Pfizer announces FDA and EMA acceptance of etrasimod regulatory submissions for ulcerative colitis
Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration (FDA) has accepted for review a New Drug Application (NDA) for etrasimod for individuals living with moderately-to-severely active ulcerative colitis (UC). The FDA's decision is expected in the second half of 2023. The European Medicines Agency (EMA) has also accepted the Marketing Authorization Application (MAA) for etrasimod in the same patient population with the decision anticipated in the first half of 2024. 
Asklepios BioPharmaceutical, Inc. (AskBio), a wholly-owned and independently-operated subsidiary of Bayer AG, today announced that the FDA's approval of a new adeno-associated virus (AAV) gene therapy to treat adults with hemophilia B marks another milestone for the advancement of AAV therapeutics and highlights the important research contributions made by AskBio Co-Founder, President and Chief Scientific Officer, R. Jude Samulski, PhD. 
Roche (SIX: RO, ROG; OTCQX: RHHBY) has entered into a U.S. focused collaboration with Pfizer to drive awareness and educate on the importance of timely COVID-19 testing, available treatment options, symptoms and the high-risk factors that can increase the chance of progressing to severe illness. 
GSK plc (LSE/NYSE: GSK) and Wave Life Sciences Ltd. (Nasdaq: WVE), a clinical-stage genetic medicines company committed to delivering life-changing treatments for people battling devastating diseases, today announced a strategic collaboration to advance oligonucleotide therapeutics, including Wave's preclinical RNA editing programme targeting alpha-1 antitrypsin deficiency (AATD), WVE-006.