23:56 , Sep 13, 2018 |  BC Extra  |  Company News

ICER panel: hATTR treatments have low value

The Institute for Clinical and Economic Review's Midwest Comparative Effectiveness Public Advisory Council (CEPAC) voted unanimously in separate tallies that the long-term value for money was low for hATTR treatments from Alnylam Pharmaceuticals Inc. (NASDAQ:ALNY)...
19:58 , Sep 7, 2018 |  BC Week In Review  |  Company News

Akcea cutting workforce by 10% after Waylivra CRL

Akcea Therapeutics Inc. (NASDAQ:AKCA) will reduce its workforce by about 10% following receipt of a complete response letter from FDA for Waylivra volanesorsen to treat familial chylomicronemia syndrome (FCS). Akcea announced the CRL on Aug....
18:50 , Aug 31, 2018 |  BC Week In Review  |  Clinical News

Onpattro approved in Europe as ICER says not cost-effective

The European Commission approved Onpattro patisiran from Alnylam Pharmaceuticals Inc. (NASDAQ:ALNY) for hereditary transthyretin (TTR)-mediated amyloidosis (hATTR) on Aug. 30, a day after the Institute for Clinical and Economic Review concluded the drug is not...
18:40 , Aug 31, 2018 |  BC Week In Review  |  Clinical News

Delay for Akcea's volanesorsen

Akcea Therapeutics Inc. (NASDAQ:AKCA) said it received a complete response letter for Waylivra volanesorsen to treat familial chylomicronemia syndrome (FCS), going against an FDA panel vote in May that backed approval of the compound. The company...
22:41 , Aug 30, 2018 |  BC Extra  |  Company News

Onpattro approved in Europe as ICER says not cost-effective

The European Commission approved Onpattro patisiran from Alnylam Pharmaceuticals Inc. (NASDAQ:ALNY) for hereditary transthyretin (TTR)-mediated amyloidosis (hATTR), a day after the Institute for Clinical and Economic Review concluded the drug is not cost-effective based on...
18:01 , Aug 28, 2018 |  BC Extra  |  Financial News

Akcea, Ionis tumble on volanesorsen setback

Akcea Therapeutics Inc. (NASDAQ:AKCA) and Ionis Pharmaceuticals Inc. (NASDAQ:IONS) each fell double-digits on Tuesday following a complete response letter from FDA for Waylivra volanesorsen. Akcea slid $8.39 (25%) to $24.73, while Ionis was down $8.53...
22:45 , Aug 27, 2018 |  BC Extra  |  Company News

Delay for Akcea's volanesorsen

Akcea Therapeutics Inc. (NASDAQ:AKCA) said it received a complete response letter for Waylivra volanesorsen to treat familial chylomicronemia syndrome (FCS), going against an FDA panel vote in May that backed approval of the compound. The company...
22:28 , Aug 27, 2018 |  BC Extra  |  Clinical News

Pfizer eyes submission after TTR readout; Alnylam gets bump

Pfizer Inc. (NYSE:PFE) reported detailed data from the Phase III ATTR-ACT trial of tafamidis meglumine in patients with transthyretin (TTR) cardiomyopathy showing that the drug led to a 30% improvement in all-cause mortality. However, investors...
01:59 , Aug 18, 2018 |  BioCentury  |  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...
18:37 , Aug 17, 2018 |  BC Week In Review  |  Clinical News

Alnylam gets first RNAi drug approval

Twenty years after the scientific co-founders of Alnylam Pharmaceuticals Inc. (NASDAQ:ALNY) discovered RNAi, a drug using the modality has been approved. On Aug. 10, FDA approved Onpattro patisiran to treat polyneuropathy caused by hereditary transthyretin...