Blog
RSS FeedPosted by Michael Wonder on 02 Jun 2018
Sandoz receives positive CHMP opinion for proposed biosimilar adalimumab
1 June 2018 - Sandoz is seeking approval of proposed biosimilar adalimumab for use in all reference medicine indications including those ...
Posted by Michael Wonder on 02 Jun 2018
Novartis receives positive CHMP opinion for Aimovig (erenumab) for the prevention of migraine
1 June 2018 - If approved, Aimovig (erenumab) is expected to be the first and only available therapy designed specifically for ...
Posted by Michael Wonder on 01 Jun 2018
EMA restricts use of Keytruda and Tecentriq in bladder cancer
1 June 2018 - Data show lower survival in some patients with low levels of cancer protein PD-L1. ...
Posted by Michael Wonder on 29 May 2018
Clovis Oncology announces European Commission authorisation of Rubraca (rucaparib) for women with recurrent ovarian cancer
29 May 2018 - First PARP inhibitor licensed for ovarian treatment indication in the EU. ...
Posted by Michael Wonder on 29 May 2018
Acorda announces EMA validation of the MAA submission for Inbrija (levodopa inhalation powder)
29 May 2018 - Acorda Therapeutics today announced that the EMA has completed formal validation of Acorda’s marketing authorisation application ...
Posted by Michael Wonder on 29 May 2018
Construction of new EMA building in Amsterdam on track
29 May 2018 - Foundation stone-laying ceremony takes place at Zuidas. ...
Posted by Michael Wonder on 29 May 2018
EMA publishes agenda for 28-31 May CHMP meeting
28 May 2018 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 29 May 2018
AB Science provides update on EU marketing authorisation application for masitinib in the treatment of amyotrophic lateral sclerosis
28 May 2018 - AB Science announces its decision not to pursue the re- examination procedure that the company initially ...
Posted by Michael Wonder on 24 May 2018
Development of antibiotics for children - towards a global approach
24 May 2018 - Workshop with regulators from EU, Japan and US open for registration ...
Posted by Michael Wonder on 24 May 2018
Sandoz receives European Commission approval for Zessly (infliximab) in gastroenterological, rheumatological and dermatological diseases
24 May 2018 - Zessly is the third EC approval for a Sandoz biosimilar in 12 months. ...
Posted by Michael Wonder on 22 May 2018
Working together for people with rare and complex diseases
22 May 2018 - Live broadcast of workshop with European Reference Networks on 29 May. ...
Posted by Michael Wonder on 22 May 2018
EMA report makes recommendations for CAR-T patient registries
22 May 2018 - A new report from the EMA lays out recommendations for improving the use of patient registries ...
Posted by Michael Wonder on 22 May 2018
ViiV Healthcare receives EU marketing authorisation for Juluca (dolutegravir/rilpivirine), the first 2-drug regimen, once-daily, single-pill for the treatment of HIV
21 May 2018 - Juluca maintains viral suppression with two drugs in the smallest single pill regimen. ...
Posted by Michael Wonder on 18 May 2018
EMA review of Zinbryta confirms medicine’s risks outweigh its benefits
18 May 2018 - Multiple sclerosis medicine no longer authorised and has been recalled from hospitals and pharmacies ...
Posted by Michael Wonder on 17 May 2018
Amgen receives European Commission Approval for Repatha (evolocumab) to prevent heart attack and stroke in adults with established cardiovascular disease
16 May 2018 - Amgen announces efforts to improve Repatha's affordability across Europe for payers who significantly expand patient access. ...