As the COVID-19 pandemic continues into the fall, Roche Group is planning to launch its latest tool later this month. And while its SARS-CoV-2 Rapid Antigen Test will be available in markets accepting the CE mark, the company is expecting the filing for emergency use authorization (EUA) from the U.S. FDA. Roche’s test is a rapid chromatographic immunoassay intended for the qualitative detection of a specific antigen of SARS-CoV-2 present in human nasopharynx.

The Court of Justice for the European Union (CJEU) has invalidated the EU-U.S. Privacy Shield, a mechanism designed to ensure the privacy of EU citizens’ data when conveyed to other nations in a manner consistent with the EU’s General Data Protection Regulation (GDPR). Makers of drugs and devices are not without recourse in transferring patient data to the U.S. for clinical trials conducted in Europe, but industry must revisit their standard contractual clauses to ensure those protocols provide the necessary privacy provisions, or face fines that could amount to tens of millions of euros.

LONDON – The U.K. is funding a national program of research to investigate the major unanswered questions related to the immune response to COVID-19. The aim of the research, involving teams of immunologists in 17 research institutions, is to unpick the immunological backdrop of one of the most notable aspects of COVID-19 infection, which is the huge spectrum of severity of symptoms.

Medtronic plc reported first-quarter worldwide revenue of just over $6.5 billion, a decrease of 13% as reported. As Cowen’s Josh Jennings wrote, the company’s results were better than expected, with an organic revenue growth decline of 17% vs. the Street’s prediction of a 25% decrease.

PARIS – Curadigm SAS has raised $1 million in non-dilutive funding from Bpifrance (Banque publique d’investissement in France), for development of its Nanoprimer technology. Bpifrance’s Deep Tech program in France recognizes health tech companies with breakthrough innovation and strong commercial potential.

LONDON – Biofidelity Ltd. has raised US$12 million in a series A, enabling it to start commercialization of a novel, low-cost, chemistry-based diagnostic for detecting all actionable lung cancer mutations. The Cambridge, U.K.-based company claims the test can detect a single molecule of mutated DNA against the background of billions of healthy molecules in a patient sample, without the need for DNA sequencing.

LONDON – European scale-up of an artificial intelligence tool for stratifying and personalizing treatment of COVID-19 patients according to the type of complications they are likely to experience will get underway in September, following initial validation. The tool, developed by researchers at the Hospital Clinic Barcelona, Spain, was ‘trained’ on more than a trillion anonymized data points retrieved from the clinic’s electronic health records system.

Advanced talks between the European Commission and Curevac AG have positioned the company to potentially supply up to 405 million doses of its investigational mRNA-based COVID-19 vaccine to the bloc. News of the progress, following similar EU-level talks with an alliance of Sanofi SA and Glaxosmithkline plc, Johnson & Johnson and Astrazeneca plc, sent Curevac's recently-listed U.S. shares (NASDAQ:CVAC) climbing 16% to $66 on Aug. 20.

Alcon AG released second-quarter results Aug. 18, reporting worldwide sales of $1.2 billion. That figure represented a decrease of 36%, or 34% on a constant currency basis, vs. the same period last year as COVID-19 hit all business categories. As Wells Fargo’s Larry Biegelsen noted, the Geneva-based company, which held its call Aug. 19, saw net loss per share coming in worse than expected due to higher selling, general and administrative expenses.

PARIS – Bellaseno GmbH recently completed a phase I trial of its Senella absorbable soft tissue reconstruction scaffold on an Australian patient with congenital pectus excavatum.