Among the low-hanging fruit for pruning back U.S. drug prices is the development of generics referencing complex drugs, a category that includes drug-device combination products and nonbiologic drugs with a complex molecular base, route of administration or formulation, such as abuse-deterrent opioids.

The Biden administration said it will use the U.S. Defense Production Act to grapple with the COVID-19 pandemic in a plan that includes a large increase in vaccine purchases. Also on tap is an increase in production of at-home test by six companies in addition to Ellume Ltd., of Perth, Australia, which will ship more than 8 million of their tests to the U.S. by the end of the year.

The U.S. FDA granted de novo authorization for Signifier Medical Technologies LLC’s ExciteOSA, the first treatment for mild obstructive sleep apnea and snoring designed for daytime use. Used for 20 minutes a day, the device improves the function of the tongue muscle to prevent airway obstruction while sleeping. ExciteOSA, previously called Snoozeal, already has a CE mark.

The U.S. FDA granted 510(k) clearance for Clew Medical Ltd.’s artificial intelligence (AI)-based solution that can predict hemodynamic instability in ICU patients eight hours in advance of deterioration. The system continuously monitors and stratifies patients by risk level to enable optimization of ICU resources.