EMA’s CHMP backs four new medicines in March

At its March meeting, EMA’s CHMP recommended four new medicines that were already approved by FDA, including three orphan medicines. Meanwhile, Vanda’s Hetlioz did not receive the same fate as it did in the U.S., as the committee deviated from FDA’s endorsement of the therapy for nighttime sleep disturbance in children with the rare indiction of Smith-Magenis syndrome.

Two of the orphan medicines backed by CHMP are for extensive-stage small cell lung cancer (ES-SCLC)...