Blog
RSS FeedPosted by Michael Wonder on 20 Nov 2021
EMA issues advice on use of Lagevrio (molnupiravir) for the treatment of COVID-19
19 November 2021 - EMA’s CHMP has issued advice on the use of Lagevrio (molnupiravir, MK 4482) for the treatment of ...
Posted by Michael Wonder on 20 Nov 2021
EMA starts review of Paxlovid for treating patients with COVID-19
19 November 2021 - EMA is reviewing currently available data on the use of Paxlovid (PF-07321332/ritonavir), an oral treatment for COVID-19 ...
Posted by Michael Wonder on 17 Nov 2021
AbbVie expands immunology portfolio in the European Union with the European Commission approval of Skyrizi (risankizumab) for the treatment of adults with active psoriatic arthritis
17 November 2021 - Approval supported by data from two Phase 3 studies evaluating Skyrizi in psoriatic arthritis patients, KEEPsAKE-1 and ...
Posted by Michael Wonder on 17 Nov 2021
European Commission approves Nucala (mepolizumab) in three additional eosinophil-driven diseases
17 November 2021 - Approval for the first targeted treatment for eosinophilic granulomatosis with polyangiitis and the first anti-IL-5 biologic treatment ...
Posted by Michael Wonder on 17 Nov 2021
EMA receives application for conditional marketing authorisation of Novavax’s COVID-19 vaccine, Nuvaxovid
17 November 2021 - EMA has started evaluating an application for conditional marketing authorisation for Novavax’s COVID-19 vaccine, Nuvaxovid (also known ...
Posted by Michael Wonder on 16 Nov 2021
Pre-approval and post-approval availability of evidence and clinical benefit of conditionally approved cancer drugs in Europe: a comparison with standard approved cancer drugs
15 November 2021 - Cancer drugs are increasingly approved through expedited regulatory pathways including the European conditional marketing authorisation. ...
Posted by Michael Wonder on 16 Nov 2021
CARsgen announces CAR T-cell product candidate CT041 granted PRIME eligibility by the EMA
15 November 2021 - CARsgen Therapeutics today announced that the EMA has granted Priority Medicines (PRIME) eligibility to CT041 for the ...
Posted by Michael Wonder on 15 Nov 2021
Celltrion’s monoclonal antibody treatment regdanvimab, approved by the European Commission for the treatment of COVID-19
14 November 2021 - The European Commission granted marketing authorisation for Celltrion’s regdanvimab following positive opinion by the EMA's CHMP last ...
Posted by Michael Wonder on 15 Nov 2021
Horizon Therapeutics receives CHMP positive opinion for Uplinza (inebilizumab) as a monotherapy for the treatment of adult patients with neuromyelitis optica spectrum disorder
12 November 2021 - CHMP recommendation based on positive results from N-MOmentum, the largest clinical trial ever conducted in NMOSD to ...
Posted by Michael Wonder on 15 Nov 2021
Ozempic 2 mg recommended for approval for the treatment of type 2 diabetes by the European Medicines Agency
12 November 2021 - Novo Nordisk today announced that the EMA's CHMP has adopted a positive opinion recommending a label ...
Posted by Michael Wonder on 15 Nov 2021
Wegovy recommended for approval for the treatment of obesity by the European regulatory authorities
11 November 2021 - Novo Nordisk today announced that the European Medicines Agency’s CHMP has adopted a positive opinion, recommending ...
Posted by Michael Wonder on 13 Nov 2021
Vertex receives CHMP positive opinion for Kaftrio (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor in children with cystic fibrosis ages 6 through 11
12 November 2021 - If approved, more than 1,500 children would be eligible for a medicine that can treat the ...
Posted by Michael Wonder on 13 Nov 2021
Highlights from CHMP 8-11 November 2021 meeting
12 November 2021 - EMA’s CHMP recommended eleven medicines for approval at its November 2021 meeting. ...
Posted by Michael Wonder on 12 Nov 2021
First in class medicine recommended for treatment of rare blood vessel inflammation
12 November 2021 - EMA has recommended granting a marketing authorisation in the European Union for Tavneos (avacopan), a first in ...
Posted by Michael Wonder on 11 Nov 2021
Valneva receives EU deal for COVID jab, and seeks apology from UK
11 November 2021 - French vaccine manufacturer, Valneva, has announced that it has won EU approval to supply up to 60 ...