03:45 , Apr 13, 2018 |  BC Innovations  |  Targets & Mechanisms

Meeting the burden

A major theme at this year’s AACR is the abundance of preclinical discovery driven by molecular signatures in patient samples, suggesting the research community is heeding the call for studies better grounded in human data,...
20:18 , Feb 23, 2018 |  BC Week In Review  |  Clinical News

Portola expects CHMP to recommend andexanet alfa, but not betrixaban

Portola Pharmaceuticals Inc. (NASDAQ:PTLA) said EMA's CHMP communicated a "positive trend vote" for an MAA for AndexXa andexanet alfa (IndexXa, PRT4445, PRT064445) to reverse the anticoagulant effects of Factor Xa inhibitors. However, Portola said the...
16:21 , Dec 15, 2017 |  BC Week In Review  |  Clinical News

CHMP requests more information on betrixaban VTE MAA

Portola Pharmaceuticals Inc. (NASDAQ:PTLA) said EMA’s CHMP requested additional information related to its MAA for betrixaban (PRT054021) for extended-duration prophylaxis of venous thromboembolism (VTE) in adults with acute medical illness and risk factors for VTE....
04:00 , Oct 28, 2017 |  BioCentury  |  Product Development

Chinks in the armor

Even with slowing revenues tied largely to a single product and a dearth of launches, Wall Street darling Celgene Corp. had been on an extended tear, growing its share price in excess of 300% since...
19:46 , Jul 5, 2017 |  BC Week In Review  |  Clinical News

FDA approves Portola's Bevyxxa betrixaban to prevent VTE

FDA approved an NDA from Portola Pharmaceuticals Inc. (NASDAQ:PTLA) for Bevyxxa betrixaban (PRT054021) to prevent venous thromboembolism (VTE) in hospitalized and post-discharge adults with acute illnesses who are at high risk for complications. The oral...
19:14 , Jun 23, 2017 |  BC Extra  |  Company News

Portola soars after FDA approves anticoagulant Bevyxxa

Portola Pharmaceuticals Inc. (NASDAQ:PTLA) jumped $17.81 (47%) to $56.06 on Friday after FDA approved Bevyxxa betrixaban to prevent venous thromboembolism (VTE) in hospitalized and post-discharge adults with acute illnesses who are at high risk for...
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...
19:55 , Mar 14, 2017 |  BC Week In Review  |  Clinical News

Vorolanib: Completed Ph II APEX Study enrollment

Tyrogenex completed enrollment of 157 patients previously treated with an anti-VEGF drug in the double-blind, placebo-controlled, international Phase II APEX Study evaluating 50, 100 and 200 mg oral vorolanib once daily for 52 weeks plus...
21:53 , Feb 9, 2017 |  BC Week In Review  |  Clinical News

Betrixaban regulatory update

Portola said FDA does not plan to hold an advisory committee meeting to discuss an NDA for the company's betrixaban. The agency did not identify any issues during its mid-cycle review that require a meeting,...
16:24 , Feb 8, 2017 |  BC Extra  |  Company News

Portola: FDA won't require betrixaban meeting

Portola Pharmaceuticals Inc. (NASDAQ:PTLA) said FDA does not plan to hold an advisory committee meeting to discuss an NDA for the company's betrixaban ( PRT054021 ). The agency did not identify any issues during its...