Blog
RSS FeedPosted by Michael Wonder on 22 Jul 2023
Ipsen provides update on EU marketing authorisation application for Bylvay for cholestatic pruritus in patients with Alagille syndrome
21 July 2023 - Positive opinion from Committee for Medicinal Products for Human Use (CHMP) based on Bylvay Phase III ASSERT ...
Posted by Michael Wonder on 22 Jul 2023
CHMP recommends Roche’s Evrysdi for babies under two months old with spinal muscular atrophy
21 July 2023 - Positive recommendation is based on interim data from ongoing RAINBOWFISH trial which showed majority of Evrysdi treated ...
Posted by Michael Wonder on 22 Jul 2023
Menarini Group receives positive CHMP opinion recommending EC approval of Orserdu (elacestrant) for the treatment of patients with ER+, HER2- locally advanced or metastatic breast cancer with an activating ESR1 mutation
21 July 2023 - If approved by the European Commission, Orserdu would be the first and only treatment specifically indicated for ...
Posted by Michael Wonder on 22 Jul 2023
Merck receives positive European Union CHMP opinion for gefapixant
21 July 2023 - Merck today announced that the CHMP of the EMA has recommended the approval of gefapixant, an investigational, ...
Posted by Michael Wonder on 21 Jul 2023
AbbVie receives positive CHMP opinion for epcoritamab (Tepkinly) for the treatment of adults with relapsed/refractory diffuse large B-cell lymphoma
21 July 2023 - The positive CHMP opinion is supported by results from the EPCORE NHL-1 Phase 1/2 trial evaluating the ...
Posted by Michael Wonder on 20 Jul 2023
OPEN framework extended to a wider range of medicines
20 July 2023 - EMA has expanded the scope of the OPEN initiative from COVID-19 vaccines and treatments to a ...
Posted by Michael Wonder on 20 Jul 2023
Ipsen announces European Commission decision on palovarotene for the treatment of FOP
19 July 2023 - European Commission determines not to grant marketing authorisation approval for palovarotene for fibrodysplasia ossificans progressiva. ...
Posted by Michael Wonder on 19 Jul 2023
Reflection paper on the use of artificial intelligence in the lifecycle of medicines
19 July 2023 - The EMA has published a draft reflection paper outlining the current thinking on the use of artificial ...
Posted by Michael Wonder on 18 Jul 2023
Roche withdraws type II variation for Gazyvaro
18 July 2023 - The EMA has published the letter from Roche on its website. ...
Posted by Michael Wonder on 18 Jul 2023
UCB announces EU regulatory filing for bimekizumab for the treatment of moderate to severe hidradenitis suppurativa
18 July 2023 - Regulatory filing supported by data from two bimekizumab Phase 3 studies in hidradenitis suppurativa. ...
Posted by Michael Wonder on 17 Jul 2023
European Health Union: EU steps up action to prevent shortages of antibiotics for next winter
17 July 2023 - The European Commission, the Heads of Medicines Agencies and the European Medicines Agency are today issuing recommendations ...
Posted by Michael Wonder on 17 Jul 2023
EMA publishes agenda for 17-20 July CHMP meeting
17 July 2023 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 15 Jul 2023
European Medicine Agency accepts Intas' marketing authorisation application for DMB-3115, a proposed biosimilar to Stelara (ustekinumab)
14 July 2023 - Therapeutic equivalence and safety confirmed between DMB-3115 and Stelara in global Phase 3 trial. ...
Posted by Michael Wonder on 14 Jul 2023
European Medicines Agency accepts Astellas' marketing authorisation application for zolbetuximab
13 July 2023 - Astellas Pharma today announced the EMA has accepted for regulatory review the company's marketing authorisation application for ...
Posted by Michael Wonder on 13 Jul 2023
Dr. Reddy’s proposed rituximab biosimilar application accepted for review by US FDA, EMA and MHRA
12 July 2023 - Following dossier submission in April 2023, the regulatory agencies have now accepted the dossier for review. ...