Blog
RSS FeedPosted by Michael Wonder on 23 Jun 2022
EMA recommends authorisation of Nuvaxovid for adolescents aged 12 to 17
23 June 2022 - EMA’s CHMP has recommended granting an extension of indication for the COVID-19 vaccine Nuvaxovid to include use ...
Posted by Michael Wonder on 09 Jun 2022
Bydureon BCise (exenatide prolonged-release) approved in the EU for paediatric patients with type 2 diabetes
8 June 2022 - First once weekly GLP-1 treatment option for paediatric patients with type-2 diabetes in the EU. ...
Posted by Michael Wonder on 21 May 2022
PTC Therapeutics receives positive CHMP opinion for Upstaza for the treatment of AADC deficiency
20 May 2022 - First ever gene therapy directly administered into the brain. ...
Posted by Michael Wonder on 20 May 2022
Novartis Cosentyx (secukinumab) receives positive CHMP opinion for expanded use in childhood arthritic conditions
20 May 2022 - Positive opinion could expand the role of Cosentyx (secukinumab) in reducing flare risk in paediatric enthesitis-related arthritis ...
Posted by Michael Wonder on 07 Apr 2022
Dupixent (dupilumab) approved by European Commission for children aged 6 to 11 years with severe asthma with type 2 inflammation
7 April 2022 - Approval based on Phase 3 data showing Dupixent significantly reduced severe asthma attacks and also improved lung ...
Posted by Michael Wonder on 31 Mar 2022
Novavax submits request to expand conditional marketing authorisation of COVID-19 vaccine in the European Union to adolescents (ages 12-17)
31 March 2022 - If granted, Nuvaxovid COVID-19 vaccine (recombinant, adjuvanted) would be the first protein-based option for adolescents aged ...
Posted by Michael Wonder on 24 Feb 2022
EMA recommends authorisation of booster doses of Comirnaty from 12 years of age
24 February 2022 - EMA’s CHMP has recommended that a booster dose of the COVID-19 vaccine Comirnaty may be given where ...
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 08 Feb 2022
EMA evaluating data on booster dose of COVID-19 vaccine Comirnaty in adolescents
8 February 2022 - EMA has started evaluating an application for the use of a booster dose of Comirnaty (BioNTech/Pfizer’s vaccine) ...
Posted by Michael Wonder on 31 Jan 2022
CHMP recommends approval of Dupixent (dupilumab) for children aged 6 to 11 years with severe asthma with type 2 inflammation
31 January 2022 - Recommendation based on pivotal trial that showed Dupixent significantly reduced severe asthma attacks and improved lung function ...
Posted by Michael Wonder on 16 Jan 2022
Ascendis Pharma receives European Approval for TransCon hGH for paediatric growth hormone deficiency
13 January 2022 - TransCon hGH (approved by the European Commission as Lonapegsomatropin Ascendis Pharma) is a once-weekly prodrug of somatropin ...
Posted by Michael Wonder on 26 Dec 2021
Pfizer and BioNTech submit updated longer-term follow-up data of Comirnaty in adolescents 12 through 15 years of age to EMA
23 December 2021 - Pfizer and BioNTech today announced that they have submitted longer-term follow-up data from the companies’ pivotal Phase ...
Posted by Michael Wonder on 25 Nov 2021
Comirnaty COVID-19 vaccine: EMA recommends approval for children aged 5 to 11
25 November 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 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 10 Nov 2021
EMA starts evaluating use of COVID-19 vaccine Spikevax in children aged 6 to 11
10 November 2021 - EMA has started evaluating an application to extend the use of Moderna’s COVID-19 vaccine, Spikevax, to ...