Blog
RSS FeedPosted 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. ...
Posted by Michael Wonder on 11 Jul 2023
EMA statement on on-going review of GLP-1 receptor agonists
11 July 2023 - EMA’s safety committee, the PRAC, is reviewing data on the risk of suicidal thoughts and thoughts ...
Posted by Michael Wonder on 11 Jul 2023
European Commission approves Roche’s fixed-duration Columvi (glofitamab) for people with relapsed or refractory diffuse large B-cell lymphoma
11 July 2023 - Approval is based on results from the Phase I/II NP30179 study, where Columvi given as a fixed ...
Posted by Michael Wonder on 07 Jul 2023
Phasing out of extraordinary COVID-19 regulatory flexibilities
6 July 2023 - EMA, the European Commission (EC) and the Heads of Medicines Agencies (HMA) are phasing out the ...
Posted by Michael Wonder on 06 Jul 2023
Therapeutic value of first versus supplemental indications of drugs in US and Europe (2011-20): retrospective cohort study
5 July 2023 - The objective was to analyse the therapeutic value of supplemental indications compared with first indications for ...
Posted by Michael Wonder on 05 Jul 2023
European Commission approves Orkambi (lumacaftor/ivacaftor) for the treatment of children with cystic fibrosis ages 1 to 2 years old
5 July 2023 - Nearly 300 children with cystic fibrosis and two copies of the F508del mutation are now eligible ...
Posted by Michael Wonder on 05 Jul 2023
European Commission grants conditional marketing authorisation for Taiho's Lytgobi tablets for the treatment of adults with cholangiocarcinoma
4 July 2023 - Lytgobi is the first irreversibly binding FGFR inhibitor in the European Union for use in the ...
Posted by Michael Wonder on 30 Jun 2023
Bristol Myers Squibb receives European Commission approval for Opdivo (nivolumab) with chemotherapy as neo-adjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in patients with tumour cell PD-L1 expression ≥1%
29 June 2023 - Approval based on results from Phase 3 CheckMate-816 trial showing that neo-adjuvant Opdivo with chemotherapy improved ...
Posted by Michael Wonder on 29 Jun 2023
Amicus Therapeutics announces approval and launch of new Pompe disease therapy in the European Union
27 June 2023 - Pombiliti (cipaglucosidase alfa) and Opfolda (miglustat) now approved in the European Union for adults with late-onset Pompe ...