Blog
RSS FeedPosted by Michael Wonder on 03 Dec 2022
European Medicines Agency accepts marketing authorisation application for momelotinib for the treatment of myelofibrosis
2 December 2022 - Application includes data from key Phase 3 trials, including the pivotal MOMENTUM trial, which met all ...
Posted by Michael Wonder on 03 Dec 2022
EQRx announces acceptance of marketing authorisation application by the European Medicines Agency for aumolertinib in EGFR mutated non-small-cell lung cancer
2 December 2022 - Application is based on data from the pivotal Phase 3 AENEAS trial evaluating aumolertinib as first-line ...
Posted by Michael Wonder on 30 Nov 2022
European Commission grants expanded marketing authorisation for Gilead’s Biktarvy for the treatment of HIV in paediatric populations
29 November 2022 - European Commission authorises a low dose tablet for HIV treatment in virologically suppressed children at least two ...
Posted by Michael Wonder on 29 Nov 2022
Capstone announces authorisation of biosimilar human insulin for IV infusion in Canada and EU
29 November 2022 - Capstone announced today that a biosimilar version of human insulin received authorisation from the EMA's CHMP ...
Posted by Michael Wonder on 23 Nov 2022
DARWIN EU welcomes first data partners
23 November 2022 - EMA has selected the first set of data partners to collaborate with DARWIN EU, the Data Analysis ...
Posted by Michael Wonder on 23 Nov 2022
AbbVie announces European Commission approval of Skyrizi (risankizumab) for the treatment of moderate to severe active Crohn's disease
23 November 2022 - Third approved indication for Skyrizi (risankizumab) and the first specific IL-23 inhibitor for the treatment of Crohn's ...
Posted by Michael Wonder on 22 Nov 2022
Libtayo (cemiplimab) approved by the European Commission as the first immunotherapy in second-line recurrent or metastatic cervical cancer irrespective of PD-L1 expression level or tumour histology
22 November 2022 - Approval based on a Phase 3 trial that demonstrated significant survival benefit in patients with recurrent or ...
Posted by Michael Wonder on 21 Nov 2022
New Quality Innovation Expert Group supports medicine innovation
21 November 2022 - The EMA has established a Quality Innovation Expert Group to support innovative approaches for the development, ...
Posted by Michael Wonder on 19 Nov 2022
BeiGene receives European Commission approval for Brukinsa (zanubrutinib) for the treatment of adults with chronic lymphocytic leukaemia
17 November 2022 - Brukinsa is the only Bruton’s tyrosine kinase inhibitor to achieve superiority over ibrutinib in relapsed/refractory chronic lymphocytic ...
Posted by Michael Wonder on 19 Nov 2022
European Commission approves Enjaymo (sutimlimab) for treatment of haemolytic anaemia in adult patients with cold agglutinin disease
17 November 2022 - Enjaymo is the first and only approved therapeutic option approved for haemolytic anaemia in adult patients ...
Posted by Michael Wonder on 15 Nov 2022
Lynparza in combination with abiraterone recommended for approval in the EU by CHMP as first-line treatment for patients with metastatic castration-resistant prostate cancer
14 November 2022 - First PARP inhibitor to demonstrate clinical benefit in combination with a new hormonal agent in this ...
Posted by Michael Wonder on 15 Nov 2022
Junshi Biosciences announces submission of a marketing authorisation application to the European Medicines Agency for toripalimab
14 November 2022 - The MAA was submitted in the EU for toripalimab seeking indications for the first-line treatment of NPC ...
Posted by Michael Wonder on 15 Nov 2022
Enhertu recommended for approval in the EU by CHMP for patients with previously treated HER2 positive advanced gastric cancer
14 November 2022 - Based on DESTINY-Gastric02, which showed Daiichi Sankyo and AstraZeneca’s Enhertu demonstrated clinically meaningful efficacy and DESTINY-Gastric01, which ...
Posted by Michael Wonder on 15 Nov 2022
Imfinzi plus chemotherapy recommended for approval in the EU by CHMP as first immunotherapy regimen for advanced biliary tract cancer
14 November 2022 - Positive opinion based on TOPAZ-1 Phase 3 trial updated survival results showing Imfinzi combination reduced risk ...
Posted by Michael Wonder on 14 Nov 2022
UCB announces US FDA acceptance of new drug application and EMA MAA validation for zilucoplan for the treatment of generalized myasthenia gravis in adult patients
14 November 2022 - New drug application for zilucoplan seeks approval for the treatment of generalised myasthenia gravis in adult patients ...