00:06 , Apr 6, 2019 |  BioCentury  |  Finance

Big caps under pressure

Biogen’s fall in the wake of its decision to discontinue late-stage trials of Alzheimer’s therapy aducanumab is yet another reminder that large caps are in dire need of new pipeline products, and could serve as...
19:26 , Apr 5, 2019 |  BC Extra  |  Politics & Policy

DOJ releases details on biopharma settlements for alleged kickbacks to co-pay charities

Alexion has been added to the list of biopharma companies that have settled allegations of kickbacks to charitable patient assistance programs, according to a Department of Justice statement released Thursday. United Therapeutics Corp. (NASDAQ:UTHR), Actelion...
14:15 , Mar 20, 2019 |  BC Extra  |  Company News

Alexion augmenting pipeline with Zealand, Affibody deals

Alexion took a pair of steps toward further rebuilding its pipeline Wednesday, gaining rights to targets in the complement pathway via a deal with Zealand and adding a clinical-stage molecule from Affibody for IgG-mediated autoimmune...
18:14 , Feb 15, 2019 |  BC Week In Review  |  Company News

Samsung Bioepis partners with AffaMed, expands biosimilar development in China

Samsung Bioepis Co. Ltd. (Incheon, South Korea) partnered to develop four of its biosimilars with AffaMed Therapeutics (Shanghai, China). The partners will initially collaborate on clinical development, regulatory registration and commercialization Ontruzant, SB11, SB12 and...
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...
02:49 , Jan 5, 2019 |  BioCentury  |  Finance

Ready to launch

  The proposed $74 billion takeout of Celgene Corp. by Bristol-Myers Squibb Co. will not shift buysider attention away from upcoming and maturing drug launches heading into 2019, with plenty to track following a record...
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...