The problem of patent subject matter eligibility is still a nightmare for companies in the diagnostics space, but patent attorney Michael Borella said this is still an issue for software as well. Borella said there are three characteristics that should be considered while drafting patent claims – specificity, technical character and novelty – to arrive at a reasonable assurance that that the key claims in a patent application will survive a challenge in hazardous legal environs, such as the Court of Appeals for the Federal Circuit.

Tonix Pharmaceuticals Holding Corp. is looking to lessons from tuberculosis and smallpox to guide its future in infectious diseases. The company is developing an intradermal skin test like that used for TB to measure T-cell immunity to SARS-CoV-2, the virus that causes COVID-19. It also has three vaccines in development for COVID-19 that rely on horsepox, likely the form of vaccinia used by Edward Jenner to create the smallpox vaccine.

The U.S. House Energy and Commerce Committee needed two days of hearings to get through a spending measure that provided the FDA with $500 million for its part in the government response. The CDC would receive $7.5 billion for vaccine distribution and tracking, all developments that ran parallel to an announcement that another 200 million doses of vaccine will be delivered by the end of July at a cost of $3.7 billion.

Laboratory Corporation of America Holdings (Labcorp) reported its financial performance for the fourth quarter of 2020, which included a jump in revenues of 52%, a result enabled in part by its quick response to the COVID-19 pandemic. However, Labcorp said that revenues related to pandemic testing could decline by anywhere from 35% to 50% over the course of calendar year 2021.

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.