Jan. 25 Quick Takes: Comirnaty approved in Australia, authorized in Hong Kong; plus Albireo, Iterum and AZ
Comirnaty (BNT162b2) from BioNTech SE (NASDAQ:BNTX) and Pfizer Inc. (NYSE:PFE) received provisional approval from the Australian Therapeutic Goods Administration and emergency use authorization from the Food and Health Bureau of the Hong Kong Special Administrative Region of the PRC. Shanghai Fosun Pharmaceutical Group Co. Ltd. (Shanghai:600196; HKEX:2196) and BioNTech announced in March a collaboration to work jointly on development and commercialization of COVID-19 vaccines in China.
FDA grants priority review to Albireo’s NDA for bile acid modulator
FDA granted priority review to an NDA for odevixibat from Albireo Pharma Inc. (NASDAQ:ALBO) to treat pruritus in patients with progressive familial intrahepatic cholestasis; the PDUFA date is July 20. Albireo also submitted an MAA to EMA for the SLC10A2 inhibitor in December. ...