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RSS FeedPosted 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
Moderna announces global regulatory submissions for its respiratory syncytial virus (RSV) vaccine, mRNA-1345
5 July 2023 - Moderna has submitted marketing authorization applications for the investigational RSV vaccine, mRNA-1345, with the European Medicines Agency, ...
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
Global regulators confirm good safety profile of COVID-19 vaccines
5 July 2023 - EMA has just endorsed a joint statement on the safety of COVID-19 vaccines issued by the ...
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 04 Jul 2023
Moderna submits regulatory application to the EMA for its updated COVID-19 vaccine
3 July 2023 - The filing follows the recommendation from regulators and global public health bodies to develop monovalent XBB.1.5 COVID-19 ...
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 ...
Posted by Michael Wonder on 29 Jun 2023
Esperion announces submission of application for expanded indication with the EMA for Nilemdo (bempedoic acid) tablet and Nustendi (bempedoic acid and ezetimibe) tablet
28 June 2023 - Seeking inclusion of CV risk reduction indications in Europe. ...
Posted by Michael Wonder on 28 Jun 2023
Merck, Ridgeback withdraw COVID drug application in EU
27 June 2023 - Merck and partner Ridgeback Biotherapeutics said on Tuesday they had withdrawn their COVID-19 pill application in ...
Posted by Michael Wonder on 28 Jun 2023
Bristol Myers Squibb receives European Commission approval of Camzyos (mavacamten) for the treatment of symptomatic obstructive hypertrophic cardiomyopathy
26 June 2023 - Approval based on two positive Phase 3 trials, EXPLORER-HCM and VALOR-HCM, demonstrating significant benefit in patients ...
Posted by Michael Wonder on 27 Jun 2023
Janssen submits marketing authorisation application to the EMA seeking approval of single tablet combination therapy of macitentan and tadalafil for treatment of patients with pulmonary arterial hypertension
26 June 2023 - This is the first and only single tablet combination therapy to be submitted for review in Europe ...