EuroBiotech Report—EMA-Brexit, Cell Medica CEO, ReViral, RedHill and Astex | Tech Science
Welcome to the latest edition of our weekly EuroBiotech Report. We start this week with the EMA, which warned that it may lose 30% of its staff in its move to Amsterdam. With the exodus already underway, the agency is cutting back on noncore activities. Cell Medica named the former head of Kite Pharma‘s European operations as its CEO. ReViral raised $55 million to advance its respiratory syncytial virus program. RedHill Biopharma’s phase 3 Crohn’s disease trial met its primary endpoint, only for the outcome to be overshadowed by waning efficacy later in the study. Guadecitabine, the drug Otsuka acquired in its takeover of Astex, fell short in phase 3. And more. — Nick Taylor
1. Brexit forces EMA to suspend tasks as job loss forecast jumps
The EMA is suffering heavier-than-expected job losses as a result of its relocation to the Netherlands, forcing it to scale back and suspend more of its activities. International collaborations, development of guidelines and other tasks will slow significantly as the EMA focuses its dwindling resources on key functions.
2. CAR-T player Cell Medica names Kite’s European chief as CEO
Cell Medica has appointed Chris Nowers as its CEO. Nowers joins the company from Gilead’s Kite Pharma at a time when Cell Medica is seeking to push CAR-T and TCR candidates through clinical development and on to the market.
3. ReViral raises $55M to run midphase RSV clinical trials
ReViral has raised $55 million (€47 million) to put a treatment for respiratory syncytial virus (RSV) infections through midphase trials. The series B round comes six months after ReViral completed a phase 2a evaluation of RSV fusion inhibitor RV521 in healthy volunteers.
4. RedHill’s RHB-104 hits primary endpoint in Crohn’s phase 3
A phase 3 trial of RedHill Biopharma’s Crohn’s disease asset has met its primary endpoint. The study linked antibiotic cocktail RHB-104 to a higher rate of remission than placebo after 26 weeks, although the difference between the two arms shrunk later in the trial.
5. Otsuka’s guadecitabine fails phase 3 AML trial
Otsuka’s guadecitabine has missed its coprimary endpoints in a phase 3 acute myeloid leukemia (AML) trial. The DNA hypomethylating agent failed to beat the complete response or overall survival rates achieved in the control arm, leaving Otsuka looking to ongoing trials in other indications to save the drug.
And more articles of note>>