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) for...
18:24 , Aug 31, 2018 |  BC Week In Review  |  Clinical News

Kyowa's KW-6356 improves motor symptoms in Phase IIa for early PD

Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151) said low- and high-dose oral KW-6356 both improved motor symptoms compared with placebo in a Phase IIa trial in 168 patients with early Parkinson's disease who had not received...
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 mycosis...
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 fungoides...
17:53 , Aug 3, 2018 |  BC Week In Review  |  Company News

Kyowa, Ultragenyx sell Priority Review voucher for $80.6M

Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151) revealed that it and partner Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) sold a rare pediatric disease Priority Review voucher during 2Q18 to an undisclosed company for $80.6 million. Ultragenyx spokesperson Danielle Keatley...
17:06 , Aug 3, 2018 |  BC Week In Review  |  Clinical News

CHMP positive on patisiran, Symkevi, Humira and Neulasta biosimilars

EMA's CHMP recommended a number of approvals July 26, including Onpattro patisiran from Alnylam Pharmaceuticals Inc. (NASDAQ:ALNY), Symkevi tezacaftor/ivacaftor from Vertex Pharmaceuticals Inc. (NASDAQ:VRTX), a handful of cancer therapies and three biosimilars. The committee recommended approval...
17:45 , Jul 31, 2018 |  BC Extra  |  Company News

Kyowa, Ultragenyx sell Priority Review voucher for $80.6M

Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151) revealed that it and partner Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) sold a rare pediatric disease Priority Review voucher during 2Q18 to an undisclosed company for $80.6 million. Ultragenyx spokesperson Danielle Keatley...
22:08 , Jul 27, 2018 |  BC Extra  |  Company News

CHMP positive on patisiran, Symkevi, Humira and Neulasta biosimilars

EMA's CHMP recommended a number of approvals Friday, including Onpattro patisiran from Alnylam Pharmaceuticals Inc. (NASDAQ:ALNY), Symkevi tezacaftor/ivacaftor from Vertex Pharmaceuticals Inc. (NASDAQ:VRTX), a handful of cancer therapies and three biosimilars. The committee recommended approval of...
20:06 , Jul 27, 2018 |  BioCentury  |  Finance

Earnings on deck

Earnings on deck At least 16 profitable biotechs and pharmas are slated to report earnings this week. (A) Fiscal 1Q; (B) Fiscal 3Q; (C) During trading hours in Europe; premarket on U.S. exchanges; (D) Six-month EPS CompanyDatePre/post...
03:05 , Jun 30, 2018 |  BioCentury  |  Finance

Hidden in the rough

Judicious stock picking was especially important in the second quarter, as 57% of global biotech stocks saw their equity values decline. Volatility continued to roil global markets during the period and additional uncertainty looms with the...