Blog
RSS FeedPosted 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
Bristol Myers Squibb’s Abecma (idecabtagene vicleucel) becomes first CAR T cell therapy approved in the European Union in earlier lines for triple-class exposed relapsed and refractory multiple myeloma
20 March 2024 - Abecma demonstrated superiority over standard regimens in the Phase 3 KarMMa-3 trial, with a 51% reduction in ...
Posted by Michael Wonder on 14 Mar 2024
European Commission approves Pfizer’s Prevenar 20 to help protect infants and children against pneumococcal disease
13 March 2024 - Prevenar 20 (20 valent pneumococcal conjugate vaccine) offers the broadest serotype coverage of any paediatric pneumococcal ...
Posted by Michael Wonder on 26 Feb 2024
Voydeya recommended for approval in the EU by CHMP as add-on treatment to ravulizumab or eculizumab for adults with PNH who have residual haemolytic anaemia
26 February 2024 - Recommendation of first in class, oral, factor D inhibitor based on ALPHA Phase 3 trial results. ...
Posted by Michael Wonder on 26 Feb 2024
CSL Vifor and Travere Therapeutics announce sparsentan receives positive CHMP opinion for the treatment of IgA nephropathy
23 February 2024 - Positive CHMP opinion is based on pivotal Phase 3 PROTECT study results. ...
Posted by Michael Wonder on 26 Feb 2024
Highlights from the 19-22 February 2024 CHMP meeting
23 February 2024 - The EMA’s human medicines committee (CHMP) recommended 10 medicines for approval at its February 2024 meeting. ...
Posted by Michael Wonder on 24 Feb 2024
Vertex receives CHMP positive opinion for Kalydeco for the treatment of infants with cystic fibrosis ages 1 month and older
23 February 2024 - If approved, Kalydeco will be the first and only medicine approved in Europe to treat the underlying ...
Posted by Michael Wonder on 24 Feb 2024
Janssen receives positive CHMP opinion for Carvykti (ciltacabtagene autoleucel) for treatment in earlier lines of relapsed and refractory multiple myeloma
23 February 2024 - Results from the Phase 3 CARTITUDE-4 study, which supported the CHMP recommendation, showed that cilta-cel has the ...
Posted by Michael Wonder on 24 Feb 2024
First oral treatment against residual haemolytic anaemia in patients with paroxysmal nocturnal haemoglobinuria
23 February 2024 - The EMA has recommended granting a marketing authorisation in the European Union for Voydeya, the first ...
Posted by Michael Wonder on 24 Feb 2024
New treatment for rare motor neurone disease recommended for approval
23 February 2024 - The EMA has recommended granting a marketing authorisation in the European Union for a new therapy ...
Posted by Michael Wonder on 24 Feb 2024
Bristol Myers Squibb receives positive CHMP opinion for Reblozyl (luspatercept) for treatment of adults with transfusion-dependent anaemia due to low- to intermediate-risk myelodysplastic syndromes
23 February 2024 - In the pivotal Phase 3 COMMANDS study, Reblozyl nearly doubled the percentage of patients achieving primary ...
Posted by Michael Wonder on 24 Feb 2024
Merck receives positive EU CHMP opinion for Keytruda (pembrolizumab) in combination with chemotherapy as neo-adjuvant treatment, then continued as monotherapy as adjuvant treatment, for the treatment of resectable NSCLC at high risk of recurrence
23 February 2024 - Opinion granted based on positive overall survival and event-free survival results from the Phase 3 KEYNOTE-671 trial. ...
Posted by Michael Wonder on 20 Feb 2024
European Commission approves Pfizer’s Velsipity for patients with moderately to severely active ulcerative colitis
19 February 2024 - Velsipity is the first and only oral advanced ulcerative colitis therapy approved for use in patients 16 ...