Blog
RSS FeedPosted by Michael Wonder on 22 Feb 2022
BeiGene announces European Medicines Agency acceptance of applications for Brukinsa (zanubrutinib) in chronic lymphocytic leukaemia and marginal zone lymphoma
22 February 2022 - The CLL filing is supported by two global Phase 3 trials of Brukinsa in chronic lymphocytic leukaemia ...
Posted by Michael Wonder on 17 Feb 2022
Nirsevimab EMA regulatory submission accepted under accelerated assessment for RSV protection in all infants
17 February 2022 - Nirsevimab is the first investigational long-acting antibody designed to protect all infants for the respiratory syncytial ...
Posted by Michael Wonder on 08 Feb 2022
EMA evaluating data on booster dose of COVID-19 vaccine Comirnaty in adolescents
8 February 2022 - EMA has started evaluating an application for the use of a booster dose of Comirnaty (BioNTech/Pfizer’s vaccine) ...
Posted by Michael Wonder on 01 Feb 2022
Janssen submits marketing authorisation application to the EMA seeking approval of bispecific antibody teclistamab for the treatment of patients with relapsed or refractory multiple myeloma
31 January 2022 - The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a marketing authorisation application ...
Posted by Michael Wonder on 19 Jan 2022
FDA accepts for review Libtayo (cemiplimab-rwlc) in combination with chemotherapy for first-line treatment of advanced NSCLC
19 January 2022 - Regulatory filing recently submitted in the European Union. ...
Posted by Michael Wonder on 10 Jan 2022
EMA receives application for conditional marketing authorisation for Paxlovid (PF-07321332 and ritonavir) for treating patients with COVID-19
10 January 2022 - EMA has started evaluating an application for a conditional marketing authorisation for the oral antiviral medicine ...
Posted by Michael Wonder on 07 Jan 2022
AbbVie submits applications for upadacitinib (Rinvoq) in non-radiographic axial spondyloarthritis to U.S. FDA and EMA
7 January 2022 - Submissions supported by Phase 3 study in which upadacitinib (Rinvoq) demonstrated significant improvements in signs and symptoms ...
Posted by Michael Wonder on 05 Jan 2022
Amylyx Pharmaceuticals submits marketing authorisation application for AMX0035 for the Treatment of ALS
4 January 2022 - Amylyx Pharmaceuticals today announced it has submitted a marketing authorisation application to the EMA's CHMP for ...
Posted by Michael Wonder on 04 Jan 2022
Zogenix submits type II variation application to the EMA to expand the use of Fintepla (fenfluramine) for the treatment of seizures associated with Lennox-Gastaut syndrome
20 December 2021 - Zogenix today announced that it has submitted its type II variation market authorisation application to the EMA ...
Posted by Michael Wonder on 01 Jan 2022
Paion submits extension application of marketing authorisation for remimazolam in the indication general anaesthesia to the European Medicines Agency
31 December 2021 - Paion today announces that it has submitted an extension application to the marketing authorisation for remimazolam ...
Posted by Michael Wonder on 28 Dec 2021
Trastuzumab deruxtecan type II variation application validated by EMA for patients with HER2 positive metastatic breast cancer treated with a prior anti-HER2 based regimen
28 December 2021 - Application based on DESTINY-Breast03 results showing Daiichi Sankyo and AstraZeneca’s trastuzumab deruxtecan reduced risk of disease progression ...
Posted by Michael Wonder on 22 Dec 2021
Helsinn Group announces EMA acceptance for review of the marketing authorisation application for infigratinib for patients with cholangiocarcinoma with fibroblast growth factor receptor 2 fusions or rearrangements
21 December 2021 - Helsinn today announced that the EMA accepted for review the Company’s marketing authorisation application for infigratinib for ...
Posted by Michael Wonder on 16 Dec 2021
CSL Behring receives accelerated CHMP assessment for etranacogene dezaparvovec for European patients living with haemophilia B
15 December 2021 - CSL Behring today announced that the CHMP, the chief scientific body of the EMA accepted its ...
Posted by Michael Wonder on 15 Dec 2021
Alnylam submits regulatory applications to the U.S. FDA and EMA to support label expansion for Oxlumo for the treatment of advanced primary hyperoxaluria type 1
14 December 2021 - Findings from the ILLUMINATE-C Phase 3 study showed substantial reductions in plasma oxalate in PH1 patients with ...
Posted by Michael Wonder on 14 Dec 2021
EMA reviewing new data on effectiveness of Lagevrio (molnupiravir) for the treatment of COVID-19
14 December 2021 - Following EMA’s interim recommendations to support national authorities who may decide on early use of Lagevrio ...