BioCentury | Oct 12, 2018
Clinical News

FDA approves hereditary amyloidosis drug from Akcea, Ionis

Akcea Therapeutics Inc. (NASDAQ:AKCA) said FDA approved Tegsedi inotersen (IONIS-TTRRx) to treat polyneuropathy of hereditary transthyretin (TTR) amyloidosis (hATTR). Tegsedi's label includes a black box warning of increased risk for thrombocytopenia and glomerulonephritis. It also...
BioCentury | Oct 5, 2018
Company News

FDA approves hereditary amyloidosis drug from Akcea, Ionis

Akcea Therapeutics Inc. (NASDAQ:AKCA) said late Friday that FDA approved Tegsedi inotersen (IONIS-TTRRx) to treat polyneuropathy of hereditary transthyretin (TTR) amyloidosis (hATTR). Tegsedi's label includes a black box warning of increased risk for thrombocytopenia and...
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 | Apr 12, 2018
Translation in Brief

Viral variant vaccine

A team from Duke-NUS Medical School rapidly developed a live-attenuated Zika vaccine candidate by exploiting genetic errors to identify a strain with high viremia and reduced propagation. The approach could speed development of live vaccines...
BioCentury | Nov 9, 2017
Clinical News

Ionis reports updated Phase III data for inotersen in FAP

Ionis Pharmaceuticals Inc. (NASDAQ:IONS) reported updated data from the Phase III NEURO-TTR trial of inotersen (IONIS-TTRRx) in 172 patients with familial amyloidotic polyneuropathy (FAP), a form of transthyretin (TTR) amyloidosis. On the first co-primary endpoint,...
BioCentury | Nov 9, 2017
Clinical News

Alnylam, Sanofi report updated Phase III data for patisiran in FAP

Alnylam Pharmaceuticals Inc. (NASDAQ:ALNY) and the Sanofi Genzyme unit of Sanofi (Euronext:SAN; NYSE:SNY) reported updated data from the Phase III APOLLO trial of patisiran (ALN-TTR02) in 225 patients with familial amyloidotic polyneuropathy (FAP), a form...
BioCentury | Nov 2, 2017
Clinical News

Alnylam gains, Ionis down on updated data for ATTR candidates

Alnylam Pharmaceuticals Inc. (NASDAQ:ALNY) gained $12.50 (10%) to $133.59 on Thursday, while Ionis lost $5.94 (10%) to $51.82 after the companies reported detailed Phase III data for their candidates to treat familial amyloidotic polyneuropathy (FAP),...
BioCentury | Sep 29, 2017
Clinical News

Daiichi planning Japanese application for hypertension candidate

Daiichi Sankyo Co. Ltd. (Tokyo:4568) and Exelixis Inc. (NASDAQ:EXEL) said esaxerenone (CS-3150) met the primary endpoint in the Japanese Phase III ESAX-HTN trial to treat essential hypertension. In 1Q18, Daiichi plans to submit a regulatory...
BioCentury | Sep 29, 2017
Clinical News

Aptinyx starts Phase II trial of NYX-2925 to treat neuropathic pain

Aptinyx Inc. (Evanston, Ill.) began a Phase II trial of NYX-2925 to treat neuropathic pain associated with diabetic peripheral neuropathy. The double-blind, placebo-controlled, U.S. trial will evaluate multiple dose levels of once-daily NYX-2925 for 4...
BioCentury | Sep 25, 2017
Clinical News

Daiichi planning Japanese application for hypertension candidate

Daiichi Sankyo Co. Ltd. (Tokyo:4568) and Exelixis Inc. (NASDAQ:EXEL) said esaxerenone (CS-3150) met the primary endpoint in the Japanese Phase III ESAX-HTN trial to treat essential hypertension. In 1Q18, Daiichi plans to submit a regulatory...
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