17:25 , Sep 28, 2018 |  BC Week In Review  |  Clinical News

CHMP backs Luxturna, Lilly's migraine mAb, antibiotic Vabomere

EMA's CHMP on Sept. 21 recommended several therapies for approval, including gene therapy Luxturna voretigene neparvovec, migraine mAb Emgality galcanezumab and antibiotic Vabomere meropenem/vaborbactam. CHMP also confirmed its negative opinion for Exondys eteplirsen from Sarepta...
21:45 , Sep 21, 2018 |  BC Extra  |  Company News

CHMP backs Luxturna, Lilly's migraine mAb, antibiotic Vabomere

EMA's CHMP Friday recommended several therapies for approval, including gene therapy Luxturna voretigene neparvovec, migraine mAb Emgality galcanezumab and antibiotic Vabomere meropenem/vaborbactam. CHMP also confirmed its negative opinion for Exondys eteplirsen from Sarepta Therapeutics (NASDAQ:SRPT)...
19:19 , Aug 10, 2018 |  BC Week In Review  |  Clinical News

FDA approves Kyowa's Poteligeo for CTCL

FDA approved Poteligeo mogamulizumab-kpkc from Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151) to treat the two most common forms of cutaneous T cell lymphoma (CTCL). The agency approved Poteligeo to treat adults with relapsed or refractory...
18:31 , Aug 8, 2018 |  BC Extra  |  Company News

FDA approves Kyowa's Poteligeo for CTCL

FDA approved Poteligeo mogamulizumab-kpkc from Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151) to treat the two most common forms of cutaneous T cell lymphoma. The agency approved Poteligeo to treat adults with relapsed or refractory mycosis...
15:02 , Dec 22, 2017 |  BC Week In Review  |  Financial News

FLX Bio raises $60M series C

Cancer company FLX Bio Inc. (South San Francisco, Calif.) raised $60 million in a series C round from new investor GV (formerly Google Ventures) and existing investors The Column Group, Kleiner Perkins, Topspin Partners and...
13:52 , Dec 21, 2017 |  BC Extra  |  Financial News

FLX Bio raises $60M series C

Cancer company FLX Bio Inc. (South San Francisco, Calif.) raised $60 million in a series C round from new investor GV (formerly Google Ventures) and existing investors The Column Group, Kleiner Perkins, Topspin Partners and...
04:17 , Dec 15, 2017 |  BC Week In Review  |  Clinical News

Kyowa's Poteligeo meets in Phase III for CTCL

Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151) said Poteligeo mogamulizumab (AMG 761, KW-0761) met the primary endpoint of improving progression-free survival (PFS) in the Phase III MAVORIC trial to treat mycosis fungoides or Sézary syndrome, which...
20:06 , Dec 10, 2017 |  BC Extra  |  Clinical News

Kyowa's Poteligeo meets in Phase III for CTCL

Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151) said Poteligeo mogamulizumab (AMG 761, KW-0761) met the primary endpoint of improving progression-free survival (PFS) in the Phase III MAVORIC trial to treat mycosis fungoides or Sézary syndrome, which...
21:55 , Dec 1, 2017 |  BC Week In Review  |  Clinical News

Kyowa's mogamulizumab gets priority review for CTCL

FDA accepted and granted Priority Review to a BLA from Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151) for Poteligeo mogamulizumab (KW-0761, AMG 761) to treat cutaneous T cell lymphoma in patients who have received at least...
18:26 , Nov 28, 2017 |  BC Extra  |  Company News

Kyowa's mogamulizumab gets Priority Review for CTCL

FDA accepted and granted Priority Review to a BLA from Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151) for Poteligeo mogamulizumab (AMG 761, KW-0761) to treat cutaneous T cell lymphoma in patients who have received at least...