Genetically modified T-cell therapy granted enhanced EMA regulatory pathway: KTE-C19

Kite Pharma granted access to PRIME regulatory support for KTE-C19 to treat chemorefractory DLBCL In a press release, Kite Pharma announced that it is?among first sponsors selected to participate in the EMAs enhanced regulatory program for investigational therapies that promise significant advances against serious diseases. ?The?European Medicines Agency (EMA) Committee for Medicinal Products for Human[…]

Pipeline biosimilar for asthma meets primary endpoint in P2/3 study

In Brief Biosimilar News reports that Sorrento’s experimental anti-IgE biosimilar, STI-004, met it’s primary endpoint in a 32-week, Phase 2/3 study conducted in China. ?Patients who received?STI-004 experienced?asthma exacerbation at a lower rate than those who received placebo: ?21% vs?55%. According to the Sorrento press release, the patient population included both?adult and adolescents suffering from[…]

Patients who participate in clinical trials – insights into their thinking and desires

Interviews by Marie Lux give great insights on patients: How they think and what they really want. #3sixtypharmaSME? ?What patients really want https://twitter.com/3SixtyPharma/status/734089140237656064