Blog
RSS FeedPosted by Michael Wonder on 06 Jul 2020
European Commission grants conditional marketing authorization for Gilead’s Veklury (remdesivir) for the treatment of COVID-19
3 July 2020 - Veklury is the first approved treatment option for COVID-19 in the European Union. ...
Posted by Michael Wonder on 05 Jul 2020
Oxford University is leading in the vaccine race
2 July 2020 - Governments are pouring money into a more urgent version of the space race. ...
Posted by Michael Wonder on 05 Jul 2020
European Commission approves extended Invokana (canagliflozin) indication to reflect improved renal outcomes in patients with diabetic kidney disease and type 2 diabetes seen in CREDENCE study
1 July 2020 - The European Commission approval is based on the Canagliflozin and Renal Endpoints in Diabetes with Established Nephropathy ...
Posted by Michael Wonder on 02 Jul 2020
European Commission approves Daurisma (glasdegib) for certain adult patients with newly diagnosed acute myeloid leukaemia
30 June 2020 - Pfizer today announced that the European Commission approved Daurisma (glasdegib), a Hedgehog pathway inhibitor, in combination with ...
Posted by Michael Wonder on 02 Jul 2020
Johnson & Johnson announces European Commission approval for Janssen’s preventive Ebola vaccine
1 July 2020 - This marks the first major regulatory approval of a vaccine developed by Janssen. ...
Posted by Michael Wonder on 02 Jul 2020
Rhythm Pharmaceuticals announces submission of marketing authorization application to the European Medicines Agency for setmelanotide in POMC and LEPR deficiency obesities
1 July 2020 - Company also announces positive data from eight supplemental patients, including four paediatric patients, enrolled in pivotal ...
Posted by Michael Wonder on 01 Jul 2020
International regulators provide guiding principles for COVID-19 clinical trials
1 July 2020 - EMA has endorsed a joint statement on prioritisation of COVID-19 clinical trials published by the International ...
Posted by Michael Wonder on 30 Jun 2020
EMA and Korean Ministry of Food and Drug Safety to share confidential COVID-19 information
30 June 2020 - EMA and the Ministry of Food and Drug Safety of the Republic of Korea have signed ...
Posted by Michael Wonder on 29 Jun 2020
New medicine for cystic fibrosis patients
26 June 2020 - EMA’s human medicines committee (CHMP) has recommended granting a marketing authorisation in the European Union for Kaftrio, ...
Posted by Michael Wonder on 29 Jun 2020
Samsung Bioepis receives positive CHMP opinion for Aybintio (bevacizumab)
26 June 2020 - Abbintio, a biosimilar candidate referencing Avastin (bevacizumab), is Samsung Bioepis’ second oncology biosimilar to be recommended for ...
Posted by Michael Wonder on 29 Jun 2020
Daiichi Sankyo provides update on CHMP review of pexidartinib, a CSF1R inhibitor for the treatment of patients with TGCT
26 June 2020 - Daiichi Sankyo today announced that the Committee for Medicinal Products for Human Use of the European Medicines ...
Posted by Michael Wonder on 28 Jun 2020
ERC Belgium submits marketing authorisation application to European Medicines Agency for glioblastoma immunotherapy, Sitoiganap
26 June 2020 - ERC Belgium has announced that it has submitted to the EMA its marketing authorisation application for ...
Posted by Michael Wonder on 28 Jun 2020
Highlights from the June 22-25 CHMP meeting
26 June 2020 - EMA’s human medicines committee (CHMP) recommended eight medicines for approval at its June 2020 meeting. ...
Posted by Michael Wonder on 28 Jun 2020
Hansa Biopharma receives positive CHMP opinion for Idefirix (imlifidase) for kidney transplant in EU
25 June 2020 - The positive opinion marks an important milestone as the Company prepares its transformation into a commercial stage ...
Posted by Michael Wonder on 28 Jun 2020
Novartis pulls dry eye drug Xiidra's bid for approval in Europe
27 June 2020 - Swiss drugmaker Novartis has withdrawn an application for European approval of its Xiidra dry eye medicine ...