Another monoclonal antibody therapy has entered the pandemic fray with the FDA granting emergency use authorization (EUA) for bamlanivimab (LY-CoV555) 700 mg and etesevimab (JS016 or LY-CoV016) 1,400 mg as a cocktail for treating mild to moderate COVID-19 in patients aged 12 and up at high risk for progressing to severe COVID-19 and/or hospitalization.

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.

Preventive medicine hasn’t always had the backing of hard data, but research into genomics at the U.S. National Institutes of Health may soon change that. Evan Eichler of the Howard Hughes Medical Institute said on a recent NIH webinar that phased genome assembly may allow medical science to efficiently treat diseases caused by genetic disorders, but will also enable preventive medicine, the holy grail of those who seek to restrain the ever-increasing cost of medical care.

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.

Zimmer Biomet Holdings Inc. continued its transformation, disclosing Friday that it will spin off its spine and dental businesses into a separate, publicly traded company. The move will enable the independent company, identified as Newco, to pursue strategies and growth in spine and dental solutions that have not been a major focus for Zimmer Biomet, while allowing the latter to focus on high-growth orthopedic segments.

Novasignal Corp. has a launched a cloud-based app to provide alerts to clinicians directly from its cerebral ultrasound device. The new app allows physicians to get instant notifications from the company’s Novaguide device, a transcranial doppler ultrasound technology that allows for real-time assessment of blood flow in the brain by combining robotics and artificial intelligence (AI).

U.S. FDA warning letters have been a staple of regulatory life since the late 1990s, but James Boiani, a regulatory attorney with Epstein, Becker & Green P.C., said it’s no stretch of the imagination that warning letter volumes will jump in 2021. This is to some extent because the volume of warning letters dropped significantly over the past four years, and Boiani advised that all FDA-regulated industries will see more warning letters unless they are communicative with the agency about inspectional findings.

Becton, Dickinson and Co. (BD) reported revenue of $4.32 billion for the first quarter of fiscal year 2021, up 25.8% on a reported basis and 24.3% on a currency neutral basis. COVID-19 testing contributed 20.5% of that growth, totaling $867 million for the period, including $688 million in Veritor Plus system sales.

The U.S. FDA is still struggling to keep up with the volume of diagnostic emergency use authorizations (EUAs), but it is not for want of effort. Tim Stenzel, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health (OIR), said on the Feb. 3 testing town hall that the agency is processing nine such applications per day, a big jump over the rate of one per day in the early weeks of the COVID-19 pandemic.

While the Biden administration’s America Rescue Plan began its journey through Congress Feb. 3 as the next U.S. effort to address the COVID-19 pandemic, lawmakers came together to identify steps to improve vaccine distribution and curb ongoing supply shortages.