Blog
RSS FeedPosted 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 28 Mar 2024
89bio receives EMA PRIME status for pegozafermin in the treatment of metabolic dysfunction-associated steatohepatitis (MASH) with fibrosis and compensated cirrhosis
27 March 2024 - PRIME status is supported by positive data from the Phase 2b ENLIVEN trial of pegozafermin. ...
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 ...
Posted by Michael Wonder on 24 Mar 2024
Highlights from the 18-21 March 2024 CHMP meeting
22 March 2024 - The EMA’s human medicines committee (CHMP) recommended 12 medicines for approval at its March 2024 meeting. ...
Posted by Michael Wonder on 23 Mar 2024
Deliberations at the CHMP regarding the marketing authorisation application in the EU for lecanemab have been rescheduled due to procedural reasons at the EMA
22 March 2024 - Eisai announced today that the oral explanation scheduled for 19 March at the CHMP for lecanemab, ...
Posted by Michael Wonder on 22 Mar 2024
Astellas receives positive CHMP opinion for Xtandi in additional recurrent early prostate cancer treatment setting
22 March 2024 - If approved, XTANDI would become the first and only NHT treatment available for metastatic and high risk ...
Posted by Michael Wonder on 22 Mar 2024
Outlook Therapeutics receives European Union positive CHMP opinion for ONS-5010 as a treatment for wet AMD
22 March 2024 - Positive opinion serves as a basis for final decision for potential authorisation from the European Commission ...
Posted by Michael Wonder on 22 Mar 2024
Novartis Fabhalta (iptacopan) receives positive CHMP opinion as first oral monotherapy for adult patients with paroxysmal nocturnal hemoglobinuria
22 March 2024 - Positive CHMP opinion based on robust Phase III data, including APPLY-PNH, demonstrating superior haemoglobin improvement in the ...
Posted by Michael Wonder on 22 Mar 2024
Awiqli (once-weekly basal insulin icodec) recommended for approval for the treatment of diabetes by the European regulatory authorities
21 March 2024 - Novo Nordisk today announced that the European Medicines Agency’s CHMP has adopted a positive opinion, recommending ...
Posted by Michael Wonder on 22 Mar 2024
UCB receives positive CHMP opinion for Bimzelx (bimekizumab) for the treatment of adults with moderate to severe hidradenitis suppurativa
22 March 2024 - Positive CHMP opinion is supported by data from the two Phase 3 studies, BE HEARD I ...
Posted by Michael Wonder on 20 Mar 2024
Accelerating stakeholder collaboration to enhance the clinical trials environment in the EU
20 March 2024 - The Accelerating Clinical Trials in the EU (ACT EU) initiative has established a multi-stakeholder platform aimed at ...