Blog
RSS FeedPosted by Michael Wonder on 23 Mar 2019
Genmab announces European regulatory submission for daratumumab in combination with lenalidomide and dexamethasone in frontline multiple myeloma
22 March 2019 - Type II variation application submitted to the EMA for daratumumab in combination with lenalidomide and dexamethasone as ...
Posted by Michael Wonder on 19 Mar 2019
Boehringer Ingelheim announces FDA and EMA regulatory submission for nintedanib in systemic sclerosis associated ILD
18 March 2019 - Systemic sclerosis, also known as scleroderma, is a rare chronic connective tissue disease. ...
Posted by Michael Wonder on 18 Mar 2019
Praluent (alirocumab) now approved in European Union to reduce the risk of cardiovascular events in patients with established cardiovascular disease
15 March 2019 - Approval is based on ODYSSEY OUTCOMES trial of 18,924 patients who recently suffered an acute coronary syndrome ...
Posted by Michael Wonder on 16 Mar 2019
European Commission approves Roche’s MabThera (rituximab) for a rare auto-immune disease
15 March 2019 - MabThera is now approved in Europe to treat four auto-immune diseases. ...
Posted by Michael Wonder on 14 Mar 2019
An EU wide approach to HTA: an irrelevant development or an opportunity not to be missed?
14 March 2019 - An EU-wide cooperation on HTA has been proposed recently by the European Commission, focusing on relative effectiveness ...
Posted by Michael Wonder on 14 Mar 2019
European Commission approves Merck’s Keytruda (pembrolizumab) in combination with chemotherapy for first-line treatment of adults with metastatic squamous non-small cell lung cancer
14 March 2019 - European approval based on KEYNOTE-407 study results demonstrating significant improvement in overall survival with Keytruda in combination ...
Posted by Michael Wonder on 14 Mar 2019
European Commission approves Roche’s Hemlibra for people with severe haemophilia A without factor VIII inhibitors
14 March 2019 - First medicine to significantly reduce treated bleeds compared to prior factor VIII prophylaxis, in a prospective intra-patient ...
Posted by Michael Wonder on 13 Mar 2019
Advicenne announces submission of European marketing authorisation application for ADV7103 as treatment for distal renal tubular acidosis
12 March 2019 - Advicenne announces today that it has submitted a marketing authorisation application to tEMA for its lead ...
Posted by Michael Wonder on 11 Mar 2019
EMA now operating from Amsterdam
11 March 2019 - As of today, EMA is operating from Amsterdam. ...
Posted by Michael Wonder on 11 Mar 2019
Celgene submits application to EMA for ozanimod for the treatment of relapsing-remitting multiple sclerosis
11 March 2019 - New drug application submission to U.S. FDA on track for end of March. ...
Posted by Michael Wonder on 08 Mar 2019
European Medicines Agency validates application for Bavencio (avelumab) plus Inlyta (axitinib) for the treatment of advanced renal cell carcinoma
8 March 2019 - Merck and Pfizer today announced that the EMA has validated for review the Type II variation ...
Posted by Michael Wonder on 06 Mar 2019
Samsung Bioepis gains approval to sell bigger size Ontruzant in Europe
5 March 2019 - Samsung Bioepis has gained approval to sell bigger-size Ontruzant in Europe, the company said Tuesday. ...
Posted by Michael Wonder on 04 Mar 2019
European Medicines Agency adopts positive opinion for Merck’s Keytruda (pembrolizumab) for six-week dosing schedule across all current monotherapy indications
4 March 2019 - Merck today announced that the CHMP of the EMA has recommended the approval of a new ...
Posted by Michael Wonder on 04 Mar 2019
Regulatory information – adjusted fees for applications to EMA from 1 April 2019
1 March 2019 - The EMA reminds applicants and marketing authorisation holders that adjusted fees for all applications, except for ...
Posted by Michael Wonder on 04 Mar 2019
Novo Nordisk files for a label update for Fiasp to the EMA and the FDA seeking approval for use in children and adolescents
1 March 2019 - Novo Nordisk today announced that it has submitted label updates to the EMA and the US FDA ...