Blog
RSS FeedPosted by Michael Wonder on 09 Jul 2020
International regulators align positions on phase 3 COVID-19 vaccine trials
9 July 2020 - Medicines regulatory authorities from around the world have published a report today highlighting the outcomes ...
Posted by Michael Wonder on 08 Jul 2020
Lynparza approved in the EU for BRCA mutated metastatic pancreatic cancer
8 July 2020 - Only PARP inhibitor approved in this disease. ...
Posted by Michael Wonder on 07 Jul 2020
Novartis receives EC approval for Enerzair Breezhaler, including the first digital companion (sensor and app) that can be prescribed alongside a treatment for uncontrolled asthma in the EU
7 July 2020 - Optional digital companion with sensor and app that provide inhalation confirmation, medication reminders and access to objective ...
Posted by Michael Wonder on 06 Jul 2020
Launch of public consultation on joint network strategy to 2025
6 July 2020 - EMA and the Heads of Medicines Agencies have developed a joint strategy for the next five ...
Posted by Michael Wonder on 06 Jul 2020
EMA validates and grants accelerated assessment for trastuzumab deruxtecan for the treatment of HER2 positive metastatic breast cancer
6 July 2020 - Daiichi Sankyo today announced that the EMA has validated the marketing authorisation application for trastuzumab deruxtecan, ...
Posted 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 ...