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RSS FeedPosted by Michael Wonder on 24 Aug 2021
European Commission approves Rinvoq (upadacitinib) as first JAK inhibitor in the European Union for the treatment of both adults and adolescents with moderate to severe atopic dermatitis
24 August 2021 - Approval supported by data from one of the largest registrational Phase 3 programs in atopic dermatitis evaluating ...
Posted by Michael Wonder on 24 Aug 2021
UCB announces European Commission approval of Bimzelx (bimekizumab) for the treatment of adults with moderate to severe plaque psoriasis
24 August 2021 - The approval in the European Union represents the first marketing authorisation for UCB’s new psoriasis treatment worldwide. ...
Posted by Michael Wonder on 23 Aug 2021
Europe has its first Lucentis biosimilar, Samsung Bioepis’ Byooviz
23 August 2021 - Novartis and Roche’s big-selling eye drug Lucentis has its first biosimilar competitor in Europe, after the ...
Posted by Michael Wonder on 23 Aug 2021
Xeljanz (tofacitinib citrate) receives marketing authorisation in the European Union for the treatment of active polyarticular juvenile idiopathic arthritis and juvenile psoriatic arthritis
20 August 2021 - Pfizer announced today that the European Commission has approved Xeljanz (tofacitinib) for the treatment of active polyarticular ...
Posted by Michael Wonder on 20 Aug 2021
Astellas receives European Commission approval for first in class Evrenzo (roxadustat) for adult patients with symptomatic anaemia of chronic kidney disease
20 August 2021 - Roxadustat is the first orally administered hypoxia-inducible factor prolyl hydroxylase inhibitor available for adult patients with anaemia ...
Posted by Michael Wonder on 19 Aug 2021
EMA validates Gilead’s marketing authorisation application for lenacapavir, an investigational, long-acting capsid inhibitor for the treatment of HIV-1 in people with limited therapy options
19 August 2021 - EMA MAA validation follows submission of NDA for Lenacapavir to the U.S. FDA. ...
Posted by Michael Wonder on 17 Aug 2021
EMA validates Bristol Myers Squibb’s applications for Opdivo (nivolumab) and Yervoy (ipilimumab) and Opdivo and chemotherapy as first-line treatments for unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma
17 August 2021 - Applications based on positive results from the Phase 3 CheckMate-648 trial, in which both Opdivo-based combinations demonstrated ...
Posted by Michael Wonder on 16 Aug 2021
EMA starts evaluating use of RoActemra in hospitalised adults with severe COVID-19
16 August 2021 - EMA has started evaluating the anti-inflammatory medicine RoActemra (tocilizumab) to extend its use to include treatment ...
Posted by Michael Wonder on 16 Aug 2021
Artificial intelligence in medicine regulation
16 August 2021 - The International Coalition of Medicines Regulatory Authorities sets out recommendations to help regulators to address the ...
Posted by Michael Wonder on 09 Aug 2021
Forxiga approved in the EU for the treatment of chronic kidney disease in patients with and without type 2 diabetes mellitus
9 August 2021 - Approval based on unprecedented DAPA-CKD Phase 3 data is the most significant advancement in chronic kidney ...
Posted by Michael Wonder on 06 Aug 2021
Interoperability of track and trace systems: key to public health protection
6 August 2021 - EMA has endorsed recommendations developed by the International Coalition of Medicines Regulatory Authorities to facilitate the use ...
Posted by Michael Wonder on 03 Aug 2021
Amicus Therapeutics announces European Commission approval of Galafold (migalastat) for adolescents with Fabry disease
2 August 2021 - Galafold is the first and only oral therapy approved in the EU for the long-term treatment of ...
Posted by Michael Wonder on 02 Aug 2021
Bristol Myers Squibb receives European Commission approval for Opdivo (nivolumab) as adjuvant treatment for oesophageal or gastro-oesophageal junction cancer patients with residual pathologic disease following chemoradiotherapy
30 July 2021 - Approval is based on Phase 3 results from the CheckMate-577 trial. ...
Posted by Michael Wonder on 29 Jul 2021
GSK and Vir Biotechnology announce Joint Procurement Agreement with European Commission for COVID-19 treatment sotrovimab
28 July 2021 - GSK and Vir Biotechnology today announced they have signed a Joint Procurement Agreement with the European ...
Posted by Michael Wonder on 26 Jul 2021
Rhythm Pharmaceuticals announces European Commission authorisation of Imcivree (setmelanotide) for the treatment of obesity and control of hunger associated with POMC, PCSK1 and LEPR deficiency
23 July 2021 - First ever authorised treatment option in the European Union for these rare genetic diseases of obesity. ...