Blog
RSS FeedPosted by Michael Wonder on 18 Dec 2024
Johnson & Johnson submits application to the EMA seeking approval of a new indication for Imbruvica (ibrutinib) in adult patients with previously untreated mantle cell lymphoma who are eligible for autologous stem cell transplant
18 December 2024 - The European MCL Network Phase 3 TRIANGLE study, evaluated ibrutinib in combination with induction immunochemotherapy, both with ...
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
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 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 08 Nov 2024
Johnson & Johnson submits applications in the US and EU seeking approval of Darzalex Faspro/Darzalex as subcutaneous monotherapy for high risk smoldering multiple myeloma
8 November 2024 - If approved, Darzalex Faspro will become the first treatment option for patients with smoldering multiple myeloma at ...
Posted 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 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 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
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 ...
Posted by Michael Wonder on 11 Oct 2024
EMA confirms acceptance of marketing application for AVT03, a proposed biosimilar to Prolia and Xgeva
10 October 2024 - Alvotech announced today that the EMA has accepted a marketing authorisation application for AVT03, a proposed biosimilar ...
Posted by Michael Wonder on 09 Oct 2024
Teva Prolia (denosumab) biosimilar candidate is accepted for review by US FDA and EU EMA
8 October 2024 - TVB-009P, Teva’s proposed biosimilar to Prolia, showed Phase 3 clinical results in osteoporosis and is part of ...
Posted by Michael Wonder on 19 Sep 2024
Valneva submits label extension applications for its chikungunya vaccine Ixchiq to EMA and Health Canada
18 September 2024 - To potentially include adolescents and antibody persistence up to two years. ...
Posted by Michael Wonder on 13 Sep 2024
Johnson & Johnson seeks first EU approval of nipocalimab to treat a broad population of patients living with antibody-positive generalised myasthenia gravis
12 September 2024 - Janssen-Cilag today announced the submission of the marketing authorisation application to the EMA) seeking first approval ...