Portola plans to resubmit the crucial BLA for its anticoagulant reversal agent AndexXa 'in the second quarter of 2017' after its unexpected August CRL. An approval would shore up the commercial success of Xarelto and Eliquis. Meanwhile, it has filed an NDA for its own Factor Xa inhibitor, betrixaban.
Portola Pharmaceuticals Inc. suffered a surprise setback in August this year when its reversal agent AndexXa (andexanet) was the subject of a complete response letter from the US FDA. (Also see "Portola Seeks Narrower Label For AndexXa Antidote After FDA Rebuff" - Scrip, 19 August, 2016.)
Portola was hoping to secure approval for its reversing effects to the Factor Xa inhibitors Johnson & Johnson/Bayer...
A disastrous Phase II miss for the pulmonary arterial hypertension candidate AV-101 leaves Aerovate drifting. Could Gossamer stand to benefit?
2030 sales forecasts for Novo’s obesity hope are an order of magnitude larger than its closest rival among 2025’s expected debutantes.
GLP-1 receptor agonists could play a big role in tackling neurodegeneration and a new academic study has raised expectations of Novo Nordisk’s latest semaglutide Phase III results
CEO Bill Anderson would not be drawn on whether the drug, currently approved for chronic kidney disease associated with type 2 diabetes, will hit a previous forecast of €3bn peak sales, but expansion into heart failure may make that figure look conservative.
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Pipelines in bioconjugates continue to develop, from ADCs to XDCs, with radionuclide drug conjugates (RDCs) and antibody-oligonucleotide conjugates (AOCs) leading the expansion.
Interim results from the Phase III REMARK study presented at WCLC showed the Chinese company’s second-generation ALK/ROS1 inhibitor met its primary endpoint as a first-line therapy in ALK-positive advanced NSCLC.
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