BioCentury | Feb 11, 2020
Product Development

Adverum gains on Phase I data showing efficacy for wet AMD gene therapy

Updated interim data for Adverum’s intravitreal wet age-related macular degeneration gene therapy bolstered the company’s case that the product could compete with less convenient subretinal gene therapies for the indication. Adverum rose $1.81 (18%) to...
BioCentury | Oct 26, 2018
Politics & Policy

FDA grants first qualification of a clinical safety biomarker

FDA qualified a group of kidney injury biomarkers from the Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium (BC) and the Critical Path Institute (C-Path) Predictive Safety Testing Consortium (PSTC), marking the first...
BioCentury | Dec 31, 2016
Finance

SMA(ll) wonder

It’s a mystery why investors shaved 10% off gene therapy company AveXis Inc. (NASDAQ:AVXS) following FDA’s approval of Spinraza nusinersen for spinal muscular atrophy from Biogen Inc. (NASDAQ:BIIB) and Ionis Pharmaceuticals Inc. (NASDAQ:IONS). Spinraza has...
BioCentury | Feb 15, 2016
Clinical News

AKB-9778: Additional Phase IIa data

Additional data from the double-blind, U.S. Phase IIa TIME-2 trial in 144 patients with DME showed that twice-daily 15 mg subcutaneous AKB-9778 with and without once-monthly Lucentis ranibizumab led to a >=2-step improvement on the...
BioCentury | Feb 1, 2016
Clinical News

Pyridoxamine: Phase III ongoing

NephroGenex said an independent DSMB recommended continuation of the double-blind, placebo-controlled, international Phase III PYR-311 trial evaluating 300 mg oral Pyridorin twice daily until ESRD or death occurs. The trial, which has an SPA from...
BioCentury | Dec 21, 2015
Clinical News

Masitinib: Completed Phase III enrollment

AB Science completed enrollment of 381 patients in a double-blind, placebo-controlled, European Phase III trial of oral masitinib plus riluzole. AB Science S.A. (Euronext:AB), Paris, France Product: Masitinib ( Masican ) ( AB1010 ) Business: Neurology Molecular target: Stem...
BioCentury | Jul 20, 2015
Clinical News

AKB-9778: Phase IIa data

Top-line data from the double-blind, U.S. Phase IIa TIME-2 trial in 144 patients showed that twice-daily 15 mg subcutaneous AKB-9778 plus once-monthly Lucentis ranibizumab significantly reduced CST from baseline to 3 months, the primary endpoint,...
BioCentury | Jul 16, 2015
Clinical News

Aerpio combo tops Lucentis alone in DME study

Aerpio Therapeutics Inc. (Cincinnati, Ohio) said a combination of its AKB-9778 and Lucentis ranibizumab was superior to Lucentis alone in the Phase IIa TIME-2 study to treat diabetic macular edema (DME). The combination met the...
BioCentury | Mar 16, 2015
Clinical News

AKB-9778: Additional Phase Ib/IIa data

Additional data from the open-label, dose-escalation, U.S. Phase Ib/IIa TIME-1 trial in 18 evaluable patients with DME showed that twice-daily subcutaneous AKB-9778 at doses of >=15 mg for 28 days improved BCVA by >=5 letters...
BioCentury | Mar 2, 2015
Clinical News

Astragraf XL tacrolimus: Phase IIIb data

The open-label, international Phase IIIb DIAMOND trial in 893 patients showed that once-daily low-dose (0.15-0.175 mg/kg) Advagraf in combination with Simulect basiliximab and mycophenolate mofetil (MMF) met the primary endpoint of increasing GFR as measured...
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