Blog
RSS FeedPosted by Michael Wonder on 25 Feb 2022
Protalix BioTherapeutics and Chiesi Global Rare Diseases announce the submission of a marketing authorisation application to the European Medicines Agency for PRX-102 for the treatment of Fabry disease
24 February 2022 - Protalix BioTherapeutics and Chiesi Global Rare Diseases today announced the submission of a marketing authorisation application via ...
Posted by Michael Wonder on 22 Feb 2022
European medicines regulatory network adopts EU common standard for electronic product information
22 February 2022 - The European Medicines Regulatory Network has adopted a Common Standard for the electronic product information on medicines ...
Posted by Michael Wonder on 22 Feb 2022
BeiGene announces European Medicines Agency acceptance of applications for Brukinsa (zanubrutinib) in chronic lymphocytic leukaemia and marginal zone lymphoma
22 February 2022 - The CLL filing is supported by two global Phase 3 trials of Brukinsa in chronic lymphocytic leukaemia ...
Posted by Michael Wonder on 22 Feb 2022
Celltrion's auto-immune disease biosimilar wins further approval in Europe
22 February 2022 - South Korean pharmaceutical giant Celltrion said Tuesday that a high concentration version of its auto-immune disease ...
Posted by Michael Wonder on 21 Feb 2022
Bayer’s new treatment Kerendia (finerenone) approved in EU for adult patients with chronic kidney disease associated with type 2 diabetes
21 February 2022 - Kerendia is the first non-steroidal, selective mineralocorticoid receptor antagonist to demonstrate positive kidney and cardiovascular outcomes in ...
Posted by Michael Wonder on 18 Feb 2022
Regulatory decisions diverge over aducanumab for Alzheimer’s disease
19 February 2022 - The EMA refused marketing authorisation for aducanumab (Aduhelm), a monoclonal antibody targeted at amyloid β, in December ...
Posted by Michael Wonder on 18 Feb 2022
European Commission approves Tepmetko (tepotinib) for patients with advanced NSCLC with METex14 skipping alterations
18 February 2022 - Approval is based on Phase II results from VISION, the largest interventional study to date of patients ...
Posted by Michael Wonder on 17 Feb 2022
Nirsevimab EMA regulatory submission accepted under accelerated assessment for RSV protection in all infants
17 February 2022 - Nirsevimab is the first investigational long-acting antibody designed to protect all infants for the respiratory syncytial ...
Posted by Michael Wonder on 16 Feb 2022
European Commission approves Oxbryta (voxelotor) for the treatment of haemolytic anaemia in patients with sickle cell disease age 12 years and older
16 February 2022 - The first sickle haemoglobin polymerisation inhibitor approved in Europe, Oxbryta increases haemoglobin levels and reduces sickling ...
Posted by Michael Wonder on 16 Feb 2022
Merck struggles to win European approval for Covid antiviral pill
16 February 2022 - EMA said to be unlikely to grant marketing authorisation to molnupiravir this month after ‘problematic’ data. ...
Posted by Michael Wonder on 16 Feb 2022
Pfizer and OPKO’s once weekly Ngenla (somatrogon) injection receives marketing authorisation in European Union for treatment of paediatric growth hormone deficiency
15 February 2022 - Pfizer and OPKO Health announced today that the European Commission has granted marketing authorisation for the next ...
Posted by Michael Wonder on 16 Feb 2022
Saphnelo approved in the EU for the treatment of moderate to severe systemic lupus erythematosus
16 February 2022 - Saphnelo is a first in class type I interferon receptor antibody and the only new medicine ...
Posted by Michael Wonder on 15 Feb 2022
Human medicines: highlights of 2021
15 February 2022 - In 2021, EMA recommended 92 medicines for marketing authorisation. Of these, 53 had a new active substance ...
Posted by Michael Wonder on 14 Feb 2022
EMA starts safety review of Janus kinase inhibitors for inflammatory disorders
11 February 2022 - EMA’s safety committee, PRAC, has started a review of the safety of Janus kinase (JAK) inhibitors ...
Posted by Michael Wonder on 09 Feb 2022
EU ramps up collection of public health data to improve drug reviews
9 February 2022 - By 2025, centre is set to conduct over 100 studies per year. ...