Arcturus Therapeutics and CSL’s Kostaive COVID-19 vaccine approved in Europe
CSL (CSLLY) and Arcturus Therapeutics (ARCT) announced that the European Commission has granted marketing authorization for Kostaive, a ...
European Commission Approves CSL and Arcturus Therapeutics' KOSTAIVE®, the First Self-amplifying mRNA COVID-19 Vaccine
Global biotechnology leader CSL (ASX: CSL; USOTC: CSLLY) and sa-mRNA pioneer Arcturus Therapeutics (Nasdaq: ARCT) today ...
CSL, Arcturus Therapeutics announce European Commission approval for Kostaive
CSL (CSLLY) and Arcturus Therapeutics (ARCT) announced that the European Commission has granted marketing authorization for Kostaive, a ...
EU reshapes HTAs: is the industry ready for it?
New EU regulations aim to speed up health technology assessments (HTAs), but the pharma industry raises logistical concerns.
NL Times7h
Russian spies had access to EMA systems for four months in 2020 hack: report
Russian attackers were behind the hack of the European Medicines Agency EMA in 2020. They had “unauthorized access to ...
Gossamer Bio Is A Good Speculative Buy On Seralutinib For PAH And PH-ILD
Gossamer Bio's Seralutinib shows promise for PAH and PH-ILD treatment. The main event comes with its topline results in Q4 ...
EURACTIV19h
Czechia wants clear definition of patient groups in new EU pharma law
Czechia proposes changes that will better define the role of patient organisations when informing patients about therapeutic procedures without violating advertising regulations.
Pharm Exec23h
Navigating the EU’s Joint Clinical Assessment
Pathways to success for this key component of Europe’s new HTA regulation, where thinking beyond the purely technical will be ...
PipelineReview.com23h
European Commission Approves CSL’s ANDEMBRY® (garadacimab) for the Prevention of Recurrent Attacks of Hereditary Angioedema (HAE)
ANDEMBRY®, the first and only once-monthly treatment targeting factor XIIa to prevent attacks in HAE patients, inhibits plasma protein factor ...