Blog
RSS FeedPosted by Michael Wonder on 27 Jul 2023
Soliris approved in the EU for children and adolescents with refractory generalised myasthenia gravis
27 July 2023 - First and only targeted therapy approved for paediatric patients with generalised myasthenia gravis in the EU ...
Posted by Michael Wonder on 26 Jul 2023
Jardiance (empagliflozin) approved in the EU for the treatment of adults with chronic kidney disease
25 July 2023 - Jardiance (empagliflozin) is the first SGLT-2 inhibitor to demonstrate a statistically significant reduction in all cause hospitalisations ...
Posted by Michael Wonder on 25 Jul 2023
Paving the way towards coordinated clinical trials in public health emergencies in the EU
25 July 2023 - EMA has published a report from a workshop that collected insights and suggestions for possible EU level ...
Posted by Michael Wonder on 24 Jul 2023
ViiV Healthcare’s cabotegravir for HIV prevention receives positive CHMP opinion from European Medicines Agency
24 July 2023 - Positive opinion is based on results from the HPTN 083 and 084 Phase IIb/III studies in which ...
Posted 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 24 Jul 2023
First RSV vaccine to protect infants up to 6 months of age and older adults
21 July 2023 - EMA has recommended granting a marketing authorisation in the European Union for Abrysvo, a vaccine to protect ...
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 ...