Is it an unconstitutional taking when U.S. FDA reviewers disclose a brand company’s claimed trade secrets or confidential commercial information to would-be competitors? That’s a question the U.S. Court of Federal Claims has yet to answer. While the court dismissed some of Vanda Pharmaceuticals Inc.’s claims against the FDA, its Jan. 18 opinion left open the debate of whether such disclosures, intentional or inadvertent, are a per se or regulatory taking.

Invitae Corp. continued its aggressive cost-cutting initiative with the sale of its reproductive health assets to Natera Inc. for $10 million in upfront cash and an additional $42.5 million in potential milestone payments and litigation credits. The assets include screening tests for carrier status and non-invasive prenatal screening.

The U.S. Congress has passed a continuing resolution (CR) for the fiscal 2024 budget, an exercise that has become all too common as a substitute for a full suite of spending bills in an era of growing deficits.

Genotype assay testing can detect new variants of the COVID-19 virus six days faster than whole genome sequencing (WGS), with results returned in just three days — compared to nine for WGS — according to a study published in the Lancet Microbe.

One of the more significant enforcement actions to date in 2024 is the $13 million hit taken by the owner of a clinical lab in New Jersey for allegations of payment of kickbacks for unnecessary testing, suggesting that this new year will be a robust one for federal fraud enforcement in the U.S.