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.
Biogen Idec Inc.'s immune modulator BG-12 (dimethyl fumarate) yielded better-than-expected top-line data in its first Phase III trial, news that bodes well for the Cambridge, Mass.-based firm's foray into the oral multiple sclerosis (MS) drug market and may help stave off competitive threats to its lucrative MS franchise.
