Blog
RSS FeedPosted by Michael Wonder on 05 Jul 2016
Biogen and AbbVie’s once-monthly Zinbryta (daclizumab) approved in European Union for treatment of multiple sclerosis
5 July 2016 - Zinbryta significantly reduced multiple measures of disease activity in patients with relapsing forms of multiple sclerosis. ...
Posted by Michael Wonder on 04 Jul 2016
Allergan receives positive opinion through European decentralised procedure for Belkyra (deoxycholic acid) for patients with submental fullness
1 July 2016 - Belkyra (deoxycholic acid) expected to be the first non-surgical prescription medicine to treat submental fullness (or double ...
Posted by Michael Wonder on 04 Jul 2016
European Commission approves extended indication for Amgen's Kyprolis (carfilzomib) for the treatment of relapsed multiple myeloma patients
4 July 2016 - New indication allows Kyprolis to be used in combination with dexamethasone alone for appropriate patients. ...
Posted by Michael Wonder on 02 Jul 2016
EMA publishes EPAR for opicapone (Omentys)
1 June 2016 - The EMA has published an EPAR for Bial - Portela's opicapone (Omentys). ...
Posted by Michael Wonder on 30 Jun 2016
Strengthening interaction with academia
30 June 2016 - EMA consults academia in preparation of a framework of collaboration. ...
Posted by Michael Wonder on 29 Jun 2016
New antibiotic Zavicefta approved in the European Union for patients with serious bacterial infections
28 June 2016 - AstraZeneca today announced that the European Commission has granted marketing authorisation for Zavicefta (ceftazidime-avibactam, previously known as ...
Posted by Michael Wonder on 28 Jun 2016
Roche’s marketing applications for review of Ocrevus (ocrelizumab) in two forms of multiple sclerosis accepted by EMA and FDA
28 June 2016 - Ocrevus is the first investigational medicine seeking marketing authorisation for both relapsing and primary progressive multiple sclerosis. ...
Posted by Michael Wonder on 27 Jun 2016
BioMarin withdraws submission for Kyndrisa
27 June 2016 - On 31 May 2016, BioMarin officially notified the CHMP that it wishes to withdraw its application for ...
Posted by Michael Wonder on 26 Jun 2016
Brexit spells upheaval for EU and UK drug regulation
24 June 2016 - Britain's vote to leave the European Union spells regulatory uncertainty for drug companies, with the London-based EMA, ...
Posted by Michael Wonder on 26 Jun 2016
Teva receives CHMP positive opinion for Cinqaero (reslizumab)
24 June 2016 - Add-on therapy targeting IL-5 in adults with severe eosinophilic asthma pending marketing authorization in Europe. ...
Posted by Michael Wonder on 26 Jun 2016
MolMed receives positive CHMP opinion recommending conditional marketing authorisation for Zalmoxis, the first immunogene therapy to treat high-risk haematological malignancies in patients receiving haplo-identical haematopoietic stem cell transplantation
24 June 2016 - The CHMP of the EMA, in conjunction with the Committee for Advanced Therapies, has issued a ...
Posted by Michael Wonder on 24 Jun 2016
Highlights from the CHMP 20-23 June 2016 meeting
24 June 2016 - Six new medicines, including one cell-based therapy, recommended for approval. ...
Posted by Michael Wonder on 24 Jun 2016
New cell-based therapy to support stem cell transplantation in patients with high-risk blood cancer
24 June 2016 - Orphan medicine Zalmoxis recommended by CAT and CHMP for marketing authorisation ...
Posted by Michael Wonder on 24 Jun 2016
European Commission grants marketing authorization for Gilead’s single tablet regimen Odefsey (emtricitabine, rilpivirine, tenofovir alafenamide) for the treatment of HIV
23 June 2016 - Odefsey is the second single tablet regimen containing the Descovy backbone and the third product in Gilead’s ...
Posted by Michael Wonder on 23 Jun 2016
EMA publishes monthly statistics
23 June 2016 - The EMA has published a monthly statistics report on the medicinal products for human use that ...