Blog
RSS FeedPosted by Michael Wonder on 25 May 2023
Sandoz marketing authorisation applications for proposed biosimilar denosumab accepted by EMA
25 May 2023 - Submissions supported by comprehensive analytical and clinical data package including a Phase I PK/PD similarity study and ...
Posted by Michael Wonder on 23 May 2023
Pierre Fabre announces start of EU marketing authorization application procedure for vibegron in overactive bladder
22 May 2023 - Following the exclusive licensing agreement with Urovant Sciences, Pierre Fabre announced today the start of the ...
Posted by Michael Wonder on 22 May 2023
EMA publishes agenda for 22-25 May 2023 CHMP meeting
22 May 2023 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 20 May 2023
EMA validates marketing authorisation application for efanesoctocog alfa for treatment of haemophilia A
19 May 2023 - Sobi today announced that the EMA has accepted and validated a marketing authorisation application for efanesoctocog alfa, ...
Posted by Michael Wonder on 18 May 2023
Guidance for industry to prevent and mitigate medicine shortages
17 May 2023 - EMA has published recommendations for industry on good practices to ensure continuity in the supply of ...
Posted by Michael Wonder on 17 May 2023
Publication of EMA Annual Report 2022
15 May 2023 - EMA published its annual report 2022 today. ...
Posted by Michael Wonder on 11 May 2023
EMA and European medicines regulatory network lift COVID-19 business continuity status
10 May 2023 - EMA and the European medicines regulatory network are lifting their respective COVID-19 business continuity measures after successfully ...
Posted by Michael Wonder on 11 May 2023
Servier receives European Commission approval of Tibsovo (ivosidenib tablets) in IDH1 mutated acute myeloid leukaemia and IDH1 mutated cholangiocarcinoma
10 May 2023 - Marketing Authorization granted for Tibsovo as the first and only approved IDH1 targeted therapy in Europe. ...
Posted by Michael Wonder on 10 May 2023
Ultomiris approved in the EU for adults with neuromyelitis optica spectrum disorder
10 May 2023 - Ultomiris transforms the treatment landscape for anti-aquaporin-4 antibody-positive neuromyelitis optica spectrum disorder patients, with potential to eliminate ...
Posted by Michael Wonder on 10 May 2023
Reforming EU and national orphan drug regulations to improve outcomes for patients with rare diseases
9 May 2023 - In Europe, the number of approvals for new drugs targeting rare diseases (orphan drugs) has risen ...
Posted by Michael Wonder on 09 May 2023
Chiesi Global Rare Diseases and Protalix BioTherapeutics announce European Commission authorisation of PRX-102 (pegunigalsidase alfa) for the treatment of Fabry disease
5 May 2023 - PEGylated enzyme replacement therapy designed to provide a long half-life. ...
Posted by Michael Wonder on 09 May 2023
Statement from Emer Cooke on the end of the COVID-19 public health emergency
9 May 2023 - On Friday, the WHO Director General declared an end to the Public Health Emergency of International Concern ...
Posted by Michael Wonder on 05 May 2023
CHMP adopts positive opinion recommending Hepcludex (bulevirtide) for full marketing authorization for the treatment of hepatitis delta virus
4 May 2023 - If granted by the European Commission, Hepcludex will become the only approved treatment for HDV in the ...
Posted by Michael Wonder on 04 May 2023
Gene therapies are still hampered by substantial delays between approval and launch
3 May 2023 - Gene therapies hold promise for treating a wide range of diseases. Innovative companies such as bluebird bio ...
Posted by Michael Wonder on 04 May 2023
Bristol Myers Squibb receives European Commission approval for CAR T cell therapy Breyanzi (lisocabtagene maraleucel) for relapsed or refractory large B-cell lymphoma after one prior therapy
3 May 2023 - Approval of Breyanzi based on the pivotal Phase 3 TRANSFORM trial, in which Breyanzi significantly improved ...