Blog
RSS FeedPosted by Michael Wonder on 30 Mar 2019
bluebird bio receives positive opinion from CHMP for Zynteglo (autologous CD34+ cells encoding βA-T87Q-globin gene) gene therapy for patients 12 years and older with transfusion-dependent β-thalassemia who do not have β0/β0 Genotype
29 March 2019 - First gene therapy recommended for approval in the EU for transfusion-dependent β-thalassemia. ...
Posted by Michael Wonder on 29 Mar 2019
Highlights from CHMP 25-28 March 2019 meeting
29 March 2019 - EMA’s human medicines committee (CHMP) adopted recommendations for one new initial marketing authorisation and three extensions ...
Posted by Michael Wonder on 29 Mar 2019
Dynavax announces European Medicines Agency accepts marketing authorisation application for Heplisav-B for prevention of hepatitis B in adults
28 March 2019 - Dynavax Technologies today announced that the EMA has accepted the Company’s marketing authorisation application for review ...
Posted by Michael Wonder on 28 Mar 2019
20 years of sampling and testing programme for medicines authorised for the EU
28 March 2019 - EMA and the European Directorate for the Quality of Medicines & Healthcare have reviewed EMA’s sampling ...
Posted by Michael Wonder on 27 Mar 2019
New EudraVigilance system improves reporting of side effects and detection of safety signals
27 March 2019 - The new and improved EudraVigilance, the European system for managing and analysing information on suspected adverse ...
Posted by Michael Wonder on 26 Mar 2019
EMA tells pharma companies to continue to prepare for UK’s withdrawal
25 March 2019 - With an extension in place that will push the UK's withdrawal from the EU back to ...
Posted by Michael Wonder on 26 Mar 2019
Alimera Sciences announces approval received in the Mutual Recognition Procedure for new indication for Iluvien in Europe
25 March 2019 - Regulatory process to now enter the national phase in which each member state finalises the label to ...
Posted by Michael Wonder on 26 Mar 2019
Forxiga approved in Europe for type 1 diabetes mellitus
25 March 2019 - Forxiga is the first oral medicine approved in Europe as an adjunct to insulin for adults ...
Posted by Michael Wonder on 26 Mar 2019
bluebird bio statement on European regulatory status of LentiGlobin
25 March 2019 - A third party press release was issued today stating that the EMA issued an approval for ...
Posted by Michael Wonder on 25 Mar 2019
EMA publishes agenda for 25-28 March CHMP meeting
25 March 2019 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted 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
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 ...