Novo’s long-acting coagulation Factor IX showed polyethylene glycol (PEG) accumulation in the choroid plexus of animals, potentially raising a neurological safety issue when used in humans, FDA says ahead of Blood Products Advisory Committee review.

Biogen Idec will price its new hemophilia B drug Alprolix on par with older medicines like Pfizer’s Benefix on an annual basis despite the drug’s dosing advantage. The decision comes as high drug prices have come under increased scrutiny from payers and U.S. legislators.

Neither has announced a firm timeline, and the difference between Pfizer's 'October' and Moderna's 'November' could be mere hours or a few weeks, but Pfizer, by dint of luck or experience, is now in a position to offer the more optimistic projection on when it will seek an EUA. Both firms release their Phase III trial protocols, which seem in line with US FDA guidance.