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February 3, 2014
08:11 EDTPTLA, BAYRYPortola 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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April 17, 2014
15:05 EDTBAYRYBayer non-cystic fibrosis bronchiectasis treatment gets FDA orphan designation
According to a post on the FDA's website, Bayer's ciprofloxacin dry powder inhaler to treat non-cystic fibrosis bronchiectasis received orphan designation. Reference Link
April 14, 2014
08:12 EDTPTLAPortola announces publication of Phase 3 APEX study design, rationale
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April 10, 2014
07:24 EDTBAYRYInternational Society for Heart & Lung Transplantation to hold annual meeting
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April 9, 2014
07:09 EDTBAYRYReckitt Benckiser may be frontrunner for Merck unit, Bloomberg reports
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