Blog
RSS FeedPosted by Michael Wonder on 04 Oct 2024
Blue Shield of California slashes cost of world's best selling drug
1 October 2024 - Non-profit health plan collaborates with Fresenius Kabi and Evio Pharmacy Solutions to purchase FDA approved Humira biosimilar ...
Posted by Michael Wonder on 17 Dec 2024
Johnson & Johnson submits application seeking US FDA approval of Simponi (golimumab) for the treatment of paediatric ulcerative colitis
16 December 2024 - Submission aims to expand Simponi ulcerative colitis indication to include paediatric population. ...
Posted by Michael Wonder on 17 Dec 2024
Arcutis submits Zorvye (roflumilast) cream 0.05% supplemental new drug application to the FDA for the treatment of children aged 2 to 5 with mild to moderate atopic dermatitis
16 December 2024 - Zorvye cream 0.05% provided meaningful disease clearance and rapid reduction in itch in pivotal trials. ...
Posted by Michael Wonder on 17 Dec 2024
Update on US regulatory review of subcutaneous amivantamab
16 December 2024 - Johnson & Johnson today announced the US FDA has issued a complete response letter for the ...
Posted by Michael Wonder on 17 Dec 2024
ICER publishes final evidence report on treatment for Epstein-Barr virus positive post-transplant lymphoproliferative disease
16 December 2024 - Independent appraisal committee voted that current evidence is adequate to demonstrate superior net health benefits for ...
Posted 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
FDA approves Vtama (tapinarof) cream, 1% for the treatment of atopic dermatitis in adults and children 2 years of age and older
16 December 2024 - In the pivotal studies, ADORING 1 and ADORING 2, up to 46% of patients on Vtama cream ...
Posted by Michael Wonder on 16 Dec 2024
Should NICE’s cost effectiveness thresholds change?
13 December 2024 - We explore the on-going debate around NICE’s cost effectiveness thresholds and what the future holds. ...
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 15 Dec 2024
ARS Pharmaceuticals announces filings for approval of neffy in China, Japan and Australia
12 December 2024 - Licensing partners in key Asia Pacific countries have filed for approval of neffy (epinephrine nasal spray) ...
Posted by Michael Wonder on 15 Dec 2024
Securing cheaper medicines for people with severe eczema
14 December 2024 - The Australian Government has ensured thousands of Australians living with severe eczema will continue to have ...
Posted by Michael Wonder on 14 Dec 2024
Galderma receives US FDA approval for Nemluvio (nemolizumab) for patients with moderate to severe atopic dermatitis
13 December 2024 - Galderma today announced that the US FDA has approved Nemluvio (nemolizumab) for the treatment of patients 12 ...
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. ...