Blog
RSS FeedPosted 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 ...
Posted by Michael Wonder on 13 Feb 2024
European Commission approves first CRISPR/Cas9 gene-edited therapy, Casgevy (exagamglogene autotemcel), for the treatment of sickle cell disease and transfusion-dependent beta thalassaemia
13 February 2024 - Over 8,000 patients 12 years of age and older with severe sickle cell disease or transfusion-dependent ...
Posted by Michael Wonder on 13 Feb 2024
Biogen received European Commission approval for Skyclarys (omaveloxolone), the first therapy to treat Friedreich’s ataxia
12 February 2024 - Biogen announced the European Commission has authorised Skyclarys (omaveloxolone) for the treatment of Friedreich’s ataxia in ...
Posted by Michael Wonder on 30 Jan 2024
European Commission authorises GSK’s Omjjara (momelotinib)
29 January 2024 - Indicated in both newly diagnosed patients and those previously treated with existing standard of care. ...
Posted by Michael Wonder on 30 Jan 2024
Takeda’s Hyqvia approved by European Commission as maintenance therapy in patients with chronic inflammatory demyelinating polyneuropathy
30 January 2024 - At home or in office administration provides CIDP patients with a personalised treatment experience. ...
Posted by Michael Wonder on 27 Jan 2024
Highlights from the 22-25 January 2024 CHMP meeting
26 January 2024 - The EMA’s CHMP recommended three medicines for approval at its January 2024 meeting. ...
Posted by Michael Wonder on 26 Jan 2024
Bristol Myers Squibb receives positive CHMP opinion for CAR T-cell therapy Abecma (idecabtagene vicleucel) in earlier lines of therapy for triple class exposed relapsed and refractory multiple myeloma
26 January 2024 - Recommendation for approval based on Phase 3 KarMMa-3 study in which Abecma demonstrated superiority over standard regimens, ...
Posted by Michael Wonder on 17 Jan 2024
European Commission approves Roche’s Tecentriq SC, the EU's first PD-(L)1 cancer immunotherapy subcutaneous injection for multiple cancer types
16 January 2024 - Roche is working closely with national health systems in Europe to ensure patients can access Tecentriq ...
Posted by Michael Wonder on 12 Jan 2024
European Commission approves Krazati (adagrasib) as a targeted treatment option for patients with advanced non-small-cell lung cancer with a KRAS G12C mutation
10 January 2024 - Mirati Therapeutics today announced that the European Commission granted conditional marketing authorisation for Krazati (adagrasib) as ...
Posted by Michael Wonder on 11 Jan 2024
STADA and Alvotech secure approval for Uzpruvo, Europe’s first ustekinumab biosimilar to Stelara
10 January 2024 - Approval for the Uzpruvo biosimilar is based on comprehensive package comprising analytical, non-clinical and clinical similarity ...
Posted by Michael Wonder on 10 Jan 2024
European Commission approves Pfizer’s Talzenna in combination with Xtandi for adult patients with metastatic castration resistant prostate cancer
8 January 2024 - Talzenna is the first and only PARP inhibitor approved in combination with standard of care Xtandi ...