BioCentury | Aug 11, 2020
Product Development

Remdesivir heads for FDA review as Gilead continues to build manufacturing pipeline

As Gilead continues to expand its manufacturing capabilities for Veklury, the company has moved a step closer to gaining full approval of the therapy in the U.S. for COVID-19. The company announced its NDA submission for...
BioCentury | Apr 1, 2020
Product Development

Chinese data propel InflaRx anti-complement mAb into clinic for severe COVID-19 pneumonia

Backed by preclinical and clinical data that support blocking complement to mitigate coronavirus-mediated respiratory distress, InflaRx has begun a clinical study of its own complement inhibitor to treat COVID-19 patients with severe pneumonia. InflaRx N.V....
BioCentury | Dec 4, 2019
Clinical News

Omeros’ narsoplimab headed for 1H20 submission on back of readout

Omeros is planning a follow-on offering and completion of a rolling BLA for narsoplimab after releasing the first set of pivotal data for the mAb to treat hematopoietic stem cell transplant-associated thrombotic microangiopathy, an Orphan...
BioCentury | Oct 5, 2018
Clinical News

Omeros' OMS721 underwhelms in Phase II for IgA nephropathy

Omeros Corp. (NASDAQ:OMER) reported data from nine evaluable steroid-free patients with IgA nephropathy in a Phase II trial showing that once-weekly IV OMS721 for 12 weeks led to a 0.4% greater reduction in median proteinuria...
BioCentury | Oct 2, 2018
Clinical News

Omeros' OMS721 underwhelms in Phase II

Shares of Omeros Corp. (NASDAQ:OMER) regained some ground Tuesday a day after the stock tumbled on data from nine evaluable steroid-free patients with IgA nephropathy in a Phase II trial showing that once-weekly IV OMS721...
BioCentury | Aug 3, 2018
Politics & Policy

ICER announces preliminary 2019 topics

The Institute for Clinical and Economic Review (ICER) released Thursday a preliminary list of drugs and other healthcare interventions that it may review in 2019. ICER's selection criteria include the projected timing and likelihood of...
BioCentury | Aug 2, 2018
Company News

Management tracks: Omeros, EdiGene

Omeros Corp. (NASDAQ:OMER) hired Eckhard Leifke as CMO and VP of clinical development. He was global project head/VP of early project and external opportunities - cardiovascular and metabolism and global head/VP of late-stage development diabetes at...
BioCentury | Mar 16, 2018
Clinical News

Omeros reports Phase II OS data for OMS721 in thrombotic microangiopathy

Omeros Corp. (NASDAQ:OMER) reported data from 18 patients with hematopoietic stem cell transplant (HSCT)-associated thrombotic microangiopathy (HCT-TMA) in a Phase II trial and one HCT-TMA patient treated under a compassionate use program showing that once-weekly...
BioCentury | Jan 5, 2018
Clinical News

Omeros to start Phase III trial of OMS721 to treat IgA nephropathy

Omeros Corp. (NASDAQ:OMER) said it reached an agreement with FDA on the design of a Phase III trial to test OMS721 in patients with IgA nephropathy. The company expects to begin enrollment early February. The...
BioCentury | Nov 10, 2017
Company News

Omeros soars on single Phase III plan for OMS721

Omeros Corp. (NASDAQ:OMER) soared $4.08 (29%) to $18.17 Friday after announcing late Thursday that FDA will accept a single Phase III trial with a primary endpoint of proteinuria reduction to support approval of OMS721 to...
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