This week, the DC Attorney General announced a settlement with ovulation-tracking app Premom; a novel scoliosis treatment won FDA approval; research showed Fractyl Health’s Rejuva delivery system can deliver gene therapy directly to the pancreas; and BearCare recalled a thermometer over burn risks.

Japan's SCARDA is building networks with academia and industry to support new vaccine development, while offering support through funding and knowledge. But is that enough to overcome the shortcomings highlighted by the pandemic?

Agency did not intend to ‘strong-arm or threaten’ anyone in its duty to disclose notice, patent office legal advisors say. Applicants should assess whether information required by FDA on new method of manufacturing or different formulation impacts patentability.

Genentech claims Biogen and Millennium owe royalties on sales of Tysabri and Entyvio that were stockpiled when the Cabilly patent expired. Hospira faced similar litigation over its erythropoietin biosimilar and had to pay Amgen $70m in damages.