Blog
RSS FeedPosted by Michael Wonder on 28 Jun 2020
Novartis receives positive CHMP opinion for new Xolair indication to treat severe chronic rhinosinusitis with nasal polyps
26 June 2020 - Decision based on results from the Phase III POLYP 1 and 2 studies, in which omalizumab significantly ...
Posted by Michael Wonder on 28 Jun 2020
Novartis Cosentyx gains positive CHMP opinion for paediatric psoriasis, reinforcing established efficacy and safety profile
26 June 2020 - EMA CHMP positive opinion paves way for Cosentyx to become a first-line systemic treatment in paediatric psoriasis. ...
Posted by Michael Wonder on 28 Jun 2020
European Commission approves Reblozyl (luspatercept) for the treatment of transfusion-dependent anaemia in adult patients with myelodysplastic syndromes or beta thalassaemia
26 June 2020 - Reblozyl is the first and only erythroid maturation agent to be approved in the European Union, representing ...
Posted by Michael Wonder on 25 Jun 2020
First COVID-19 treatment recommended for EU authorisation
25 June 2020 - EMA’s human medicines committee has recommended granting a conditional marketing authorisation to Veklury (remdesivir) for the ...
Posted by Michael Wonder on 25 Jun 2020
Emer Cooke nominated as new EMA Executive Director
25 June 2020 - The EMA Management Board has nominated Emer Cooke as the new Executive Director of the Agency. ...
Posted by Michael Wonder on 24 Jun 2020
Global regulators discuss data requirements for phase 3 trials of COVID-19 vaccines
24 June 2020 - Under the umbrella of the International Coalition of Medicines Regulatory Authorities, international regulators discussed COVID-19 vaccine ...
Posted by Michael Wonder on 23 Jun 2020
Academia developing medicines for rare diseases to receive free EMA scientific advice
23 June 2020 - To further encourage the development of treatments for rare diseases, EMA will waive all fees for ...
Posted by Michael Wonder on 22 Jun 2020
European Commission, EMA and FDA agree new priorities to strengthen their collaboration on medicines
22 June 2020 - Senior officials from the European Commission, EMA and the United States FDA held their 2020 bilateral ...
Posted by Michael Wonder on 22 Jun 2020
European Medicines Agency validates application for Bavencio (avelumab) for first-line maintenance treatment of locally advanced or metastatic urothelial carcinoma
22 June 2020 - Merck and Pfizer today announced that the EMA has validated for review the Type II variation ...
Posted by Michael Wonder on 19 Jun 2020
Cancer Prevention Pharmaceuticals submits EU marketing authorisation application for CPP-1X/sul for treatment of familial adenomatous polyposis
18 June 2020 - Cancer Prevention Pharmaceuticals announced today that it has submitted a marketing authorisation application to the European Medicines ...
Posted by Michael Wonder on 19 Jun 2020
BeiGene announces European Medicines Agency acceptance of its marketing authorisation application for Brukinsa (zanubrutinib) for the treatment of patients with Waldenström’s macroglobulinaemia
18 June 2020 - BeiGene today announced that its marketing authorisation application for Brukinsa (zanubrutinib) for the treatment of patients with ...
Posted by Michael Wonder on 18 Jun 2020
International regulators stress value of safe and effective vaccines
18 June 2020 - EMA has endorsed two statements about the importance, safety and effectiveness of vaccines published today by the ...
Posted by Michael Wonder on 16 Jun 2020
Advancing structured decision‐making in drug regulation at the FDA and EMA
11 June 2020 - FDA’s recent benefit‐risk framework was developed for improving the clarity and consistency in communicating the reasoning behind ...
Posted by Michael Wonder on 16 Jun 2020
First drug proves able to improve survival from COVID-19, trial shows
17 June 2020 - A low-cost, widely used anti-inflammatory drug has improved survival in patients with COVID-19, scientists say, the ...
Posted by Michael Wonder on 15 Jun 2020
Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19 – update #4
15 June 2020 - The International Coalition of Medicines Regulatory Authorities convened its regular virtual meeting of regulators from around ...