Regeneron will purchase Sanofi’s stake of cemiplimab (Libtayo) for $900 million in addition to royalties and other possible payments; a patient receives a 3D printed ear implant created using her own cells; the FDA accepts Pfizer’s EUA application for its COVID-19 vaccine for children aged younger than 5.
Regeneron Pharmaceuticals said it will purchase Sanofi's stake for $900 million in their cemiplimab (Libtayo) collaboration, the company said in a statement today. This purchase will grant Regeneron exclusive global development, commercialization, and manufacturing rights for cemiplimab, a PD-1 inhibitor approved for multiple cancers. In exchange, Sanofi will receive 11% in royalties and $100 million in a regulatory milestone payment upon FDA or European Commission approval, as well as up to $100 million in sales-related milestone payments for the next 2 years.
A 20-year-old woman has received a 3D printed ear implant created by 3DBio Therapeutics using her own cells, The New York Times reported. According to the regenerative medicine company, the woman was born with a small and misshapen right ear and the implant, which was transplanted in March, was printed to match her left ear and will continue to regenerate cartilage tissue to look and feel like a human ear. It is the first successful application of tissue engineering technology.
The FDA accepted Pfizer’s emergency use authorization (EUA) application for its COVID-19 vaccine for children aged younger than 5, ABC News reported. According to Pfizer, this vaccine is 80% effective against symptomatic COVID-19, but additional data may change this number. The FDA will hold a meeting with its advisory panel on June 15 to discuss the EUA requests from both Pfizer and Moderna for this age group. If authorized and agreed upon between the FDA and CDC advisory groups, COVID-19 vaccines for children aged younger than 5 may be available by the end of June.