that ultraviolet (UV) light that operates at lower bandwidth than what currently exists in the market could be just as useful in inactivating the SARS-CoV-2 virus with less harmful effects on skin cells. Joint research by Asahi Kasei Corp. and Nara Medical University confirmed that 226 nanometer ultraviolet-C (UVC) LEDs can inactivate the SARS-CoV-2 virus that causes COVID-19 while having less effect on animal skin cells compared to 270 nm UVC LEDs.

Sequana Medical NV reported positive results from the second interim analysis of its POSEIDON pivotal study evaluating the Alfapump for the treatment of recurrent or refractory ascites due to liver cirrhosis. These latest results, from 26 patients in the roll-in cohort, affirm earlier interim data showing high scores on all primary endpoints and continued improvement in quality of life.