AstraZeneca Pharma India Limited has received permission to import pharmaceutical formulations of new drug for sale or for distribution in Form CT-20 from Central Drugs Standard Control Organisation for Palivizumab (Synagis) solution for injection 100 mg/ml (r-DNA origin) (50mg/0.5mL & 100 mg/mL presentations in single-dose vials administered through intramuscular route).
First, it was the CHMP. Then the European Commission, and as of Wednesday, the UK’s MHRA (but still no FDA).
On Friday, Enanta Pharmaceuticals showed that its experimental treatment, EDP-938, conferred a statistically significant reduction in the respiratory syncytial virus (RSV) viral load in healthy adults inoculated with the virus. Now comes the hard part.