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RSS FeedPosted by Michael Wonder on 27 May 2023
Highlights from the CHMP 22-25 May 2023 meeting
26 May 2023 - The EMA’s CHMP recommended two medicines for approval at its May 2023 meeting. ...
Posted 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 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 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 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 01 May 2023
US FDA accepts for priority review supplemental biologics license application and EMA validates application for Reblozyl (luspatercept-aamt) as first-line treatment of anaemia in adults with lower-risk myelodysplastic syndromes
1 May 2023 - Applications based on results from Phase 3 COMMANDS study in which first-in-class Reblozyl demonstrated a highly statistically ...
Posted by Michael Wonder on 28 Apr 2023
CHMP issues positive opinion for futibatinib for the treatment of adults with cholangiocarcinoma
27 April 2023 - Taiho Pharmaceutical announced today that the EMA's CHMP has issued a positive opinion recommending the conditional ...
Posted by Michael Wonder on 27 Apr 2023
UCB receives positive CHMP opinions for bimekizumab for the treatment of adults with psoriatic arthritis and axial spondyloarthritis in the European Union
27 April 2023 - Positive CHMP opinions are supported by data from four Phase 3 studies that evaluated bimekizumab in active ...
Posted by Michael Wonder on 27 Apr 2023
Novartis Cosentyx gains positive CHMP opinion for hidradenitis suppurativa
26 April 2023 - Positive opinion paves way for first new treatment option in hidradenitis suppurativa in nearly a decade. ...
Posted by Michael Wonder on 27 Apr 2023
CHMP recommends EU approval of Roche’s fixed-duration Columvi (glofitamab) for people with relapsed or refractory diffuse large B-cell lymphoma
26 April 2023 - The recommendation is based on results from the Phase I/II NP30179 study, where Columvi given as a ...