Andexanet Alfa (Andexxa ®): First Global Approval – first-in-class anticoagulant rescue for therapy-induced bleeding

Andexanet Alfa (Andexxa ®): First Global Approval – first-in-class anticoagulant rescue for therapy-induced bleeding

The recent first global approval of andexanet alfa [coagulation factor Xa (recombinant), inactivated-zhzo] has been reviewed in detail in the First Global Approval report in Adis’ journal Drugs[1], based on the development milestones tracked in AdisInsight[2]. Continue reading “Andexanet Alfa (Andexxa ®): First Global Approval – first-in-class anticoagulant rescue for therapy-induced bleeding”

Acalabrutinib (Calquence®): First Global Approval – Downstream approach dams the ability for tumour-survival in patients with mantle cell lymphoma

Acalabrutinib (Calquence®): First Global Approval – Downstream approach dams the ability for tumour-survival in patients with mantle cell lymphoma

The recent first global approval of acalabrutinib has been reviewed in detail in the First Global Approval report in Adis’ journal Drugs[1], based on the development milestones tracked in AdisInsight[2].

In October 2017, acalabrutinib (Calquence®), developed by Acerta Pharma, received its first global approval in the US for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. Continue reading “Acalabrutinib (Calquence®): First Global Approval – Downstream approach dams the ability for tumour-survival in patients with mantle cell lymphoma”