As of Aug. 13, more than 90,000 patients hospitalized in the U.S. with COVID-19 already had been given access to convalescent plasma through a national expanded use protocol (EAP) sponsored by the Mayo Clinic. The FDA’s decision Sunday to grant emergency use authorization (EUA) for the potential therapy will further expand access to convalescent plasma for hospitalized patients throughout the country at a time when fully approved COVID-19 treatments are nonexistent and even EUAs are few and far between.

The U.S. Administrative Procedures Act (APA) has proven controversial for device makers in that the associated requirements for rulemaking have been the subject of regulatory end-runs, by some accounts. The Department of Justice (DOJ) said in an Aug. 11 statement, however, that it is time to update the APA because the it has ossified in the 74 years since passage, while an attached report estimated that government regulation adds as much as $2 trillion in compliance costs to the economy every year.

The COVID-19 pandemic has had an enormous impact on elective and nonessential procedures, and with them the medical device companies they depend on, but early signs of recovery are encouraging, according to Raghav Tangri, of (DRG), which is part of Clarivate. That said, Tangri told BioWorld that while the second quarter is expected to be the most strongly impacted period this year, the speed of recovery will depend on a number of factors, including the possibility of a second wave of the coronavirus outbreak and how soon a vaccine is available.

Avoiding the political overtones that seem to be more viral than COVID-19 these days, Anand Shah, deputy commissioner for medical and scientific affairs at the FDA, stressed that even though the agency is making decisions in real time in response to the urgency of the pandemic in the U.S., its decisions are being driven by scientific integrity, regulatory independence and the FDA’s historic commitment to ensuring the safety and efficacy of the products it regulates.

A Sino-U.S. collaborative study has demonstrated that acupuncture regulates inflammation by activating pro- or anti-inflammatory signaling pathways, while mitigating cytokine storms in mice with systemic inflammation, the study authors reported in the Aug. 12, 2020, edition of Neuron. The study also found that the acupuncture site, intensity and timing determined how it affected response, which has important implications for acupuncture use in inflammatory diseases and as adjunctive cancer therapy.

Life science companies doing business during a pandemic may believe that patients, judges and juries will look kindly on products that don’t perform as promised, but that may be an empty wish.

Two-and-a-half years after regenerative medicine company Mimedx Group Inc. came under federal investigation for improper sales and marketing practices and nearly two years since it was delisted by Nasdaq, the company is back on track financially and pursuing an active pipeline of new products. Marietta, Ga.-based Mimedx recently reported second quarter sales of $61.7 million, a 7.2% decline from the same period the prior year. The second quarter 10Q Form – one of seven SEC financial statements submitted in the last five months as the company worked to regain compliance – brings Mimedx up to date, paving the way for it to relist its stock.

Life science companies doing business during a pandemic may believe that patients, judges and juries will look kindly on products that don’t perform as promised, but that may be an empty wish. Angela Seaton, an attorney with the D.C. office of Shook, Hardy & Bacon LLP, advised that companies that want to break into new markets because of pandemic-specific demand should do their homework, including a review of U.S. FDA warning letters.

Transit Scientific LLC’s XO Cross Microcatheter platform was used in its first cases worldwide last week following its May 2020 clearance by the U.S. FDA and showed improved control and imaging. The company designed the platform to facilitate guidewire support, guidewire exchange, and contrast media injection during complex peripheral vascular interventions such as late-stage peripheral artery disease (PAD) and critical limb ischemia (CLI).