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RSS FeedPosted by Michael Wonder on 23 Jan 2023
EMA publishes agenda for 23-26 January 2023 CHMP meeting
23 January 2023 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 23 Jan 2023
The EMA validated regulatory application for arpraziquantel, a potential treatment for schistosomiasis in pre-school aged children
23 January 2023 - Arpraziquantel is the first investigational drug in regulatory phase amongst the different projects supported by the Global ...
Posted by Michael Wonder on 19 Jan 2023
The battle over European drug pricing
19 January 2023 - UK and EU must balance health cost control with plans to grow life sciences. ...
Posted by Michael Wonder on 18 Jan 2023
Forge Biologics receives PRIME designation from the EMA for novel gene therapy FBX-101 for the treatment of patients with Krabbe disease
17 January 2023 - FBX-101 is granted priority medicines (PRIME) designation by the EMA after review of Phase 1/2 RESKUE clinical ...
Posted by Michael Wonder on 14 Jan 2023
Roche announces the European Commission approval of Xofluza for the treatment and prevention of influenza in children aged one year and above
12 January 2023 - Xofluza is now approved in the EU for the treatment of uncomplicated influenza and for post-exposure prophylaxis ...
Posted by Michael Wonder on 13 Jan 2023
Tezspire approved for self-administration in the EU in a new pre-filled pen
13 January 2023 - New administration option for first and only severe asthma biologic approved in the EU with no ...
Posted by Michael Wonder on 12 Jan 2023
Eisai submits marketing authorisation application for lecanemab as treatment for early Alzheimer's disease in Europe
11 January 2023 - Eisai and Biogen announced today that Eisai has submitted a marketing authorisation application for lecanemab, an investigational ...
Posted by Michael Wonder on 06 Jan 2023
UCB announces rozanolixizumab BLA for the treatment of generalised myasthenia gravis filed with US FDA and designated for priority review
6 January 2023 - Biologic license application designated priority review by FDA and seeks approval for rozanolixizumab for the treatment ...
Posted by Michael Wonder on 04 Jan 2023
Enhertu type II variation application validated by EMA for the treatment of HER2 mutant metastatic non-small-cell lung cancer
4 January 2022 - Submission based on DESTINY-Lung02 and DESTINY-Lung01 Phase 2 trial results which showed Daiichi Sankyo and AstraZeneca’s Enhertu ...
Posted by Michael Wonder on 04 Jan 2023
Janssen submits marketing authorisation application to the European Medicines Agency seeking approval of talquetamab for the treatment of patients with relapsed or refractory multiple myeloma
3 January 2023 - Janssen today announced the submission of a marketing authorisation application to the EMA seeking approval of ...
Posted by Michael Wonder on 04 Jan 2023
European Medicines Agency validates marketing authorisation application for Trodelvy (sacituzumab govitecan-hziy) for pre-treated HR+/HER2- metastatic breast cancer
3 January 2023 - Application based on statistically significant and clinically meaningful overall survival and progression-free survival results from the Phase ...
Posted by Michael Wonder on 04 Jan 2023
European Medicines Agency validates application for extension of indication for Vozogo (vosoritide) for injection to treat children with achondroplasia under the age of 2
4 January 2023 - BioMarin submits supplemental new drug application to US FDA to expand label to treat children with achondroplasia ...
Posted by Michael Wonder on 23 Dec 2022
Outlook Therapeutics announces validation of marketing authorisation application by the European Medicines Agency for ONS-5010 as a treatment for wet AMD
22 December 2022 - Submission follows the US FDA acceptance of the ONS-5010 BLA for wet AMD, with a PDUFA ...
Posted by Michael Wonder on 22 Dec 2022
Zynlonta (loncastuximab tesirine) approved in the EU for the treatment of relapsed or refractory diffuse large B-cell lymphoma
21 December 2022 - Sobi and ADC Therapeutics today announced that the European Commission has granted conditional marketing authorisation for the ...
Posted by Michael Wonder on 21 Dec 2022
Pfizer announces FDA and EMA acceptance of etrasimod regulatory submissions for ulcerative colitis
21 December 2022 - Filings based on two Phase 3 trials demonstrating significant clinical remission versus placebo and safety profile ...