It’s game day for bluebird bio. The company, battered by layoffs and cash concerns, faces a two-day crucible as the U.S. Food and Drug Administration’s Cell, Tissue and Gene Therapies Advisory Committee will give two lentiviral vector gene therapies a thumbs up or down.
Vertex Pharmaceuticals announced on Wednesday that the U.S. Food and Drug Administration granted Breakthrough Therapy Designation to the company’s candidate, inaxaplin (VX-147). Inaxaplin was granted the designation for the treatment of APOL1-mediated focal segment glomerulosclerosis (FSGS).
Bluebird bio’s blood disorder treatment demonstrates “clinically meaningful” benefit in patients, staff reviewers at the U.S. Food and Drug Administration said in briefing documents published on Tuesday.
Dublin, Ireland– April 30, 2015 – Shire plc (LSE: SHP, NASDAQ: SHPG) announces the appointment of Jeff Poulton as Chief Financial Officer (CFO) and member of the Executive Committee. Jeff will additionally join the Shire Board of Directors. Both appointments are effective immediately. Jeff has served as Interim CFO since December 2014, while overseeing Investor […]