Regulation

Omeros gets FDA Orphan Drug Designation for PNH therapy

Omeros has received orphan drug designation from the US Food and Drug Administration (FDA) for OMS906 to treat paroxysmal nocturnal hemoglobinuria (PNH).

QBiotics receives IND application approval for Phase II solid tumours therapy trial

The US Food and Drug Administration (FDA) has approved QBiotics Group’s Investigational New Drug (IND) application to commence the Phase II clinical trial (QB46C-H07) of tigilanol tiglate.

FDA grants fast track designation for Anthos’ cancer associated thrombosis therapy

The US Food and Drug Administration (FDA) has granted fast track designation for Anthos Therapeutics’ investigational Factor XI inhibitor, abelacimab, to treat thrombosis associated with cancer.

US FDA grants priority review to Eisai’s BLA for lecanemab

The US Food and Drug Administration (FDA) has granted priority review for Eisai’s biologics license application (BLA) under the accelerated approval pathway, for lecanemab to treat early Alzheimer’s Disease (AD)

Janssen secures FDA breakthrough designation for myeloma therapy

The Janssen Pharmaceutical Companies of Johnson & Johnson has received breakthrough therapy designation (BTD) from the US Food and Drug Administration (FDA) for talquetamab to treat relapsed or refractory multiple myeloma in adult patients.

Sanofi receives marketing authorisation from EC for Pompe disease therapy

Sanofi has received marketing authorisation from the European Commission (EC) for Nexviadyme (avalglucosidase alfa) to treat the complete spectrum of infantile-onset Pompe disease (IOPD) and late-onset Pompe disease (LOPD).

EMA’s CHMP recommends approval for AbbVie’s axial spondyloarthritis therapy

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of AbbVie’s Rinvoq (upadacitinib) to treat adult patients with active non-radiographic axial spondyloarthritis (nr‑axSpA).

EC approves Novartis’ Cosentyx to treat arthritis in children

The European Commission (EC) has approved the extended use of Novartis’ Cosentyx (secukinumab) to treat childhood arthritic conditions.

FDA accepts Emergent BioSolutions’ anthrax vaccine candidate for review

The US Food and Drug Administration (FDA) has agreed to review Emergent BioSolutions’ Biologics License Application (BLA) for AV7909 (Anthrax Vaccine Adsorbed, Adjuvanted).