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RSS FeedPosted by Michael Wonder on 13 Dec 2024
Lilly's Omvoh (mirikizumab) recommended by CHMP for approval in the European Union for adults with moderately to severely active Crohn's disease
13 December 2024 - The Phase 3 VIVID-1 trial evaluated the safety and efficacy of Omvoh in patients with or without ...
Posted by Michael Wonder on 13 Dec 2024
Vir Biotechnology receives FDA breakthrough therapy designation and EMA PRIME designation for tobevibart and elebsiran in chronic hepatitis delta
12 December 2024 - Phase 3 ECLIPSE registrational program in chronic hepatitis delta to begin in the first half of 2025. ...
Posted by Michael Wonder on 11 Dec 2024
Krystal Biotech provides update on EMA’s on-going regulatory review of B-VEC for dystrophic epidermolysis bullosa
9 December 2024 - CHMP opinion now expected in Q1, 2025. ...
Posted by Michael Wonder on 10 Dec 2024
EMA publishes agenda for 9-12 December 2024 CHMP meeting
9 December 2024 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 10 Dec 2024
Chiesi Global Rare Diseases and Protalix BioTherapeutics announce validation of variation submission by EMA for pegunigalsidase alfa
9 December 2024 - Application to label a less frequent dosing regimen at a dose of 2 mg/kg body weight ...
Posted by Michael Wonder on 06 Dec 2024
Positive CHMP opinion for the extension of indication of Palforzia for the treatment of toddlers with confirmed peanut allergy
2 December 2024 - Stallergenes Greer today announced that the CHMP of the EMA provided a positive opinion for the extension ...
Posted by Michael Wonder on 05 Dec 2024
Orphelia Pharma provides update on the regulatory submission of Kizfizo with the EMA
18 November 2024 - Orphelia to seek re-examination following CHMP negative opinion for the treatment of relapsed or refractory high-risk ...
Posted by Michael Wonder on 05 Dec 2024
GSK’s fully liquid Menveo meningococcal vaccine approved by European Commission
27 November 2024 - New fully liquid presentation means reconstitution is not needed before use. ...
Posted by Michael Wonder on 05 Dec 2024
European Commission approves BeiGene’s Tevimbra for first-line treatment of advanced/metastatic oesophageal squamous cell carcinoma and gastric or gastro-oesophageal junction cancer
27 November 2024 - New indications based on two Phase 3 studies demonstrating statistically significant overall survival benefit for patients ...
Posted by Michael Wonder on 04 Dec 2024
Anavex Life Sciences announces submission of blarcamesine MAA for treatment of Alzheimer’s disease to EMA
26 November 2024 - First marketing authorisation submission for blarcamesine. ...
Posted by Michael Wonder on 04 Dec 2024
Novartis Kisqali receives European Commission approval in a broad population of patients with HR positive/HER2 negative early breast cancer at high risk of recurrence
27 November 2024 - Approval is based on Phase 3 NATALEE data showing Kisqali (ribociclib) plus adjuvant endocrine therapy demonstrated clinically ...
Posted by Michael Wonder on 30 Nov 2024
Nurix Therapeutics receives PRIME designation from the EMA for NX-5948 for the treatment of relapsed or refractory chronic lymphocytic leukaemia
20 November 2024 - Pivotal trials of NX-5948 are planned to initiate in 2025. ...
Posted by Michael Wonder on 28 Nov 2024
European Commission approves Pfizer’s Hympavzi (marstacimab) for the treatment of adults and adolescents with severe haemophilia A or B without inhibitors
20 November 2024 - In the EU, Hympavzi is the first once weekly subcutaneous treatment approved for eligible people living with ...
Posted by Michael Wonder on 18 Nov 2024
Merck receives positive EU CHMP opinion for Keytruda (pembrolizumab) plus chemotherapy as first-line treatment for adult patients with unresectable non-epithelioid malignant pleural mesothelioma
15 November 2024 - Opinion granted based on positive overall survival results from the IND.227/KEYNOTE-483 trial. ...
Posted by Michael Wonder on 18 Nov 2024
Tagrisso recommended for approval in the EU by CHMP for patients with unresectable EGFR mutated lung cancer
18 November 2024 - Recommendation based on LAURA Phase 3 trial results which showed Tagrisso extended median progression-free survival to ...