Blog
RSS FeedPosted by Michael Wonder on 16 Dec 2024
CHMP recommends approval of Galderma’s nemolizumab for moderate to severe atopic dermatitis and prurigo nodularis in the European Union
13 December 2024 - Nemolizumab is a first in class monoclonal antibody that specifically targets IL-31 receptor alpha, inhibiting the signaling ...
Posted by Michael Wonder on 16 Dec 2024
CSL receives positive CHMP opinion for garadacimab in hereditary angioedema
13 December 2024 - If approved, garadacimab will be the first and only once monthly treatment inhibiting factor XIIa to ...
Posted by Michael Wonder on 16 Dec 2024
Findings from the EUnetHTA 21 project for EU-HTA from 2025
12 December 2024 - The results from EUnetHTA 21 provide insights for future cooperation in EU-HTA: participants from IQWiG and ...
Posted by Michael Wonder on 16 Dec 2024
Celltrion receives positive CHMP opinion for three biosimilars in the European Union
15 December 2024 - The CHMP adopts positive opinions for Celltrion’s three biosimilar candidates – Eydenzelt (aflibercept), Stoboclo and Osenvelt (denosumab), ...
Posted by Michael Wonder on 16 Dec 2024
EMA’s CHMP recommends approval of Biocon Biologics’ Yesintek, biosimilar to J&J’s Stelara
15 December 2024 - Biocon Biologics today announced that the EMA’s CHMP has issued a positive opinion recommending approval of Yesintek, ...
Posted by Michael Wonder on 14 Dec 2024
First treatment for peripheral thyrotoxicosis in patients with Allan-Herndon-Dudley syndrome
13 December 2024 - Emcitate can be used in patients of all ages. ...
Posted by Michael Wonder on 14 Dec 2024
First treatment recommended for rare progressive lung conditions in children and adolescents
13 December 2024 - The EMA has recommended extending the indication of Ofev (nintedanib) to include the treatment of progressive ...
Posted by Michael Wonder on 14 Dec 2024
First medicine to treat rare genetic disorder causing cysts and tumours
13 December 2024 - Oral medicine to treat two different conditions, rare von Hippel-Lindau disease and advanced clear cell renal cell ...
Posted by Michael Wonder on 14 Dec 2024
Alofisel withdrawn from the EU market
13 December 2024 - Benefit of treatment used in Crohn’s disease no longer demonstrated. ...
Posted by Michael Wonder on 14 Dec 2024
Highlights from the 9-12 December 2024 CHMP meeting
13 December 2024 - The EMA’s CHMP recommended seventeen medicines for approval at its December 2024 meeting. ...
Posted by Michael Wonder on 14 Dec 2024
Roche’s Vabysmo pre-filled syringe approved in the EU for three retinal conditions that can cause blindness
13 December 2024 - Vabysmo PFS is the first and only pre-filled syringe containing a bi-specific antibody, offering a convenient alternative ...
Posted by Michael Wonder on 13 Dec 2024
Lilly's Omvoh (mirikizumab) recommended by CHMP for approval in the European Union for adults with moderately to severely active Crohn's disease
13 December 2024 - The Phase 3 VIVID-1 trial evaluated the safety and efficacy of Omvoh in patients with or without ...
Posted by Michael Wonder on 13 Dec 2024
Vir Biotechnology receives FDA breakthrough therapy designation and EMA PRIME designation for tobevibart and elebsiran in chronic hepatitis delta
12 December 2024 - Phase 3 ECLIPSE registrational program in chronic hepatitis delta to begin in the first half of 2025. ...
Posted by Michael Wonder on 10 Dec 2024
EMA publishes agenda for 9-12 December 2024 CHMP meeting
9 December 2024 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 10 Dec 2024
Chiesi Global Rare Diseases and Protalix BioTherapeutics announce validation of variation submission by EMA for pegunigalsidase alfa
9 December 2024 - Application to label a less frequent dosing regimen at a dose of 2 mg/kg body weight ...