Articles related to DEVICE/DRUG APPROVALS

The decision was based on the findings of the open-label, multi-cohort, multicenter, phase 1b/2 clinical trial EV-103/KEYNOTE-869. Patients who participated in the study and were included in the current analysis had locally advanced or metastatic disease, were ineligible for cisplatin-containing chemotherapy, and had not previously received systemic therapy. The primary efficacy outcome measures for the study were the objective response rate (ORR) and duration of response (DoR), which were determined by an independent central review using RECIST v1.1. The ORR for the 121 patients treated with the combination was 68%, with 12% having a complete response. The median DoR for dose escalation was 22 months for two cohorts but not for a third.

According to the FDA, more than 101,000 fatal overdoses were reported during the 12-month period that ended in October 2022. Nearly half of fatal overdoses involve bystanders, but naloxone is only used in a small percentage of those situations. According to medical professionals who support the approval, there would be a critical opportunity to close this gap and lower the number of opioid-related deaths if naloxone were available over-the-counter.

The article reports that a new blood test, called the EasyM protocol, has been certified by the US Food and Drug Administration (FDA) for use in detecting multiple myeloma relapse. The test works by detecting small amounts of circulating tumor DNA (ctDNA) in the blood, which can indicate the presence of residual disease. The EasyM protocol is reportedly more sensitive than existing tests for detecting ctDNA, and can provide results in just a few hours. The article notes that the test has the potential to improve patient outcomes by allowing for earlier detection of relapse and more personalized treatment options.

The Abbott Alinity I TBI test is a laboratory-based test that measures ubiquitin C-terminal hydrolase L1 (UCH-L1) and glial fibrillary acidic protein, two biomarkers in the blood that have been linked to brain injury when present in high concentrations. The test has a sensitivity of 96.7% and a negative predictive value of 99.4%. The availability of a blood test provides clinicians with an objective method to quickly evaluate patients with mTBIs while eliminating the need for a head CT scan, potentially reducing health care costs and minimizing emergency department wait times.

The Nerivio device is worn on the arm and uses painless electrical stimulation to activate peripheral nerves, thereby inducing a conditioned pain modulation response. It is controlled by a smartphone app and is recommended to be used every other day for migraine prevention.

The every-other-month intra-ocular injection shows a reduction in lesion growth that increases over time. The ocular formulation of the drug, previously approved for paroxysmal nocturnal hemoglobinuria, should be available in specialty pharmacies in March 2023.