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RSS FeedPosted by Michael Wonder on 24 Jul 2023
Jazz Pharmaceuticals receives CHMP positive opinion for JZP458 (a recombinant Erwinia asparaginase or crisantaspase) for the treatment of acute lymphoblastic leukaemia and lymphoblastic lymphoma
21 July 2023 - Jazz Pharmaceuticals today announced that the EMA's CHMP adopted a positive opinion recommending the marketing authorisation of ...
Posted by Michael Wonder on 24 Jul 2023
Biocon Biologics announces positive CHMP opinion for Yesafili, biosimilar aflibercept
24 July 2023 - Biocon Biologics today announced that the EMA’s CHMP has issued a positive opinion recommending approval of ...
Posted by Michael Wonder on 24 Jul 2023
Sandoz receives positive CHMP opinion for multiple sclerosis biosimilar natalizumab
24 July 2023 - Positive CHMP opinion based on evidence from extensive analytical characterisation confirming similarity of biosimilar with reference biologic, ...
Posted 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
OPEN framework extended to a wider range of medicines
20 July 2023 - EMA has expanded the scope of the OPEN initiative from COVID-19 vaccines and treatments to a ...
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 19 Jul 2023
Reflection paper on the use of artificial intelligence in the lifecycle of medicines
19 July 2023 - The EMA has published a draft reflection paper outlining the current thinking on the use of artificial ...