16:42 , Sep 21, 2018 |  BC Week In Review  |  Clinical News

BioCryst's oral HAE candidate reduces attack symptom severity in Phase II

BioCryst Pharmaceuticals Inc. (NASDAQ:BCRX) reported data from 33 evaluable patients treated for a total of 95 acute attacks of hereditary angioedema (HAE) in the Phase II ZENITH-1 trial showing that a single 750 mg dose...
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%)...
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...
23:43 , May 31, 2018 |  BC Innovations  |  Emerging Company Profile

Oral route for HAE

The team behind Firazyr icatibant has reunited to develop an oral version of the drug that could give hereditary angioedema patients the alternative to injectables they’ve been asking for. Pharvaris B.V. brings together team members responsible...
15:27 , May 25, 2018 |  BC Week In Review  |  Company News

Takeda divests stake in Chinese JV Techpool

Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) spokesperson Vince Docherty told BioCentury on May 23 that the pharma's divestment of critical care and API manufacturing JV Guangdong Techpool Bio-Pharma Co. Ltd. (Guangzhou, China) does not signal a...
22:34 , May 23, 2018 |  BC Extra  |  Company News

Takeda divests stake in Chinese JV

Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) spokesperson Vince Docherty told BioCentury on Wednesday that the pharma's divestment of critical care and API manufacturing JV Guangdong Techpool Bio-Pharma Co. Ltd. (Guangzhou, China) does not signal a strategic...
22:55 , May 11, 2018 |  BioCentury  |  Strategy

Takeda hits the gas

Takeda Pharmaceutical Co. Ltd.’s proposed acquisition of Shire plc is an acceleration of -- not a departure from -- CEO Christophe Weber’s stated strategy to build a top-tier global pharma, according to management. On May 8,...
21:10 , Apr 17, 2018 |  BC Innovations  |  Distillery Therapeutics

Ophthalmic disease

INDICATION: Diabetic macular edema (DME) In vitro, mouse and rat studies identified two bicyclic peptide inhibitors of KLKB1 that could help treat DME. Screening of a bicyclic peptide library in KLKB1 binding assays followed by optimization...