The FDA has undertaken several measures to make the regulatory process less burdensome for diagnostics companies, but these may not be enough to incentivize companies to take their new genetic tests through the approval process. At the same time, confusion reigns: a special HHS advisory committee on genetic testing has been disbanded, and the FDA is reviewing its jurisdiction to regulate home brews, which are the dominant route to commercialization for genetic tests. Some critics worry that these developments may stifle innovation and companies are waiting for clarity.

The largest shareholder in major Japanese pharma firm Taisho, the founding Uehara family, intends to smooth the way to the restructuring and expansion of the business by acquiring and delisting all of its stock. The nearly $5bn size of the deal would makes it the biggest management buyout in Japanese corporate history.

Biden administration’s new framework will consider whether a product’s price is reasonable in deciding whether to exercise march-in rights. Numerous other factors could limit provision’s impact, but industry is concerned it will discourage firms from licensing government-funded inventions.