BioCentury | Aug 18, 2018
Product Development

Agreement to differ

FDA’s approval of Alnylam’s Onpattro marks the start of a showdown in the Orphan disease hATTR amyloidosis, with Akcea’s Tegsedi likely coming to the U.S. market in less than two months. Alnylam has used its...
BioCentury | Dec 5, 2017
Distillery Therapeutics

Hematology

INDICATION: Hemophilia Cell culture and mouse studies suggest an engineered mutant Factor VIIa/Tissue Factor complex could help treat hemophilia A. The mutant complex consisted of Factor VIIa and soluble TF harboring Q64C and G109C mutations,...
BioCentury | Sep 19, 2016
Clinical News

Spiriva Respimat tiotropium bromide: Phase III data

Top-line data from the double-blind, international Phase III CanoTinA-asthma trial in 401 patients ages 6-11 with moderate symptomatic asthma who were taking an inhaled corticosteroid with or without another controller medication showed that once-daily 2.5...
BioCentury | Mar 26, 2015
Company News

FDA approves Eylea for diabetic retinopathy

FDA approved Eylea aflibercept from Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) to treat diabetic retinopathy in patients with diabetic macular edema (DME). The human fusion protein that binds all forms of VEGF-A and placental growth factor ( PGF...
BioCentury | Mar 2, 2015
Clinical News

Spiriva Respimat tiotropium bromide: Phase III data

The MezzoTinA-asthma trials are part of the Phase III UniTinA-asthma program, which is evaluating Spiriva Respimat in over 6,000 patients with different asthma severities who remain symptomatic on ICS. The product is under review in...
BioCentury | Sep 10, 2012
Clinical News

Spiriva Respimat Soft Mist tiotropium: Phase III data

Data from the pair of identical double-blind, international Phase III PrimoTinA-asthma trials in 912 patients with severe persistent asthma showed that 5 µg twice-daily tiotropium as add-on therapy to usual care met the co-primary endpoints...
BioCentury | Jun 18, 2012
Clinical News

Spiriva Respimat tiotropium: Phase II data

A double-blind, crossover, international Phase II trial in 105 patients aged 12-17 with symptomatic, moderate persistent asthma who were receiving inhaled corticosteroids (ICS) with or without long-acting beta agonists (LABA) or leukotriene receptor antagonists showed...
BioCentury | Dec 22, 2008
Clinical News

Xencor preclinical data

Data from cynomolgus monkeys showed that XmAb5574 was well tolerated and elicited immediate and sustained B cell depletion in a dose-dependent manner. The humanized mAb, which targets the CD19 antigen with affinity for Fc gamma...
BioCentury | Aug 25, 2008
Clinical News

M2e: Phase I data

A double-blind, dose-escalating Phase I trial in 60 healthy volunteers showed that M2e was well tolerated and demonstrated immunogenicity at 0.3 µg dose. Subjects received 2 doses of 0.3, 1, 3 and 10 µg 28...
BioCentury | Sep 23, 2002
Finance

Ebb & Flow

Investors voted with their feet after learning that they will have to wait even longer for regulatory clarity over competing compounds for Fabry disease from Genzyme (GENZ) and Transkaryotic (TKTX). On Friday, the FDA postponed...
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