FDA wants more data on AZ’s motavizumab

The FDA has asked AstraZeneca's (NYSE: AZN) MedImmune for more data on motavizumab, a monoclonal antibody being considered to help prevent serious respiratory syncytial virus. The disease is a major cause of lower respiratory tract infection and hospital visits in infants and children. In the complete response letter, the agency said it would need data from an additional trial of the drug to support a satisfactory risk/benefit profile for which the prophylaxis indication is being...

FDA delays decision on AZ’s motavizumab

AstraZeneca's (NYSE: AZN) MedImmune unit has received word from the FDA has delayed decision date for its review of motavizumab, an investigational monoclonal antibody being considered to help prevent serious respiratory syncytial virus, from June 24 to Aug. 27. AZ is hoping that the experimental drug, which had been in MedImmune's pipeline as a successor to Synagis, wins approval. But these hopes may be dashed, especially after a 14 to 3 vote by an FDA...

FDA panel rejects AZ’s new RSV drug in key setback

AstraZeneca's (NYSE: AZN) attempt to come up with a successor to its blockbuster RSV drug Synagis has run into some heavy flak, with an FDA panel turning their thumbs down on motavizumab in a lopsided vote. The experimental drug had been in MedImmune's pipeline as a successor to Synagis when AstraZeneca bought up the Maryland biotech three years ago. But by a vote of 14 to 3 the FDA experts raised a red flag on data linking motavizumab to a higher number of allergic reactions while criticizing...