Almost exactly a year after Dendreon Corp. set the prostate cancer space abuzz with the approval of immunotherapy Provenge (sipuleucel-T), Centocor Ortho Biotech Inc. scored another win with an FDA nod for abiraterone, an oral androgen biosynthesis inhibitor, roughly two months ahead of schedule.
In less than two months, Fibrocell Sciences Inc.'s LaViv (azficel-T) could become the second FDA-approved autologous cell therapy, following Dendreon Corp.'s prostate cancer vaccine Provenge (sipuleucel-T) last year. But the Exton, Pa.-based biotech isn't aiming for the medical market.
How does a big pharma firm ensure that early stage research in the hot area of autoimmune diseases doesn't get lost amid expanding late-stage pipelines?
In less than two months, Fibrocell Sciences Inc.'s LaViv (azficel-T) could become the second FDA-approved autologous cell therapy, following Dendreon Corp.'s prostate cancer vaccine Provenge (sipuleucel-T) last year. But the Exton, Pa.-based biotech isn't aiming for the medical market.
Amarin Corp. plc's purified EPA omega-3 fatty acid compound AMR101 bested investor expectations in a second Phase III study, sending the Dublin, Ireland-based firm's shares soaring 95 percent Monday and potentially catapulted the drug into a multi-billion-market opportunity.
Bydureon watchers finally got some good news, as the European Committee for Medicinal Products for Human Use (CHMP) voted in favor of the once-weekly version of glucagon-like peptide-1 agonist exenatide in Type II diabetes, all but ensuring the drug's final approval overseas.
