The FDA has authorized its third antigen test for the novel coronavirus, designed to provide fast and cost-efficient results at the point of care and in community settings.

Bayer will pay about $1.6 billion to settle nearly all of the U.S. lawsuits that, over several years, have claimed the company’s Essure birth control implant caused serious injuries.

Generating insulin-producing pancreatic beta cells from stem cells to replace those that have been destroyed by the immune system is a promising approach to treating diabetes. But it has proven challenging to make the cells responsive to glucose changes and to prevent an immune attack after the cells are transplanted.

Qiagen launched new tools to capture and track emerging mutations in the novel coronavirus, which can lead to new strains that may change how the world responds to the COVID-19 pandemic.

Alzheon has been trying to go public for years, calling off its IPO in April 2018 and aborting its second attempt in January last year. Now, public markets be damned, the company is moving forward with a phase 3 study of its lead Alzheimer’s disease program thanks to a $47 million grant from the National Institutes of Health’s National Institute on Aging (NIA).

Since launching a study to see whether its wearable activity trackers could pick up on the early signs of a COVID-19 infection, Fitbit has enrolled over 100,000 participants across the U.S. and Canada and is now delivering its first, preliminary results 90 days later.

MOBILion Systems aims to make mass spectrometry analyses even more accurate and to give the biopharma industry a leg up in identifying previously undetected molecules and proteins as therapeutic targets as well as new biomarkers for diagnostic work.

The FDA has flagged two issues with Thermo Fisher Scientific’s molecular diagnostic for COVID-19 that could lead to inaccurate results.

Last year, Albireo CEO Ron Cooper painted elobixibat, a drug approved in Japan for constipation, as one arm of a two-pronged strategy to fight fatty liver disease. Now, the company is down to one prong, as the program failed to move the needle on nonalcoholic steatohepatitis (NASH) and nonalcoholic fatty liver disease (NAFLD) in a phase 2 study.

BioMarin’s shares plummeted in early Wednesday trading after the FDA refused to approve its hemophilia A gene therapy valoctocogene roxaparvovec.