22:54 , Jan 15, 2019 |  BC Week In Review  |  Clinical News

FDA reviewing Pfizer's TTR amyloid cardiomyopathy therapy

Pfizer Inc. (NYSE:PFE) said FDA accepted for review two NDAs for tafamidis to treat transthyretin (TTR) amyloid cardiomyopathy based on two forms of the compound. The NDA for the tafamidis meglumine form was granted Priority...
20:28 , Jan 14, 2019 |  BC Extra  |  Company News

FDA reviewing Pfizer's TTR amyloid cardiomyopathy therapy

Pfizer Inc. (NYSE:PFE) said FDA accepted for review two NDAs for tafamidis to treat transthyretin (TTR) amyloid cardiomyopathy based on two forms of the compound. The NDA for the tafamidis meglumine form was granted Priority...
00:23 , Jan 12, 2019 |  BioCentury  |  Finance

We all fall down

After an exuberant third quarter that put biotech indexes near their 2015 highs, all market cap tiers fell in 4Q18, eliminating the first nine month's gains and losing $291.2 billion in aggregate value. Median losses...
02:49 , Jan 5, 2019 |  BioCentury  |  Finance

Ready to launch

  The proposed $74 billion takeout of Celgene Corp. by Bristol-Myers Squibb Co. will not shift buysider attention away from upcoming and maturing drug launches heading into 2019, with plenty to track following a record...
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...