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RSS FeedPosted by Michael Wonder on 27 Jul 2022
AbbVie submits regulatory applications to FDA and EMA for upadacitinib (Rinvoq) in Crohn's disease
27 July 2022 - Submissions are supported by three Phase 3 clinical trials demonstrating upadacitinib achieved the co-primary endpoints of clinical ...
Posted by Michael Wonder on 25 Jul 2022
Applications for proposed first of a kind multiple sclerosis biosimilar natalizumab accepted by US FDA and EMA
25 July 2022 - Submission of proposed biosimilar supported by comprehensive package; aims to expand treatment access for people with multiple ...
Posted by Michael Wonder on 20 Jul 2022
Pfizer and BioNTech complete submission to European Medicines Agency for Omicron BA.1 adapted bivalent vaccine candidate
19 July 2022 - Pfizer and BioNTech today announced they have completed a submission to the EMA for an Omicron-adapted bivalent ...
Posted by Michael Wonder on 19 Jul 2022
Genmab announces that AbbVie will submit marketing authorisation application to EMA for epcoritamab for the treatment of relapsed/refractory diffuse large B-cell lymphoma
18 July 2022 - Genmab today announced that AbbVie will submit a conditional marketing authorisation application with the EMA for ...
Posted by Michael Wonder on 19 Jul 2022
EU regulator reviews Pfizer-BioNTech COVID shot in children as young as 6 months
18 July 2022 - The European Medicines Agency on Monday started reviewing a low-dose version of BioNTech and Pfizer’s COVID-19 ...
Posted by Michael Wonder on 18 Jul 2022
EMA validates marketing authorisation application for trastuzumab duocarmazine (SYD985) in HER2 positive metastatic breast cancer
18 July 2022 - Submission follows positive results of Phase 3 TULIP trial. ...
Posted by Michael Wonder on 18 Jul 2022
AbbVie submits marketing authorisation application to EMA for atogepant for the preventive treatment of migraine
18 July 2022 - The submission is based on two pivotal Phase 3 studies evaluating atogepant in adult patients with episodic ...
Posted by Michael Wonder on 16 Jul 2022
Polpharma Biologics announces EMA acceptance of marketing authorisation application for proposed biosimilar natalizumab
14 July 2022 - Polpharma Biologics announced today that the EMA has accepted the first-ever marketing authorisation application for biosimilar natalizumab, ...
Posted by Michael Wonder on 28 Jun 2022
Monkeypox: EMA starts review for Imvanex
28 June 2022 - The EMA’s CHMP has started a review of data to extend the use of the smallpox ...
Posted by Michael Wonder on 28 Jun 2022
Curium announces the submission of its marketing authorisation application for [18F]-DCFPyL to the EMA
27 June 2022 - Submission follows the completion of Phase III PYTHON clinical trial of [18F]-DCFPyL for recurrent prostate cancer in ...
Posted by Michael Wonder on 22 Jun 2022
Trastuzumab deruxtecan type II variation application validated by EMA for patients with HER2 low metastatic breast cancer with HR positive and HR negative disease
22 June 2022 - Application based on DESTINY-Breast04 results that showed Daiichi Sankyo and AstraZeneca’s trastuzumab deruxtecan demonstrated superior progression-free and ...
Posted by Michael Wonder on 21 Jun 2022
European Medicines Agency validates Bristol Myers Squibb’s application for CAR T-cell therapy Breyanzi in relapsed or refractory large B-cell lymphoma after first-line therapy
20 June 2022 - Application based on Phase 3 TRANSFORM study in which Breyanzi outperformed the current standard of care ...
Posted by Michael Wonder on 19 Jun 2022
Start of rolling review for adapted Spikevax COVID-19 vaccine
17 June 2022 - EMA has started a rolling review for a version of Spikevax adapted to provide better protection ...
Posted by Michael Wonder on 17 Jun 2022
Sandoz application for proposed biosimilar adalimumab’s high concentration formulation accepted by EMA
17 June 2022 - Submission supported by comprehensive analytical and clinical data from new Phase I bridging pharmacokinetics study. ...
Posted by Michael Wonder on 15 Jun 2022
Start of rolling review for adapted Comirnaty COVID-19 vaccine
15 June 2022 - EMA has started a rolling review for a version of Comirnaty adapted to provide better protection ...