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RSS FeedPosted by Michael Wonder on 15 Feb 2024
Launch of new HMA-EMA catalogues of real world data sources and studies
15 February 2024 - The EMA and the Heads of Medicines Agencies have launched two public electronic catalogues: one for ...
Posted by Michael Wonder on 14 Feb 2024
Galderma announces regulatory filing acceptance for nemolizumab in prurigo nodularis and atopic dermatitis in the US and EU
14 February 2024 - Nemolizumab was granted US FDA priority review for prurigo nodularis. ...
Posted by Michael Wonder on 14 Feb 2024
Celltrion seeks European approval for Actemra biosimilar
13 February 2024 - Celltrion said it has completed its application for marketing authorisation to the EMA for CT-P47, a ...
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 10 Feb 2024
Janssen submits type II extension of indication application to the EMA seeking approval of Rybrevant (amivantamab), in combination with lazertinib, for first-line treatment of patients with EGFR mutated non-small-cell lung cancer
8 February 2024 - The submission is supported by data from the Phase 3 MARIPOSA study, showing statistically significant and clinically ...
Posted by Michael Wonder on 06 Feb 2024
Ultragenyx receives PRIME designation from EMA for GTX-102 for the treatment of Angelman syndrome
5 February 2024 - GTX-102 is the first Angelman syndrome therapeutic candidate to receive PRIME designation. ...
Posted by Michael Wonder on 03 Feb 2024
Tisotumab vedotin marketing authorisation application validated by EMA for treatment of recurrent or metastatic cervical cancer
2 February 2024 - Genmab and Pfizer today announced that the EMA has validated for review the marketing authorisation application ...
Posted by Michael Wonder on 02 Feb 2024
Linvoseltamab receives EMA filing acceptance for treatment of relapsed/refractory multiple myeloma
2 February 2024 - Regeneron Pharmaceuticals today announced that the EMA has accepted for review the marketing authorisation application for linvoseltamab ...
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 30 Jan 2024
GSK’s RSV vaccine, Arexvy, accepted for regulatory review by the EMA for the prevention of RSV disease in adults aged 50-59 at increased risk
29 January 2024 - Application supported by positive results of a Phase 3 trial showing immune response and acceptable tolerability ...
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 26 Jan 2024
CHMP issues negative opinion for renewal of conditional marketing authorisation for Translarna (ataluren) following re-examination procedure
25 January 2024 - PTC Therapeutics announced today that the CHMP of the EMA issued a negative opinion following the re-examination ...