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RSS FeedPosted by Michael Wonder on 23 Apr 2024
European Commission approves Pfizer’s Emblaveo for patients with multidrug-resistant infections and limited treatment options
22 April 2024 - Emblaveo was reviewed under EMA accelerated assessment procedure, used when a pharmaceutical product is of major ...
Posted by Michael Wonder on 22 Apr 2024
Carvykti (ciltacabtagene autoleucel) is the first BCMA targeted treatment approved by the European Commission for patients with relapsed and refractory multiple myeloma who have received at least one prior line of therapy
22 April 2024 - Approval is based on results from the Phase 3 CARTITUDE-4 study, in which treatment with ciltacabtagene autoleucel ...
Posted by Michael Wonder on 22 Apr 2024
EMA publishes agenda for 22-25 April 2024 CHMP meeting
22 April 2024 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 22 Apr 2024
Sandoz confirms European Commission approval of Pyzchiva (ustekinumab), further strengthening immunology offering
22 April 2024 - EC approval based on robust development program confirming match to reference medicine in terms of safety, ...
Posted by Michael Wonder on 22 Apr 2024
UCB receives European Commission approval for Bimzelx (bimekizumab) as the first IL-17A and IL-17F biologic for moderate to severe hidradenitis suppurativa
22 April 2024 - Approval is supported by data from two Phase 3 studies, BE HEARD I and BE HEARD ...
Posted by Michael Wonder on 18 Apr 2024
COVID-19 vaccine strain updates: global regulators agree on timing and data requirements
17 April 2024 - International regulators have published a report today presenting the outcomes of a workshop on COVID-19 vaccine ...
Posted by Michael Wonder on 08 Apr 2024
EMA says it will consider conditional approval for NASH drugs using intermediate outcomes
5 April 2024 - The EMA said in a new reflection paper that it will consider granting conditional marketing approval ...
Posted by Michael Wonder on 04 Apr 2024
Rocket Pharmaceuticals announces EMA acceptance of RP-L102 marketing authorisation application for the treatment of Fanconi anaemia
2 April 2024 - Positive, previously disclosed results from the global Phase 1/2 trial demonstrated genetic and phenotypic correction combined ...
Posted by Michael Wonder on 03 Apr 2024
Autolus Therapeutics announces acceptance of marketing authorisation application by the EMA for obecabtagene autoleucel for patients with relapsed/refractory adult B-cell acute lymphoblastic leukaemia
2 April 2024 - Submission includes results from pivotal Phase 2 FELIX study evaluating obe-cel in r/r B-ALL. ...
Posted by Michael Wonder on 03 Apr 2024
European Commission expands approval of Bristol Myers Squibb’s Reblozyl (luspatercept) to include first-line treatment of transfusion-dependent anaemia in adults with lower-risk myelodysplastic syndromes
2 April 2024 - Approval of Reblozyl is based on head-to-head, pivotal Phase 3 COMMANDS study, in which Reblozyl nearly doubled ...
Posted by Michael Wonder on 29 Mar 2024
PTC announces submission of sepiapterin MAA for treatment of PKU to EMA
28 March 2024 - First marketing authorisation submission for sepiapterin with additional global submissions to follow in 2024. ...
Posted by Michael Wonder on 28 Mar 2024
Abilify Maintena 960 mg (aripiprazole) approved in the EU as the first once every two months long-acting injectable for the maintenance treatment of schizophrenia
27 March 2024 - Otsuka Pharmaceutical announces that its subsidiary Otsuka Pharmaceutical Europe and Lundbeck announced that the European Commission ...
Posted by Michael Wonder on 28 Mar 2024
European Commission approves Merck’s Keytruda (pembrolizumab) plus chemotherapy as neo-adjuvant treatment, then continued as monotherapy as adjuvant treatment, for resectable non-small cell lung cancer at high risk of recurrence in adults
28 March 2024 - Decision marks the first approval in Europe for an anti-PD-1/L1 therapy in resectable non-small cell lung ...
Posted by Michael Wonder on 27 Mar 2024
Norgine receives positive CHMP opinion recommending approval of NPJ5008 (dantrolene sodium hemiheptahydrate) for the treatment of malignant hyperthermia
26 March 2024 - Norgine today announced that the CHMP of the EMA has adopted a positive opinion recommending approval of ...
Posted by Michael Wonder on 27 Mar 2024
EU recommendations for 2024/2025 seasonal flu vaccine composition
26 March 2024 - EMA has issued recommendations for the influenza virus strains that vaccine manufacturers should include in vaccines for ...