BioCentury | Oct 8, 2020
Product Development

First patient dosed in Phase III hemophilia A trial could narrow gap between Pfizer/Sangamo and BioMarin

Pfizer and Sangamo dosed the first patient in their Phase III AFFINE study of giroctocogene fitelparvovec, and with the trial’s endpoint follow-up at 12 months, it could put the partners very close to the timing...
BioCentury | Dec 22, 2017
Clinical News

Kyowa's XLH candidate Crysvita gets nod from EMA's CHMP

EMA's CHMP recommended conditional approval of Crysvita burosumab (KRN23, UX023) from Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151) to treat X-linked hypophosphatemia (XLH) with radiographic evidence of bone disease in children ages one and up and...
BioCentury | Dec 15, 2017
Company News

CHMP recommends basket of therapies

EMA's CHMP recommended approval of a host of therapies, including Alofisel darvadstrocel (Cx601) to treat Crohn's disease, Ozempic semaglutide (NN9924, OG217SC) to treat Type II diabetes, Herzuma biosimilar trastuzumab to treat breast and gastric cancer...
BioCentury | Jul 29, 2013
Clinical News

TMA regulatory update

...for Rare Partners' 4,6,4'-trimethylangelicin (TMA) to treat cystic fibrosis (CF). The compound is in preclinical testing. Rare Partners s.r.l....
Items per page:
1 - 4 of 4
BioCentury | Oct 8, 2020
Product Development

First patient dosed in Phase III hemophilia A trial could narrow gap between Pfizer/Sangamo and BioMarin

Pfizer and Sangamo dosed the first patient in their Phase III AFFINE study of giroctocogene fitelparvovec, and with the trial’s endpoint follow-up at 12 months, it could put the partners very close to the timing...
BioCentury | Dec 22, 2017
Clinical News

Kyowa's XLH candidate Crysvita gets nod from EMA's CHMP

EMA's CHMP recommended conditional approval of Crysvita burosumab (KRN23, UX023) from Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151) to treat X-linked hypophosphatemia (XLH) with radiographic evidence of bone disease in children ages one and up and...
BioCentury | Dec 15, 2017
Company News

CHMP recommends basket of therapies

EMA's CHMP recommended approval of a host of therapies, including Alofisel darvadstrocel (Cx601) to treat Crohn's disease, Ozempic semaglutide (NN9924, OG217SC) to treat Type II diabetes, Herzuma biosimilar trastuzumab to treat breast and gastric cancer...
BioCentury | Jul 29, 2013
Clinical News

TMA regulatory update

...for Rare Partners' 4,6,4'-trimethylangelicin (TMA) to treat cystic fibrosis (CF). The compound is in preclinical testing. Rare Partners s.r.l....
Items per page:
1 - 4 of 4