18:37 , Apr 4, 2019 |  BC Extra  |  Company News

Management tracks: Gottlieb's next move, plus Vertex, Centogene and more

FDA Commissioner Scott Gottlieb will return to the American Enterprise Institute as a resident fellow after he leaves the agency. His last day at FDA is Friday. Gottlieb expects to work part-time at AEI, where...
01:03 , Jan 12, 2019 |  BioCentury  |  Finance

Warning: cash needed

  A near decade-long run of cheap money appears to be coming to a close, and most of the biotech sector isn’t well positioned for the new reality. BioCentury’s analysis shows that two-thirds of biotech...
20:50 , Dec 19, 2018 |  BC Innovations  |  Distillery Therapeutics

Hematology

INDICATION: Bleeding In vitro and human plasma studies identified a peptide-based plasmin inhibitor that could help treat bleeding. Chemical synthesis and in vitro testing of analogs of a sunflower cyclic peptide serine protease inhibitor in...
20:24 , Oct 5, 2018 |  BC Week In Review  |  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...
23:38 , Oct 2, 2018 |  BC Extra  |  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...
23:21 , Sep 10, 2018 |  BC Extra  |  Company News

Management tracks: PolarityTE, Medivir

Regenerative biomaterial company PolarityTE Inc. (NASDAQ:COOL) terminated Chief Investment Officer and EVP John Stetson on Friday after the Securities and Exchanges Commission filed charges against him alleging his involvement in "pump-and-dump" schemes (see "Opko's Frost...
22:10 , Aug 3, 2018 |  BC Extra  |  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...
21:08 , Aug 2, 2018 |  BC Extra  |  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...
22:46 , Mar 22, 2018 |  BC Extra  |  Company News

An omnibus win for Omeros

A provision in the proposed omnibus appropriations bill approved Thursday by the House of Representatives may offer Omeros Corp. (NASDAQ:OMER) a lifeline for its struggling cataract surgery drug Omidria phenylephrine/ketorolac, sending the company's stock up...
16:13 , Mar 16, 2018 |  BC Week In Review  |  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...