4D Pharma says the US Food and Drug Administration (FDA) has cleared its IND application for the first in-human trial to use Live Biotherapeutics (LBPs) for the treatment of Parkinson’s disease.
GlaxoSmithKline plc (GSK) says the US Food and Drug Administration (FDA) has approved its anti-IL-5 biologic Nucala (mepolizumab) in a 40 mg pre-filled syringe for children aged 6 to 11 years old with severe eosinophilic asthma (SEA).
Live biotherapeutic product (LBP) developer, 4D Pharma, which has been NASDAQ listed since March this year, has announced positive topline results for the first part of its Phase I/II trial of an LBP strain for the treatment of asthma.
AstraZeneca and Amgen’s Tezspire (tezepelumab-ekko) has been approved in the US for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma.
Dupixent, Regeneron and Sanofi’s collaborative mAb treatment for eczema, has been approved by the European Commission for a new indication in severe asthma.
Shire has acquired privately-held Meritage for an upfront fee of $70m and additional contingent payments based on the achievement of development and regulatory milestones.