Blog
RSS FeedPosted by Michael Wonder on 18 Oct 2024
Alhemo recommended for European approval as first once daily subcutaneous prophylactic treatment for people living with haemophilia A or B with inhibitors
18 October 2024 - Novo Nordisk today announced that the EMA's CHMP has adopted a positive opinion, recommending approval of ...
Posted by Michael Wonder on 20 Aug 2020
EMA agrees to review UCB's bimekizumab
18 August 2020 - Information about marketing authorisation application to EMA not yet disclosed by UCB. ...
Posted by Michael Wonder on 02 Apr 2020
Seqirus announces positive CHMP Opinion for its adjuvanted quadrivalent influenza vaccine
31 March 2020 - Seqirus today announced that its adjuvanted quadrivalent influenza vaccine - launching as Fluad Tetra - has received ...
Posted by Michael Wonder on 21 Jan 2020
European Commission approves Roche’s Polivy for people with previously treated aggressive lymphoma
21 January 2020 - Novel combination regimen includes first-in-class antibody-drug conjugate that specifically targets CD79b. ...
Posted by Michael Wonder on 24 Feb 2019
Shionogi receives European Union Marketing Authorisation for lusutrombopag for the treatment of severe thrombocytopenia in adults with chronic liver disease undergoing invasive procedures
22 February 2019 - The approval of lusutrombopag is based on two pivotal Phase 3 randomised clinical trials, L-PLUS1 and L-PLUS2. ...
Posted by Michael Wonder on 22 Sep 2017
Market approval for drugs in the EU: time to change direction?
22 September 2017 - Since 1995, the EMA has been the EU authority responsible for assessing the efficacy, safety and ...
Posted by Michael Wonder on 03 Sep 2017
European Commission approves expanded use of Mimpara (cinacalcet) for the treatment of secondary hyperparathyroidism in children with end-stage renal disease on dialysis
31 August 2017 - Amgen today announced that the European Commission has granted marketing authorisation of a paediatric formulation (granules in ...
Posted by Michael Wonder on 29 Jul 2017
European Commission grants AbbVie's Maviret (glecaprevir/pibrentasvir) marketing authorisation for the treatment of chronic hepatitis C in all major genotypes (GT1-6)
28 July 2017 - AbbVie's investigational, pan-genotypic HCV treatment is also under priority review by the U.S. FDA. ...
Posted by Michael Wonder on 22 Jul 2017
AbbVie receives CHMP positive opinion for Humira (adalimumab) for the treatment of paediatric patients with chronic non-infectious anterior uveitis
21 July 2017 - The CHMP opinion is based on results from SYCAMORE, an investigator-initiated clinical trial. ...
Posted by Michael Wonder on 02 Jun 2017
European Commission approves Brineura (cerliponase alfa), the first treatment for CLN2 disease, a form of Batten disease and ultra-rare brain disorder in children
1 June 2017 - Dosing includes all ages from birth for this fatal and rapid paediatric neurodegenerative condition Brineura is ...
Posted by Michael Wonder on 02 Mar 2017
Alnylam receives European Medicines Agency PRIME designation for accelerated assessment of givosiran, an investigational RNAi therapeutic for the treatment of acute hepatic porphyrias
1 March 2017 - Alnylam Pharmaceuticals announced today that the EMA has granted access to its Priority Medicines (PRIME) scheme ...
Posted by Michael Wonder on 13 Nov 2016
How big data can be used for the development and regulation of medicines
8 November 2016 - EMA workshop broadcast live on 14-15 November. ...
Posted by Michael Wonder on 09 Oct 2016
EMA Management Board: highlights of October 2016 meeting
7 October 2016 - Board elects Grzegorz Cessak as vice-chair, adopts Agency’s mid-year report and signs off reflection paper on ...