22:14 , Nov 10, 2017 |  BC Extra  |  Company News

Management tracks: Immunomedics, WuXi

Antibody company Immunomedics Inc. (NASDAQ:IMMU) appointed Michael Pehl president and CEO, effective Dec. 7, and Brendan Delaney chief commercial officer. Interim CEO Michael Garone will resume his role as CFO. Pehl was president of hematology...
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,...
19:56 , Sep 1, 2017 |  BC Week In Review  |  Clinical News

FDA refuses NDA for SteadyMed's Trevyent

SteadyMed Ltd. (NASDAQ:STDY) said FDA issued a refusal to file letter to an NDA for Trevyent treprostinil to treat pulmonary arterial hypertension (PAH). FDA said the application was not complete and requested additional information on...
18:03 , Sep 1, 2017 |  BC Week In Review  |  Clinical News

FDA snubs Cardiome's Brinavess resubmission for AF

Cardiome Pharma Corp. (TSX:COM; NASDAQ:CRME) said FDA informed the company that its proposed data package for IV Brinavess vernakalant (Kynapid, MK-6621) to treat atrial fibrillation (AF) would not be sufficient to support resubmission of an...
21:17 , Aug 21, 2017 |  BC Extra  |  Company News

FDA snubs Brinavess resubmission for AF

Cardiome Pharma Corp. (TSX:COM; NASDAQ:CRME) said FDA informed the company that its proposed data package for IV Brinavess vernakalant to treat atrial fibrillation would not be sufficient to support resubmission of an NDA. On Monday,...
02:28 , Jul 13, 2017 |  BC Week In Review  |  Clinical News

SteadyMed submits NDA for Trevyent to treat PAH

SteadyMed Ltd. (NASDAQ:STDY) submitted an NDA to FDA for Trevyent treprostinil to treat pulmonary arterial hypertension (PAH). The company hopes to launch the candidate in mid-2018. SteadyMed partner Cardiome Pharma Corp. (TSX:COM; NASDAQ:CRME) said it...
23:50 , May 19, 2017 |  BC Extra  |  Company News

Management tracks

Spyros Artavanis-Tsakonas is no longer serving as CSO of Biogen Inc. (NASDAQ:BIIB), according to an SEC filing. He is now a visiting scientist, a part-time role. Artavanis-Tsakonas is a professor of cell biology at Harvard...
22:45 , Apr 7, 2017 |  BioCentury  |  Finance

To market, to market

Investors are hoping that a slew of approvals and data readouts can maintain biotech’s momentum on the heels of several high-profile successes that came just before or after 1Q’s end. Chief among those was Vertex...
00:53 , Dec 31, 2016 |  BioCentury  |  Finance

Delivering takeouts

  BioCentury’s 25th annual Buyside View finds biotech investors focusing on mid-cap names with late-stage or marketed products that could become M&A targets. “The main theme playing at the moment is investors like us are...
07:00 , Oct 3, 2016 |  BioCentury  |  Finance

Reasonable rally

Steve Edelson, Senior Editor   It looks like biotech's rebound will continue through the end of the year, but not with enough gusto to match the third quarter, or to make up for losses in...