16:26 , Sep 21, 2018 |  BC Week In Review  |  Clinical News

FDA wants extra trial for Pharming's Ruconest as HAE Prophylactic

Pharming Group N.V. (Euronext:PHARM) said FDA requested another clinical trial of Ruconest conestat alfa as a prophylactic for hereditary angioedema in a complete response letter for an sBLA in the indication. Pharming, which fell €0.20 (20%)...
18:24 , Sep 19, 2018 |  BC Extra  |  Company News

FDA wants extra trial for Pharming's Ruconest as HAE prophylactic

Pharming Group N.V. (Euronext:PHARM) said FDA requested another clinical trial of Ruconest conestat alfa as a prophylactic for hereditary angioedema in a complete response letter for an sBLA in the indication. Pharming, which fell €0.20 (20%)...
21:52 , Sep 18, 2018 |  BC Extra  |  Company News

Management tracks: BioTime, Immune-Onc

Degenerative disease company BioTime Inc. (NYSE-A:BTX; Tel Aviv:BTX) named Brian Culley CEO, to replace co-CEOs Adi Mohanty and Michael West. Most recently, Culley was CEO of infectious disease company Artemis Therapeutics Inc. (OTCQB:ATMS). Immunotherapy company Immune-Onc...
17:27 , Sep 14, 2018 |  BC Week In Review  |  Company News

Takeda to move U.S. headquarters to Boston area

Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) will move its U.S. headquarters from Deerfield, Ill., to a to-be-determined site in the greater Boston area after its planned acquisition of Shire plc (LSE:SHP; NASDAQ:SHPG) closes next half. Takeda spokesperson...
05:06 , Sep 12, 2018 |  BC Extra  |  Company News

Takeda to move U.S. headquarters to Boston

Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) will move its U.S. headquarters from Deerfield, Ill., to a to-be-determined site in the greater Boston area after its planned acquisition of Shire plc (LSE:SHP; NASDAQ:SHPG) closes next half. Takeda spokesperson...
18:41 , Aug 31, 2018 |  BC Week In Review  |  Clinical News

FDA approves Shire's Takhzyro, first mAb to prevent HAE

Shire plc (LSE:SHP; NASDAQ:SHPG) said FDA approved Takhzyro lanadelumab-flyo to prevent attacks of hereditary angioedema in patients ages 12 and older. The company said Takhzyro is the first mAb approved in the U.S. to prevent...
23:16 , Aug 23, 2018 |  BC Extra  |  Company News

FDA approves Shire’s Takhzyro, first mAb to prevent HAE

Shire plc (LSE:SHP; NASDAQ:SHPG) said FDA approved Takhzyro lanadelumab-flyo to prevent attacks of hereditary angioedema in patients ages 12 and older. The company said Takhzyro is the first mAb approved in the U.S. to prevent...
01:59 , Aug 18, 2018 |  BioCentury  |  Product Development

Agreement to differ

FDA’s approval of Alnylam’s Onpattro marks the start of a showdown in the Orphan disease hATTR amyloidosis, with Akcea’s Tegsedi likely coming to the U.S. market in less than two months. Alnylam has used its...
20:34 , Aug 17, 2018 |  BC Extra  |  Politics & Policy

China unveils cancer drugs for medical insurance access negotiation

China's State Medical Insurance Administration announced 18 cancer drugs that will be included in 2018 medical insurance access negotiations. Companies with drugs on the list will now enter into negotiations to include the drugs on...
00:52 , Aug 17, 2018 |  BC Innovations  |  Targets & Mechanisms

RNA party

A study in Cell has uncovered a brain regulatory network involving a circular RNA, a long non-coding RNA and two microRNAs, and could provide some much needed insights in a field where finding links to...