Blog
RSS FeedPosted 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 ...
Posted by Michael Wonder on 05 Sep 2024
Prilenia’s pridopidine for Huntington’s disease accepted for European marketing authorisation review
3 September 2024 - Prilenia Therapeutics announces the acceptance of its European marketing authorisation application for pridopidine (45 mg orally ...
Posted by Michael Wonder on 19 Aug 2024
Bavarian Nordic submits data to EMA to extend Mpox/smallpox vaccine approval to adolescents
16 August 2024 - Interim results from clinical study show non-inferiority of immune responses from mpox/smallpox vaccination in adolescents and ...
Posted by Michael Wonder on 19 Aug 2024
EMA validates Bristol Myers Squibb’s application for CAR T cell therapy Breyanzi for relapsed or refractory follicular lymphoma
19 August 2024 - Application based on the TRANSCEND FL trial in which Breyanzi showed deep and durable responses and a ...
Posted by Michael Wonder on 19 Aug 2024
Enhertu type II variation application validated by EMA for patients with HER2 low or HER2 ultralow metastatic breast cancer following at least one endocrine therapy
19 August 2024 - Submission based on DESTINY-Breast06 Phase 3 trial results that showed Daiichi Sankyo and AstraZeneca’s Enhertu demonstrated ...
Posted by Michael Wonder on 16 Aug 2024
EMA confirms acceptance of marketing application for AVT06, a proposed biosimilar to Eylea (aflibercept)
15 August 2024 - The approvals process is anticipated to be completed in the third quarter of 2025. ...
Posted by Michael Wonder on 16 Aug 2024
KalVista announces validation of marketing authorisation application by the EMA for sebetralstat for hereditary angioedema
15 August 2024 - KalVista Pharmaceuticals today announced that the EMA has validated the submission of a marketing authorisation application for ...
Posted by Michael Wonder on 01 Aug 2024
BioNet’s recombinant pertussis vaccine submitted to EMA
31 July 2024 - BioNet Europe has announced the submission of a centralised marketing authorisation application to the EMA for its ...