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...
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...
01:23 , Mar 31, 2018 |  BioCentury  |  Strategy

Refashioning Takeda

Takeda Pharmaceutical Co. Ltd.’s potential acquisition of Shire plc appears to be timed to take advantage of the chance to acquire products and a global footprint on the cheap. The combination would create a global biopharma...
21:02 , Mar 2, 2018 |  BC Week In Review  |  Clinical News

Priority review for Shire's HAE prophylactic

FDA accepted and granted Priority Review to a BLA for lanadelumab (SHP643) from Shire plc (LSE:SHP; NASDAQ:SHPG) to prevent hereditary angioedema (HAE) attacks in patients ages 12 and older. Its PDUFA date is Aug. 26. The...
22:09 , Feb 23, 2018 |  BC Extra  |  Company News

Priority Review for Shire's HAE prophylactic

FDA accepted and granted Priority Review to a BLA for lanadelumab (SHP643) from Shire plc (LSE:SHP; NASDAQ:SHPG) to prevent hereditary angioedema (HAE) attacks in patients ages 12 and older. Its PDUFA date is Aug. 26. The...