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RSS FeedPosted 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
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
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 21 Feb 2024
FDA and EMA accept vorasidenib regulatory submissions for the treatment of IDH mutant diffuse glioma
20 February 2024 - In clinical studies, vorasidenib has demonstrated strong blood-brain barrier penetrance alongside clinically meaningful and statistically significant ...
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 19 Feb 2024
EMA publishes agenda for 19-22 February 2024 CHMP meeting
19 February 2024 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted 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
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 ...