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RSS FeedPosted by Michael Wonder on 19 Aug 2023
EMA accepts Leo Pharma’s marketing authorisation application for delgocitinib cream in chronic hand eczema
18 August 2023 - Leo Pharma is developing delgocitinib cream for the treatment of moderate to severe chronic hand eczema, ...
Posted by Michael Wonder on 17 Aug 2023
European Medicines Agency accepts Iveric Bio’s marketing authorisation application for avacincaptad pegol for geographic atrophy
18 August 2023 - Astellas Pharma today announced the EMA has accepted for regulatory review the marketing authorisation application for ...
Posted by Michael Wonder on 17 Aug 2023
Odronextamab receives EMA filing acceptance for treatment of relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma
17 August 2023 - Regeneron Pharmaceuticals today announced that the EMA has accepted for review the marketing authorisation application for odronextamab ...
Posted by Michael Wonder on 28 Jul 2023
Janssen submits supplemental new drug application to US FDA seeking expanded paediatric indication for HIV-1 therapy Edurant
28 July 2023 - Parallel application also submitted to European Medicines Agency. ...
Posted by Michael Wonder on 18 Jul 2023
Roche withdraws type II variation for Gazyvaro
18 July 2023 - The EMA has published the letter from Roche on its website. ...
Posted by Michael Wonder on 18 Jul 2023
UCB announces EU regulatory filing for bimekizumab for the treatment of moderate to severe hidradenitis suppurativa
18 July 2023 - Regulatory filing supported by data from two bimekizumab Phase 3 studies in hidradenitis suppurativa. ...
Posted by Michael Wonder on 15 Jul 2023
European Medicine Agency accepts Intas' marketing authorisation application for DMB-3115, a proposed biosimilar to Stelara (ustekinumab)
14 July 2023 - Therapeutic equivalence and safety confirmed between DMB-3115 and Stelara in global Phase 3 trial. ...
Posted by Michael Wonder on 14 Jul 2023
European Medicines Agency accepts Astellas' marketing authorisation application for zolbetuximab
13 July 2023 - Astellas Pharma today announced the EMA has accepted for regulatory review the company's marketing authorisation application for ...
Posted by Michael Wonder on 13 Jul 2023
Dr. Reddy’s proposed rituximab biosimilar application accepted for review by US FDA, EMA and MHRA
12 July 2023 - Following dossier submission in April 2023, the regulatory agencies have now accepted the dossier for review. ...
Posted by Michael Wonder on 04 Jul 2023
Moderna submits regulatory application to the EMA for its updated COVID-19 vaccine
3 July 2023 - The filing follows the recommendation from regulators and global public health bodies to develop monovalent XBB.1.5 COVID-19 ...
Posted by Michael Wonder on 28 Jun 2023
Merck, Ridgeback withdraw COVID drug application in EU
27 June 2023 - Merck and partner Ridgeback Biotherapeutics said on Tuesday they had withdrawn their COVID-19 pill application in ...
Posted by Michael Wonder on 28 Jun 2023
Bristol Myers Squibb receives European Commission approval of Camzyos (mavacamten) for the treatment of symptomatic obstructive hypertrophic cardiomyopathy
26 June 2023 - Approval based on two positive Phase 3 trials, EXPLORER-HCM and VALOR-HCM, demonstrating significant benefit in patients ...
Posted by Michael Wonder on 27 Jun 2023
Janssen submits marketing authorisation application to the EMA seeking approval of single tablet combination therapy of macitentan and tadalafil for treatment of patients with pulmonary arterial hypertension
26 June 2023 - This is the first and only single tablet combination therapy to be submitted for review in Europe ...
Posted by Michael Wonder on 25 Jun 2023
Use of real world evidence in regulatory decision making – EMA publishes review of its studies
23 June 2023 - Real world evidence from studies led by regulators can complement evidence from other sources including clinical trials. ...
Posted by Michael Wonder on 24 Jun 2023
Leo Pharma receives positive CHMP opinion for new Adtralza (tralokinumab) injection device
23 June 2023 - CHMP recommends approval of the Adtralza pre-filled pen. ...