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RSS FeedPosted by Michael Wonder on 27 Jul 2024
Leo Pharma receives positive CHMP opinion of Anzupgo (delgocitinib cream) for the treatment of adults with moderate to severe chronic hand eczema
26 July 2024 - The positive opinion is based on results from the DELTA phase 3 program, which includes the randomised, ...
Posted by Michael Wonder on 27 Jul 2024
Ipsen receives CHMP positive opinions for Iqirvo (elafibranor) in primary biliary cholangitis and Kayfanda (odevixibat) in Alagille syndrome, two rare cholestatic liver diseases
26 July 2024 - Ipsen announced today two positive opinions by the EMA's CHMP for two different rare cholestatic liver disease ...
Posted by Michael Wonder on 27 Jul 2024
Vertex announces FDA acceptance of new drug application for vanzacaftor/tezacaftor/deutivacaftor, a next in class triple combination treatment for cystic fibrosis
2 July 2024 - Vanza triple granted priority review with a PDUFA target action date of 2 January 2025. ...
Posted by Michael Wonder on 27 Jul 2024
Astellas receives positive CHMP opinion for zolbetuximab in combination with chemotherapy for treatment of advanced gastric and gastro-oesophageal junction cancer
26 July 2024 - If approved by the European Commission, zolbetuximab would become the first and only CLDN18.2 targeted therapy approved ...
Posted by Michael Wonder on 27 Jul 2024
Astellas receives positive CHMP opinion for Padcev (enfortumab vedotin) in combination with Keytruda (pembrolizumab) for first-line treatment of advanced bladder cancer
26 July 2024 - Positive opinion is based on Phase 3 EV-302 clinical trial results which showed enfortumab vedotin in combination ...
Posted by Michael Wonder on 26 Jul 2024
AbbVie announces European Commission approval of Skyrizi (risankizumab) for the treatment of adults with moderately to severely active ulcerative colitis
26 July 2024 - The approval is supported by data from two pivotal Phase 3 trials: the INSPIRE induction trial and ...
Posted by Michael Wonder on 26 Jul 2024
Sandoz launches biosimilar Pyzchiva (ustekinumab) across Europe, to treat chronic inflammatory diseases
25 July 2024 - Pyzchiva first ustekinumab biosimilar to launch in Europe with all reference medicine strengths, including 130 mg vial ...
Posted by Michael Wonder on 26 Jul 2024
EMA publishes agenda for 22-25 July 2024 CHMP meeting
22 July 2024 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 26 Jul 2024
European Commission approves Pfizer’s Durveqtix (fidanacogene elaparvovec), a one-time gene therapy for adults with haemophilia B
25 July 2024 - A one-time dose of Durveqtix has reduced bleeds post-treatment compared to standard of care with a median ...
Posted by Michael Wonder on 25 Jul 2024
Bio-Thera Solutions announces regulatory filing acceptance for BAT2206, a proposed biosimilar to Stelara in the US and EU
24 July 2024 - The BAT2206 BLA and MAA are based on a robust analytical, non-clinical and clinical data package ...
Posted by Michael Wonder on 20 Jul 2024
EMA accepts Deciphera’s marketing authorisation application for vimseltinib for treatment of patients with tenosynovial giant cell tumour
18 July 2024 - Application based on results from the MOTION Phase 3 study, in which vimseltinib demonstrated statistically significant and ...
Posted by Michael Wonder on 20 Jul 2024
Blenrep (belantamab mafodotin) combinations in multiple myeloma application accepted for review by the EMA
19 July 2024 - Regulatory submission supported by Phase 3 head to head DREAMM-7 and DREAMM-8 trials. ...
Posted by Michael Wonder on 19 Jul 2024
Bristol Myers Squibb receives EMA validation of application for Opdivo (nivolumab) plus Yervoy (ipilimumab) for first-line treatment of unresectable or advanced hepatocellular carcinoma
19 July 2024 - The Application is based on Phase 3 CheckMate-9DW trial results demonstrating improved survival with Opdivo plus ...
Posted by Michael Wonder on 19 Jul 2024
Bavarian Nordic receives EMA filing acceptance and validation of the MAA for its chikungunya vaccine
18 July 2024 - EMA will now initiate its centralised review procedure under accelerated assessment for Bavarian Nordic’s chikungunya vaccine. ...
Posted by Michael Wonder on 14 Jul 2024
Fresenius announces EMA validation of marketing authorisation application for denosumab biosimilar candidates
11 July 2024 - Fresenius, via its operating company Fresenius Kabi, announced that the EMA has accepted for review the company’s ...