With the lack of public trust and confidence the biggest barrier to SARS-CoV-2 vaccines in the U.S., the risk of granting an emergency use authorization to a vaccine with safety issues or questionable efficacy could destroy confidence in future FDA-approved products. That message was drummed home throughout the Oct. 22 meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee.

While the FDA’s approach to evaluating safety and efficacy in the development and review of COVID-19 vaccines for the U.S. market will be at the center of its Oct. 22 advisory committee meeting, the panel also will be asked to discuss the practicalities, and ethics, of continuing to conduct trials once a candidate has been granted an emergency use authorization.

The case of Arthrex v. Smith & Nephew at the U.S. Court of Appeals for the Federal Circuit was something of a nuclear option for the patent dispute at hand, as it raised a constitutional question regarding the appointment of administrative patent judges (APJ) at the Patent Trial and Appeal Board (PTAB). The Supreme Court has agreed to hear a consolidation of three petitions for cert arising from the Arthrex case, the outcome of which could force the reopening of a number of cases already decided by the PTAB.

Intervenn Biosciences said it has identified stark differences in the glycoproteomic profile of COVID-19 patients who became very sick and people infected with the SARS-CoV-2 virus who were either asymptomatic or experienced only minimal effects. The contrast could help clinicians better understand the biological mechanisms of the disease and triage patients at risk of responding detrimentally to early treatments and more intensive care.

Two teams of researchers have developed miniature models of the human heart that beat and function like the full-size organ.

As with many conferences, the Cleveland Clinic’s 2020 Medical Innovation Summit went virtual this year. Still, the event featured the hotly anticipated top 10 list of innovations for 2021 that saw a range of therapies. Ranked in order of expected importance, the list was led by gene therapy for hemoglobinopathies. The top three innovations, including a novel drug for primary-progressive multiple sclerosis and smartphone-connected pacemaker devices, were highlighted in a special presentation.

The annual med-tech conference hosted by the Advanced Medical Technology Association, always features an FDA town hall, but this year’s town hall labored under the overhang of the COVID-19 pandemic. Nonetheless, Jeff Shuren, director of the Center for Devices and Radiological Health (CDRH), repeatedly gave voice to frustration with the statutory authorities currently enjoyed by the center, stating on more than one occasion that the Medical Device Amendments of 1976 are more than 40 years old and are in need of updates to cope with modern medical technology.

In a fireside chat at the Advanced Medical Technology Association (Advamed)-sponsored Virtual Medtech Conference on Oct. 5, U.S. FDA Commissioner Stephen Hahn addressed questions that have been circulating for months about the political pressure that the agency is facing to quickly approve a vaccine for COVID-19 by reiterating that any decisions will be “completely dependent on when data is mature” from phase III trials.

The COVID-19 pandemic has done little to encourage bipartisan comity in Washington, and the Oct. 2 hearing of the House Select Subcommittee on the Coronavirus Crisis reflected that partisan tension. Secretary of Health and Human Services Alex Azar noted, however, that the department is doing its best to cooperate with oversight of the vaccine program by the Government Accountability Office (GAO), but that the nearly three dozen GAO requests for oversight have come at a difficult time.