19:08 , Jan 26, 2018 |  BC Extra  |  Company News

FDA approves Novartis' Lutathera for GEP-NETs

FDA approved Lutathera (177-Lu-Dotatate) from Novartis AG (NYSE:NVS; SIX:NOVN) to treat somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults, including foregut, midgut, and hindgut neuroendocrine tumors. Novartis gained the drug when it acquired Advanced Accelerator...
00:38 , Jan 6, 2018 |  BioCentury  |  Finance

Burgeoning bellwethers

  The miserable performance of large cap biotechs last quarter is likely to be a boon for small- and mid-cap players this year, in more ways than one. Buysiders spent most of 2017 focusing to a...
23:56 , Nov 3, 2017 |  BioCentury  |  Strategy

Broadening Novartis’ NET

Novartis AG’s proposed acquisition of Advanced Accelerator Applications S.A. would broaden the pharma’s neuroendocrine tumor franchise by providing it with a second-line agent -- Lutathera -- that addresses patients with progressive, symptomatic disease. On Oct. 30,...
04:51 , Nov 3, 2017 |  BC Week In Review  |  Company News

Novartis offers $3.9B to acquire Advanced Accelerator

Novartis AG (NYSE:NVS; SIX:NOVN) offered to acquire Advanced Accelerator Applications S.A. (NASDAQ:AAAP) for $82 per ADS in a deal the companies say values Advanced Accelerator at $3.9 billion. The price is a 12% premium on...
22:44 , Oct 30, 2017 |  BC Extra  |  Company News

Novartis offers $3.9B to acquire Advanced Accelerator

Novartis AG (NYSE:NVS; SIX:NOVN) offered to acquire Advanced Accelerator Applications S.A. (NASDAQ:AAAP) for $82 per ADS in a deal the companies say values Advanced Accelerator at $3.9 billion. The price is a 12% premium on...
23:52 , Oct 6, 2017 |  BioCentury  |  Finance

Bargain shopping

With all companies valued over $1 billion increasing a median of at least 16.8% in 1H17, investors went bargain shopping in the $500-$999 million tier in 3Q17. The group outperformed all other market cap bands,...
15:20 , Oct 6, 2017 |  BC Week In Review  |  Clinical News

EC approves Lutathera for GEP-NETs

The European Commission approved Lutathera (177-Lu-Dotatate, 177Lu-DOTA0-Tyr3-Octreotate, Lutetium Lu 177 Dotatate) from Advanced Accelerator Applications S.A. (NASDAQ:AAAP) to treat gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Specifically, the approval is for unresectable or metastatic, progressive, well-differentiated, somatostatin receptor-positive...
00:19 , Sep 30, 2017 |  BC Extra  |  Company News

EC approves Lutathera for GEP-NETs

The European Commission approved Lutathera (177-Lu-Dotatate) from Advanced Accelerator Applications S.A. (NASDAQ:AAAP) to treat gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Specifically, the approval is for unresectable or metastatic, progressive, well-differentiated, somatostatin receptor-positive GEP-NETs in adults. A resubmitted NDA...
19:56 , Sep 1, 2017 |  BC Week In Review  |  Clinical News

FDA accepts NDA for Advanced Accelerator's Lutathera

Advanced Accelerator Applications S.A. (NASDAQ:AAAP) said FDA accepted for review a resubmitted NDA for Lutathera (177-Lu-Dotatate, 177Lu-DOTA0-Tyr3-Octreotate, Lutetium Lu 177 Dotatate) to treat gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults. The PDUFA date is Jan. 26,...
22:10 , Aug 28, 2017 |  BC Extra  |  Company News

FDA accepts NDA for Lutathera

Advanced Accelerator Applications S.A. (NASDAQ:AAAP) said FDA accepted for review a resubmitted NDA for Lutathera (177-Lu-Dotatate) to treat gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults. The PDUFA date is Jan 26, 2018. FDA issued a complete response...