Blog
RSS FeedPosted by Michael Wonder on 29 May 2023
EMA recommends revocation of authorisation for sickle cell disease medicine Adakveo
26 May 2023 - The EMA’s CHMP has recommended revoking the marketing authorisation for Adakveo (crizanlizumab), a medicine for preventing ...
Posted by Michael Wonder on 29 May 2023
Marinus Pharmaceuticals receives positive CHMP opinion for Ztalmy (ganaxolone) for the adjunctive treatment of seizures associated with CDKL5 deficiency disorder
26 May 2023 - The European Commission decision is expected within 67 days of the CHMP opinion. ...
Posted by Michael Wonder on 28 May 2023
Bristol Myers Squibb receives positive CHMP opinion recommending approval for Opdivo (nivolumab) with chemotherapy as neo-adjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in patients with tumour cell PD-L1 expression ≥1%
26 May 2023 - Recommendation based on results from the Phase 3 CheckMate-816 trial, in which Opdivo with chemotherapy demonstrated improved ...
Posted 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 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 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 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 ...
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 ...
Posted by Michael Wonder on 27 Apr 2023
Bristol Myers Squibb receives positive CHMP opinion recommending approval for Camzyos (mavacamten) for the treatment of symptomatic obstructive hypertrophic cardiomyopathy
26 April 2023 - Recommendation based on positive Phase 3 EXPLORER-HCM and VALOR-HCM trials demonstrating benefit in patients receiving Camzyos ...
Posted by Michael Wonder on 27 Apr 2023
First vaccine to protect older adults from respiratory syncytial virus (RSV) infection
26 April 2023 - EMA has recommended a marketing authorisation in the European Union for Arexvy (recombinant, adjuvanted), the first vaccine ...
Posted by Michael Wonder on 26 Apr 2023
Highlights from the 24-26 April 2023 CHMP meeting
26 April 2023 - The EMA’s CHMP recommended seven medicines for approval at its April 2023 meeting. ...