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RSS FeedPosted by Michael Wonder on 05 Nov 2024
European Medicines Agency confirms acceptance of marketing authorisation application for AVT05, a proposed biosimilar to Simponi (golimumab)
4 November 2024 - Alvotech and Advanz Pharma today announced that the EMA has accepted a marketing authorisation application for AVT05, ...
Posted by Michael Wonder on 28 Oct 2024
Astellas provides update on marketing authorisation application for avacincaptad pegol in the European Union
28 October 2024 - Astellas today announced the company's decision to withdraw its marketing authorisation application from the EMA for ...
Posted by Michael Wonder on 28 Oct 2024
Fasenra approved in the EU for eosinophilic granulomatosis with polyangiitis
28 October 2024 - New indication supported by the MANDARA trial, which showed nearly 60% of patients achieved remission and ...
Posted by Michael Wonder on 24 Oct 2024
Merck’s Keytruda (pembrolizumab) receives 30th approval from European Commission with two new indications in gynaecologic cancers
24 October 2024 - Keytruda plus chemotherapy is the first approval in the EU for an anti-PD-1 therapy combined with chemotherapy ...
Posted by Michael Wonder on 22 Oct 2024
CHMP recommends the approval of Dong-A ST’s Imuldosa, a biosimilar to Stelara
21 October 2024 - Dong-A ST announced on 18 October 2024 that its biosimilar Imuldosa (ustekinumab, development code DMB-3115), referencing ...
Posted by Michael Wonder on 22 Oct 2024
Highlights from the 14-17 October 2024 CHMP meeting
18 October 2024 - The CHMP recommended granting a marketing authorisation for Alhemo (concizumab), a medicine for routine prophylaxis of ...
Posted by Michael Wonder on 21 Oct 2024
Wainzua (eplontersen) recommended for approval in the EU by CHMP for the treatment of adult patients with polyneuropathy associated with hereditary transthyretin-mediated amyloidosis
21 October 2024 - Recommendation based on NEURO-TTRansform Phase 3 results showing Wainzua demonstrated consistent and sustained benefit improving neuropathy ...
Posted by Michael Wonder on 18 Oct 2024
Alhemo recommended for European approval as first once daily subcutaneous prophylactic treatment for people living with haemophilia A or B with inhibitors
18 October 2024 - Novo Nordisk today announced that the EMA's CHMP has adopted a positive opinion, recommending approval of ...
Posted by Michael Wonder on 18 Oct 2024
Novartis receives positive CHMP opinion for Kisqali to help reduce risk of recurrence in people with HR+/HER2- early breast cancer
18 October 2024 - Recommendation is based on the Phase 3 NATALEE trial, where Kisqali added to endocrine therapy significantly reduced ...
Posted by Michael Wonder on 17 Oct 2024
Alnylam submits regulatory application to the EMA for vutrisiran for the treatment of ATTR amyloidosis with cardiomyopathy
16 October 2024 - Type II variation submission based on the positive HELIOS-B Phase 3 trial in which vutrisiran significantly reduced ...
Posted by Michael Wonder on 17 Oct 2024
Bayer submits EU marketing authorization application for elinzanetant to treat moderate to severe vasomotor symptoms
15 October 2024 - EMA submission is based on data from Phase 3 OASIS development program for elinzanetant. ...
Posted by Michael Wonder on 17 Oct 2024
EMA publishes agenda for 14-17 October 2024 CHMP meeting
14 October 2024 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 15 Oct 2024
Bayer submits application for third indication of darolutamide in the EU
14 October 2024 - Submission is based on positive results from the pivotal Phase 3 ARANOTE trial, which showed that darolutamide ...
Posted by Michael Wonder on 11 Oct 2024
Novavax's updated 2024-2025 Nuvaxovid COVID-19 vaccine receives authorisation in the EU
9 October 2024 - Novavax today announced that the European Commission granted marketing authorisation for Novavax's updated 2024-2025 Nuvaxovid COVID-19 vaccine ...
Posted by Michael Wonder on 11 Oct 2024
Johnson & Johnson submits application to the EMA for Darzalex (daratumumab) SC based quadruplet regimen for newly diagnosed multiple myeloma patients
10 October 2024 - Submission supported by data from the Phase 3 CEPHEUS study for the treatment of patients with newly ...