Accelerated approval was considered as option in response to the negative advisory committee vote, but it was not a ‘default,’ CDER officials say. ‘It fit like a glove.’

As stakeholders begin to mull the impact of the Arthrex opinion, HHS withdraws its advisory opinion concluding manufacturers are legally bound to provide 340B discounts to contract pharmacies, and Lilly takes aim at 340b contract pharmacy ‘replenishment’ model.

Blackstone is providing $250m to combine Intellia’s gene editing and Cellex’s cell manufacturing capabilities in a new CAR-T company using Cellex subsidiary GEMoaB’s technology and pipeline as a foundation.

The FDA may want longer follow-up data for companies developing treatments for hemophilia A as well as hemophilia B.