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February 3, 2014
08:11 EDTBAYRY, PTLAPortola Pharmaceuticals enters into clinical collaboration agreement with Bayer
Portola Pharmaceuticals (PTLA) announced that it has entered into a second clinical collaboration agreement with Bayer HealthCare (BAYRY) and Janssen Pharmaceuticals to evaluate its investigational Factor Xa inhibitor reversal agent, andexanet alfa, in Phase 3 registration studies with the FDA-approved oral Factor Xa inhibitor XARELTO. Portola's original collaboration agreement with Bayer and Janssen, announced in February 2013, covered the conduct of a Phase 2 proof-of-concept study. Interim results of that study were presented in December 2013 at the 55th American Society of Hematology Annual Meeting and demonstrated that andexanet alfa can produce an immediate and dose-dependent reversal of the anticoagulation activity of XARELTO. The new clinical collaboration agreement will be in effect through completion of Phase 3 studies with XARELTO and any potential U.S. and EU regulatory approval of andexanet alfa. The Phase 3 studies are expected to start in the first half of 2014. Under this non-exclusive collaboration agreement, Portola will receive an upfront payment and is eligible to receive additional development and regulatory milestone payments. Portola retains full, worldwide commercial rights to andexanet alfa, which was designated as a breakthrough therapy by the FDA in November 2013 and for which Portola is pursuing an Accelerated Approval pathway.
News For PTLA;BAYRY From The Last 14 Days
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May 29, 2015
08:13 EDTPTLAPortola presents updated data from cerdulatinib Phase 1/2a study at ASCO
Portola Pharmaceuticals announced updated positive safety and efficacy data from the Phase 1 part of its ongoing Phase 1/2a proof-of-concept study of cerdulatinib in patients with hematologic cancers who have failed multiple therapies. Cerdulatinib is an oral, dual Syk-JAK kinase inhibitor that Portola is developing to treat patients with hematologic cancers, specifically those who have relapsed or who have not responded to prior therapies. The new data will be presented on Sunday, May 31, in a poster discussion session at the 2015 American Society of Clinical Oncology, or ASCO, Annual Meeting in Chicago. The company previously presented interim data from the Phase 1 part of the study at the American Society of Hematology, or ASH, 2014 Annual Meeting in December 2014. The results to be presented at ASCO demonstrated evidence of clinical activity in this study of patients with relapsed/refractory B-cell malignancies. To date, partial responses have been observed, including in patients with chronic lymphocytic leukemia, or CLL, follicular lymphoma, or FL, and transformed FL. Tumor reductions were seen in multiple patients, including those whose disease progressed on other BCR pathway inhibitors. Results also showed that cerdulatinib was well tolerated in these heavily pre-treated patients, with no dose-limiting toxicities identified. Grade 3/4 adverse events included fatigue. Dose-escalation is ongoing in the Phase 1 part of the study as the maximum tolerated dose has not yet been achieved.
07:06 EDTBAYRYAmerican Society of Clinical Oncology to hold annual meeting
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May 28, 2015
11:44 EDTPTLAPortola Pharmaceuticals management to meet with Maxim
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May 15, 2015
10:29 EDTBAYRYAmerican Urological Association to hold an annual meeting
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09:31 EDTBAYRYAmerican Thoracic Society to hold a conference
ATS 2015 Conference is being held in Denver on May 15-20.
07:26 EDTBAYRYBayer expecting crops and seeds industry consolidation, Reuters reports
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