17:47 , Aug 3, 2018 |  BC Week In Review  |  Clinical News

Amgen's Blincyto among negative CHMP opinions

EMA's CHMP released a handful of negative opinions July 27, including one for Blincyto blinatumomab from Amgen Inc. (NASDAQ:AMGN) and, on re-examination, negative recommendations for Dexxience betrixaban from Portola Pharmaceuticals Inc. (NASDAQ:PTLA) and Eladynos abaloparatide-SC...
20:34 , Jul 27, 2018 |  BC Extra  |  Company News

New Blincyto indication among negative CHMP opinions

EMA's CHMP released a handful of negative opinions Friday, including one for Blincyto blinatumomab from Amgen Inc. (NASDAQ:AMGN) and, on re-examination, negative recommendations for Dexxience betrixaban from Portola Pharmaceuticals Inc. (NASDAQ:PTLA) and Eladynos abaloparatide-SC from...
20:03 , Jul 6, 2018 |  BioCentury  |  Emerging Company Profile

Tethering bleeding risk

With a mechanism that blocks thrombosis-contributing cells but not coagulation, Tetherex Pharmaceuticals Inc.’s pan-selectin inhibitor SelK2 could treat venous thromboembolism with little to no risk of bleeding. Chairman and CEO Scott Rollins said while antithrombotic drugs...
21:38 , Jun 7, 2018 |  BC Extra  |  Politics & Policy

CDER to resolve formal disputes at the center level

FDA Center for Drug Evaluation and Research Director Janet Woodcock said the Office of Executive Programs will now manage CDER's formal dispute resolution (FDR) program. The process allows sponsors of user fee drug and generics...
17:51 , May 11, 2018 |  BC Week In Review  |  Clinical News

FDA approves Portola's Andexxa

Portola Pharmaceuticals Inc. (NASDAQ:PTLA) added about $570 million in market cap on May 4 after FDA granted accelerated approval to a resubmitted BLA for its Andexxa andexanet alfa. The agency approved Andexxa to reverse the anticoagulant...
15:11 , May 4, 2018 |  BC Extra  |  Company News

Portola jumps on FDA approval of Andexxa

Portola Pharmaceuticals Inc. (NASDAQ:PTLA) gained $8.66 (26%) to $42.44 on Friday after FDA granted accelerated approval to a resubmitted BLA for its Andexxa andexanet alfa. Portola announced the approval after market close on Thursday. The agency...
21:06 , Apr 6, 2018 |  BioCentury  |  Finance

Smid-cap smorgasbord

While the biggest milestone of the second quarter came early and turned out to be a disappointment, investors still have plenty to look forward to in immuno-oncology. In addition, specialist investors’ current strategy of overweighting...
17:47 , Mar 30, 2018 |  BC Week In Review  |  Clinical News

Negative CHMP opinion for Portal VTE candidate

EMA's CHMP recommended against approval of Dexxience betrixaban from Portola Pharmaceuticals Inc. (NASDAQ:PTLA) to prevent venous thromboembolism (VTE) in adult patients hospitalized for an acute medical illness with risk factors for VTE, including VTE-related death....
21:59 , Mar 23, 2018 |  BC Extra  |  Company News

CHMP rebuffs Portola's betrixaban, Radius' abaloparatide-SC

EMA's CHMP issued negative opinions on Friday for Dexxience betrixaban from Portola Pharmaceuticals Inc. (NASDAQ:PTLA) and Eladynos abaloparatide-SC from Radius Health Inc. (NASDAQ:RDUS). The committee recommended against approval of Dexxience to prevent venous thromboembolism (VTE) in...
17:22 , Mar 23, 2018 |  BC Week In Review  |  Clinical News

Portola reports additional Phase IIIb/IV data of Factor Xa inhibitor antidote AndexXa

Portola Pharmaceuticals Inc. (NASDAQ:PTLA) reported data from 228 patients with Factor Xa inhibitor-associated acute major bleeding in the Phase IIIb/IV ANNEXA-4 trial showing that AndexXa andexanet alfa (IndexXa, PRT4445, PRT064445) led to “excellent or good”...