The FDA posted a recall of a vaporizer unit that is used in several anesthesia gas machines distributed by Getinge USA Sales LLC, of Wayne, N.J., an issue that has triggered eight complaints. While no injuries or deaths have been reported, this is a class I recall due to the prospect that the problem can trigger irritation of the lung as well as pulmonary edema.

The U.S. NIH said it will go to court if necessary to defend its role in developing Moderna Inc.’s COVID-19 vaccine. NIH spokeswoman Renate Myles told BioWorld that the agency “is not giving up on our claim that NIH is a co-inventor on the mRNA technology used in the Moderna’s COVID-19 vaccine but defers to legal authorities on how this might be resolved.”

Targeting the thousands of rare inherited diseases that have no treatments in the U.S., a newly launched public-private group plans to pursue efforts to optimize and streamline the gene therapy development process.

The U.S. National Institutes of Health reported Oct. 14 that it has awarded contracts in the amount of $77.7 million for development and manufacture of a dozen new rapid tests for the SARS-CoV-2 virus. The monies were awarded under the NIH’s Rapid Development of Diagnostics (RADx) program, and will add seven viral antigen detection and five viral RNA detection tests to the suite of offerings. all with an eye toward more rapid turn-around of test results. The news of the new round of RADx grants was followed by 24 hours the announcement that the Department of Health and Human Services has extended the public health emergency (PHE) for the COVID-19 pandemic for another three months.

Francis Collins, perhaps one of the U.S.’ biggest cheerleaders for the promise of medical science, announced Oct. 5 that he will be ending his nearly 13-year tenure as NIH director by the end of the year, but he won’t be hanging up his lab coat. The 71-year-old Collins will continue to lead his research lab at the NIH’s National Human Genome Research Institute.

The U.S. National Institutes of Health had its hands full with the Rapid Acceleration of Diagnostics (RADx) program as the COVID-19 pandemic unwound, but the agency’s other work on diagnostics is bearing fruit. NIH said Aug. 31 that its collaboration with an academic research institute has led to development of a test that predicts which patients suffering from neurofibromatosis will develop cancers with metastatic potential.

Eclipse Regenesis Inc. received a National Institutes of Health fast track grant of $1.7 million to advance development of the Eclipse Xl1 system for short bowel syndrome. The spring-like Eclipse device harnesses mechanotransduction to stimulate growth of new, functional intestinal tissue. Short bowel syndrome is a devastating and rare condition that leads sufferers with too little small intestine to extract sufficient nutrients to sustain life. The grant for Menlo Park, Calif.-based Eclipse came through NIH’s small business innovation program.

The U.S. National Institutes of Health (NIH) said it has developed a novel method of sample preparation for tests for the SARS-CoV-2 virus, which could trim time and costs for diagnostic testing for COVID-19. This approach bypasses the RNA extraction step, thus eliminating the need for some supplies, and NIH said this technique is available for co-development or licensing with the private sector, giving the smart testing company access to a patent-protected technology with an existing demand already built in.

The U.S. National Institutes of Health (NIH) has waded into the controversial question of the respective roles of rapid antigen and polymerase chain reaction (PCR) tests for detection of the SARS-CoV-2 virus, a question that roiled relations between the FDA and public health experts. According to NIH, three rapid antigen tests administered at three-day intervals offer the same level of sensitivity as PCR, a finding that will likely make itself felt in future communicable disease outbreaks.