01:55 , Oct 13, 2018 |  BioCentury  |  Product Development

Bourla’s breadcrumbs to value

Incoming CEO Albert Bourla has spent only a few of his 25 years at Pfizer Inc. in the pharma’s innovative drugs business, but there are signs he already has laid the groundwork for innovating how...
18:29 , Oct 12, 2018 |  BC Week In Review  |  Company News

ICER issues final report for hATTR therapies with recommendations

ICER released its final evidence report on treatments for hereditary transthyretin (TTR)-mediated amyloidosis (hATTR) recommending that insurers and payers develop prior authorization criteria for Onpattro patisiran and Tegsedi inotersen, and that manufacturers bring prices down...
18:09 , Oct 12, 2018 |  BC Week In Review  |  Clinical News

Akcea's AKCEA-APO(a)-LRx reduces LPA levels in Phase II

Akcea Therapeutics Inc. (NASDAQ:AKCA) said AKCEA-APO(a)-LRx led to significant dose-dependent reductions in lipoprotein(a) (LPA) compared with placebo in a Phase II trial to reduce elevated LPA levels in patients with established cardiovascular disease. The company...
17:27 , Oct 12, 2018 |  BC Week In Review  |  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...
21:55 , Oct 8, 2018 |  BC Extra  |  Company News

Management tracks: As Akcea shifts to commercialization, Crooke resigns from board

Akcea Therapeutics Inc. (NASDAQ:AKCA) said Stanley Crooke, founder, chairman and CEO of parent company Ionis Pharmaceuticals Inc. (NASDAQ:IONS), resigned from Akcea's board. Ionis CBO Damien McDevitt will take Crooke's place on Akcea's board. An Ionis...
01:14 , Oct 6, 2018 |  BioCentury  |  Finance

Large cap comeback

The biotech sector continued to be a stock pickers’ market through 3Q18 as there was a near even split between global biotech stocks that gained and lost value in the quarter. While 1H18 saw investors...
23:29 , Oct 5, 2018 |  BC Extra  |  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...
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...