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RSS FeedPosted by Michael Wonder on 22 Jul 2023
Janssen receives positive CHMP opinions for novel bispecific antibodies Talvey (talquetamab) and Tecvayli (teclistamab) for the treatment of patients with relapsed and refractory multiple myeloma
21 July 2023 - Talquetamab is the first therapy targeting GPRC5D to receive a positive CHMP opinion. ...
Posted by Michael Wonder on 22 Jul 2023
Highlights from the 17-20 July 2023 CHMP meeting
21 July 2023 - The EMA’s CHMP recommended 14 medicines for approval at its July 2023 meeting. ...
Posted by Michael Wonder on 22 Jul 2023
BeiGene announces positive CHMP opinion for tislelizumab as a treatment for advanced or metastatic oesophageal squamous cell carcinoma
21 July 2023 - BeiGene today announced that the CHMP of the EMA has issued a positive opinion recommending approval ...
Posted by Michael Wonder on 22 Jul 2023
Merck receives positive EU CHMP opinion for Keytruda (pembrolizumab) plus trastuzumab and chemotherapy as first-line treatment for HER2 positive advanced gastric or gastro-oesophageal junction adenocarcinoma expressing PD-L1 (CPS ≥1)
21 July 2023 - Opinion granted based on positive progression-free survival results from the Phase 3 KEYNOTE-811 trial. ...
Posted by Michael Wonder on 22 Jul 2023
Ipsen provides update on EU marketing authorisation application for Bylvay for cholestatic pruritus in patients with Alagille syndrome
21 July 2023 - Positive opinion from Committee for Medicinal Products for Human Use (CHMP) based on Bylvay Phase III ASSERT ...
Posted by Michael Wonder on 22 Jul 2023
CHMP recommends Roche’s Evrysdi for babies under two months old with spinal muscular atrophy
21 July 2023 - Positive recommendation is based on interim data from ongoing RAINBOWFISH trial which showed majority of Evrysdi treated ...
Posted by Michael Wonder on 22 Jul 2023
Menarini Group receives positive CHMP opinion recommending EC approval of Orserdu (elacestrant) for the treatment of patients with ER+, HER2- locally advanced or metastatic breast cancer with an activating ESR1 mutation
21 July 2023 - If approved by the European Commission, Orserdu would be the first and only treatment specifically indicated for ...
Posted by Michael Wonder on 22 Jul 2023
Merck receives positive European Union CHMP opinion for gefapixant
21 July 2023 - Merck today announced that the CHMP of the EMA has recommended the approval of gefapixant, an investigational, ...
Posted by Michael Wonder on 21 Jul 2023
AbbVie receives positive CHMP opinion for epcoritamab (Tepkinly) for the treatment of adults with relapsed/refractory diffuse large B-cell lymphoma
21 July 2023 - The positive CHMP opinion is supported by results from the EPCORE NHL-1 Phase 1/2 trial evaluating the ...
Posted by Michael Wonder on 20 Jul 2023
Ipsen announces European Commission decision on palovarotene for the treatment of FOP
19 July 2023 - European Commission determines not to grant marketing authorisation approval for palovarotene for fibrodysplasia ossificans progressiva. ...
Posted by Michael Wonder on 11 Jul 2023
European Commission approves Roche’s fixed-duration Columvi (glofitamab) for people with relapsed or refractory diffuse large B-cell lymphoma
11 July 2023 - Approval is based on results from the Phase I/II NP30179 study, where Columvi given as a fixed ...
Posted by Michael Wonder on 05 Jul 2023
European Commission approves Orkambi (lumacaftor/ivacaftor) for the treatment of children with cystic fibrosis ages 1 to 2 years old
5 July 2023 - Nearly 300 children with cystic fibrosis and two copies of the F508del mutation are now eligible ...
Posted by Michael Wonder on 05 Jul 2023
European Commission grants conditional marketing authorisation for Taiho's Lytgobi tablets for the treatment of adults with cholangiocarcinoma
4 July 2023 - Lytgobi is the first irreversibly binding FGFR inhibitor in the European Union for use in the ...
Posted by Michael Wonder on 30 Jun 2023
Bristol Myers Squibb receives European Commission 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%
29 June 2023 - Approval based on results from Phase 3 CheckMate-816 trial showing that neo-adjuvant Opdivo with chemotherapy improved ...
Posted by Michael Wonder on 29 Jun 2023
Amicus Therapeutics announces approval and launch of new Pompe disease therapy in the European Union
27 June 2023 - Pombiliti (cipaglucosidase alfa) and Opfolda (miglustat) now approved in the European Union for adults with late-onset Pompe ...