Five New EU Filings Leave Starting Blocks at EMA
Fast-Track Rejection For Amivantamab And Voxelotor
Executive Summary
There is one orphan drug among the five new marketing authorization applications that the European Medicines Agency has under review. All five drugs will be reviewed under standard review timelines.
You may also be interested in...
New Filings At The EMA
New medicines under evaluation at the European Medicines Agency.
Novo Nordisk Divides R&D, Expects More Late-Stage Studies In 2021
Novo Nordisk’s newer GLP1 products for diabetes, Ozempic and Rybelsus, drove the company’s sales growth in 2020, and with its CSO retiring after a two-decade shift, internal appointments are made to lead a reorganized R&D function.
Amgen Eschews Some Of Its BiTEs, But Otezla Spurs Growth
Without Otezla’s $2.2bn in 2020 sales, Amgen’s full-year revenue would have been slightly lower than in 2019, which is why all eyes are on the company’s R&D programs and near-term approvals.