Novartis, MedImmune cite FDA vaccine hurdles

Novartis AG (NYSE:NVS; SIX:NOVN) and AstraZeneca plc (LSE:AZN; NYSE:AZN) subsidiary MedImmune said on Wednesday that FDA regulatory requirements have prevented them from introducing influenza vaccine technologies in the U.S. that are used in Europe. Speaking at a congressional hearing, Vas Narasimhan, president of Novartis Vaccines, USA, said the company submitted an IND for adjuvanted influenza vaccine in 2008 and expected to submit a BLA based on clinical data that supported its EMEA approval. Novartis is not currently pursuing the application because FDA is requiring new clinical studies conducted under FDA oversight, Narasimhan said. ...