01:13 , Feb 1, 2019 |  BC Week In Review  |  Clinical News

Phase III data augur label expansion for Alexion's Ultomiris

Alexion Pharmaceuticals Inc. (NASDAQ:ALXN) plans to submit new data to regulatory authorities that could expand the label of long-acting complement 5 (C5) inhibitor Ultomiris ravulizumab-cwvz to include atypical hemolytic uremic syndrome (aHUS). Alexion said that...
13:26 , Jan 30, 2019 |  BC Innovations  |  Distillery Therapeutics

Neurology; cardiovascular

INDICATION: Alzheimer's disease (AD); atherosclerosis Mouse studies suggest inhibiting C5 could help treat AD and atherosclerosis. In a transgenic mouse model of AD expressing mutant human amyloid precursor protein (APP) and presenilin 1 (PSEN1; PS1),...
17:47 , Jan 28, 2019 |  BC Extra  |  Clinical News

Phase III data augur label expansion for Alexion's Ultomiris

Alexion Pharmaceuticals Inc. (NASDAQ:ALXN) plans to submit new data to regulatory authorities that could expand the label of long-acting complement 5 (C5) inhibitor Ultomiris ravulizumab-cwvz to include atypical hemolytic uremic syndrome (aHUS). Alexion said Monday...
19:07 , Jan 4, 2019 |  BC Week In Review  |  Clinical News

Viela planning BLA submission for inebilizumab in rare CNS disorder

Viela Bio Inc. (Gaithersburg, Md.) said it will submit a BLA to FDA this half for inebilizumab (MEDI-551) to treat neuromyelitis optica spectrum disorder (NMOSD) after the compound met the primary endpoint in the Phase...
01:29 , Jan 4, 2019 |  BC Week In Review  |  Clinical News

Alexion gains early approval for long-acting PNH therapy

Alexion Pharmaceuticals Inc. (NASDAQ:ALXN) received FDA approval for Ultomiris ravulizumab-cwvz (ALXN1210), the biotech's long-acting formulation of Soliris eculizumab, to treat paroxysmal nocturnal hemoglobinuria. While the approval came nearly two months ahead of the Feb. 18...
12:06 , Jan 3, 2019 |  BC Extra  |  Clinical News

Viela planning BLA submission for inebilizumab in rare CNS disorder

Viela Bio Inc. (Gaithersburg, Md.) said it will submit a BLA to FDA this half for inebilizumab (MEDI-551) to treat neuromyelitis optica spectrum disorder (NMOSD) after the compound met the primary endpoint in the Phase...
23:31 , Dec 21, 2018 |  BC Extra  |  Company News

Alexion gains early approval for long-acting PNH therapy

Alexion Pharmaceuticals Inc. (NASDAQ:ALXN) received FDA approval for Ultomiris ravulizumab-cwvz (ALXN1210), the biotech's long-acting formulation of Soliris eculizumab, to treat paroxysmal nocturnal hemoglobinuria. While the approval came nearly two months ahead of the Feb. 18...
19:26 , Dec 21, 2018 |  BC Week In Review  |  Clinical News

Chugai's IL-6 receptor mAb meets in Phase III for rare CNS disorder

Chugai Pharmaceutical Co. Ltd. (Tokyo:4519) said satralizumab (SA237, RG6168) as monotherapy met the primary endpoint in the Phase III SAkuraStar trial to treat neuromyelitis optica spectrum disorder (NMOSD). The company plans to submit regulatory applications...
19:21 , Dec 21, 2018 |  BC Week In Review  |  Clinical News

Roche, Chugai PNH candidate well tolerated in Phase I/II

Chugai Pharmaceutical Co. Ltd. (Tokyo:4519) said SKY59 (RG6107; RO7112689) was well tolerated with no treatment-related serious adverse events reported in patients with paroxysmal nocturnal hemoglobinuria (PNH) who received the humanized mAb targeting complement 5 (C5)...
21:23 , Dec 19, 2018 |  BC Extra  |  Clinical News

Chugai's IL-6 receptor mAb meets in Phase III for rare CNS disorder

Chugai Pharmaceutical Co. Ltd. (Tokyo:4519) said satralizumab (SA237, RG6168) as monotherapy met the primary endpoint in the Phase III SAkuraStar trial to treat neuromyelitis optica spectrum disorder (NMOSD). The company plans to submit regulatory applications...