Digital therapeutics have had a tough time gaining traction in the last few years. They’ve been hampered by sometimes reluctant payers, providers and regulators who lack familiarity with the approach, which typically employs an app or other technology to treat a patient by supporting behavioral adjustments.

PARIS – In the wake of the news that Swiss group Roche Holding AG received an emergency use authorization from the U.S. FDA as well as a CE-IVD certification for the Elecsys Anti-SARS-CoV-2 serology test to detect antibodies in people previously exposed to SARS-CoV-2 that causes the COVID-19 disease, the company unveiled its plans for the launch of the product.

Roche Holding AG, of Basel, Switzerland, has garnered U.S. FDA authorization for emergency use of a test to determine whether people have been infected with the novel coronavirus fueling the COVID-19 pandemic. The Swiss health care giant, which also makes molecular tests to detect active COVID-19 infection, claims its Elecsys Anti-SARS-CoV-2 antibody test accurately identifies COVID-19 antibodies in the blood 100% of the time, 14 days post-infection.

LONDON – In a potent demonstration of how COVID-19 is transforming the U.K. clinical trial landscape, 47,000 patients have been recruited to studies investigating potential treatments for the infection in a little over two months.

LONDON – The U.K. has started a fast track national trial of experimental drugs in COVID-19 patients, with Bergenbio ASA’s phase II cancer immunotherapy, bemcentinib, the first of six products that are due to join the study.

Arrakis Therapeutics Inc.’s CEO, Michael Gilman, knew his 3-year-old company had a partnering tiger by the tail just by the amount of interest from companies who wanted to partner. He sat back and waited until the right offer came along and went with Roche Holding AG. The result is a massive collaboration and license agreement that could stretch into the billions of dollars. “We very deliberately stayed out of partnering discussions for the first couple years,” Gilman told BioWorld. “It took a while to figure out how to do this. We wanted to understand what we had before selling off parts of it.”

PARIS – Europe has turned into the epicenter of the coronavirus pandemic, seeing more than 50% of the cases observed worldwide. In fact, whereas the COVID-19 pandemic has begun declining in China where it originated, there are 400,000 cases of coronavirus worldwide, including more than 200,000 infected by SARS-CoV-2 in the 55 sovereign states in continental Europe, where they are mourning more than 18,000 deaths.

DUBLIN – The Genentech arm of Roche Holding AG plans to move its interleukin-6 inhibitor, Actemra, into a global phase III trial in patients with severe pneumonia associated with COVID-19 infection.

DUBLIN – The Genentech arm of Basel, Switzerland-based Roche Holding AG plans to move its interleukin-6 (IL-6) inhibitor, Actemra (tocilizumab), into a global phase III trial in patients with severe pneumonia associated with COVID-19 infection.

The past week has seen a lot of movement in terms of tests to detect SARS-CoV-2, the virus that causes COVID-19. “It is notable that the diagnostics community is coming together in a way we have not seen in our 20 years covering this industry,” wrote William Blair analyst Brian Weinstein in a March 14 note. “Regulators, lab professionals, and manufacturers are all in a frenetic fury to try and get testing up and running, and we generally see a sense of ‘in it together’ playing out.”