Blog
RSS FeedPosted by Michael Wonder on 08 Jun 2021
Moderna files for conditional marketing approval for its COVID-19 vaccine in adolescents in the European Union
7 June 2021 - Submission based on Phase 2/3 study of mRNA-1273 in adolescents ages 12 to less than 18 ...
Posted by Michael Wonder on 07 Jun 2021
EMA raises awareness of clinical care recommendations to manage suspected thrombosis with thrombocytopenia syndrome
7 June 2021 - EMA’s COVID-19 taskforce (COVID-ETF) is advising health care professionals in the EU to consider recommendations by learned ...
Posted by Michael Wonder on 04 Jun 2021
Advancing international collaboration on COVID-19 real world evidence and observational studies
4 June 2021 - Medicines regulators from around the world discussed the importance of global collaboration and information sharing in relation ...
Posted by Michael Wonder on 03 Jun 2021
EU regulators develop recommendations to forecast demand of medicines
3 June 2021 - The EU Executive Steering Group on Shortages of Medicines Caused by Major Events has adopted a ...
Posted by Michael Wonder on 01 Jun 2021
Additional manufacturing capacity for BioNTech/Pfizer’s COVID-19 vaccine
1 June 2021 - EMA has recommended the approval of additional manufacturing and filling lines at Pfizer’s vaccine manufacturing site in ...
Posted by Michael Wonder on 01 Jun 2021
EMA and EUnetHTA take stock of their co-operation
1 June 2021 - The EMA and the European Network for Health Technology Assessment (EUnetHTA) have published a report on ...
Posted by Michael Wonder on 30 May 2021
Diurnal receives European Commission approval for Efmody
28 May 2021 - Commercial launch anticipated in Q3 2021. ...
Posted by Michael Wonder on 30 May 2021
Calliditas announces submission of marketing authorisation application for Nefecon to the European Medicines Agency
28 May 2021 - Calliditas Therapeutics today announced that the company submitted a marketing authorisation application to the EMA for ...
Posted by Michael Wonder on 28 May 2021
First COVID-19 vaccine approved for children aged 12 to 15 in EU
28 May 2021 - EMA’s CHMP has recommended granting an extension of indication for the COVID-19 vaccine Comirnaty to include use ...
Posted by Michael Wonder on 28 May 2021
Tagrisso approved in the EU for the adjuvant treatment of patients with early stage EGFR mutated lung cancer
28 May 2021 - Approval based on unprecedented results from the ADAURA Phase 3 trial where Tagrisso reduced the risk ...
Posted by Michael Wonder on 27 May 2021
Insufficient data on use of inhaled corticosteroids to treat COVID-19
27 May 2021 - EMA’s COVID-19 taskforce is advising health care professionals that there is currently insufficient evidence that inhaled ...
Posted by Michael Wonder on 26 May 2021
EU seeks large AstraZeneca fine
26 May 2021 - A lawyer for the European Union has accused AstraZeneca of failing to respect its contract with ...
Posted by Michael Wonder on 26 May 2021
Medical device regulation comes into application
26 May 2021 - The medical device regulation, which was adopted in April 2017, changes the European legal framework for medical ...
Posted by Michael Wonder on 25 May 2021
AbbVie receives European Commission approval of Venclyxto (venetoclax) in combination with a hypomethylating agent for patients with newly diagnosed acute myeloid leukaemia who are ineligible for intensive chemotherapy
25 May 2021 - Venclyxto (venetoclax) in combination with a hypomethylating agent is a new regimen approved by the European ...
Posted by Michael Wonder on 25 May 2021
Merck receives positive EU CHMP opinion for Keytruda (pembrolizumab) in combination with chemotherapy as first-line treatment for certain patients with oesophageal cancer or HER2 negative gastro-oesophageal junction adenocarcinoma
24 May 2021 - Recommendation based on significant survival benefit demonstrated with Keytruda plus chemotherapy versus chemotherapy in Phase 3 KEYNOTE-590 ...