Merck ($MRK) announced receiving the FDA approval for its biosimilar drug Renflexis, which is a second near-copy of Remicade. The drug is intended to be used for treating rheumatoid arthritis and other immune system disorders. Merck will market the drug and it is likely to be available in six months. The drug has been developed by Samsung Bioepis of South Korea.
Gilead Sciences reported results from two Phase 2 clinical trials assessing assessing it Harvoni (ledipasvir/sofosbuvir) in special patient populations. The results showed total and almost-total cure rates. One study, PS-101, in HCV-positive children aged 6 - 11, demonstrated a cure rate of 99% (n=89/90) while the other study, PS-098, in adults co-infected with HCV and HBV, showed a 100% (n=111/111) cure rate.