Blog
RSS FeedPosted by Michael Wonder on 22 Oct 2024
CHMP recommends the approval of Dong-A ST’s Imuldosa, a biosimilar to Stelara
21 October 2024 - Dong-A ST announced on 18 October 2024 that its biosimilar Imuldosa (ustekinumab, development code DMB-3115), referencing ...
Posted by Michael Wonder on 22 Oct 2024
Highlights from the 14-17 October 2024 CHMP meeting
18 October 2024 - The CHMP recommended granting a marketing authorisation for Alhemo (concizumab), a medicine for routine prophylaxis of ...
Posted by Michael Wonder on 21 Oct 2024
Wainzua (eplontersen) recommended for approval in the EU by CHMP for the treatment of adult patients with polyneuropathy associated with hereditary transthyretin-mediated amyloidosis
21 October 2024 - Recommendation based on NEURO-TTRansform Phase 3 results showing Wainzua demonstrated consistent and sustained benefit improving neuropathy ...
Posted by Michael Wonder on 18 Oct 2024
Alhemo recommended for European approval as first once daily subcutaneous prophylactic treatment for people living with haemophilia A or B with inhibitors
18 October 2024 - Novo Nordisk today announced that the EMA's CHMP has adopted a positive opinion, recommending approval of ...
Posted by Michael Wonder on 18 Oct 2024
Novartis receives positive CHMP opinion for Kisqali to help reduce risk of recurrence in people with HR+/HER2- early breast cancer
18 October 2024 - Recommendation is based on the Phase 3 NATALEE trial, where Kisqali added to endocrine therapy significantly reduced ...
Posted by Michael Wonder on 11 Oct 2024
Novavax's updated 2024-2025 Nuvaxovid COVID-19 vaccine receives authorisation in the EU
9 October 2024 - Novavax today announced that the European Commission granted marketing authorisation for Novavax's updated 2024-2025 Nuvaxovid COVID-19 vaccine ...
Posted by Michael Wonder on 25 Sep 2024
GSK’s Menveo meningococcal vaccine in new single-vial, fully liquid presentation receives positive European CHMP opinion
24 September 2024 - Marketing authorisation in EU expected by November 2024. ...
Posted by Michael Wonder on 24 Sep 2024
European Commission approves Leo Pharma’s Anzupgo (delgocitinib) cream for adults with moderate to severe chronic hand eczema
23 September 2024 - Anzupgo is the first topical treatment to be specifically indicated for adult patients living with moderate to ...
Posted by Michael Wonder on 24 Sep 2024
Ipsen’s Kayfanda (odevixibat) approved in European Union for cholestatic pruritus in Alagille Syndrome, a rare liver disease
23 September 2024 - E.U. marketing authorization for Kayfanda based on data from ASSERT the only Phase 3 trial completed in ...
Posted by Michael Wonder on 24 Sep 2024
Merck receives positive EU CHMP opinions for Keytruda (pembrolizumab) regimens as treatment for patients with two types of gynaecologic cancers
20 September 2024 - Positive opinion granted for Keytruda plus chemotherapy for the first-line treatment of adult patients with primary advanced ...
Posted by Michael Wonder on 23 Sep 2024
Fasenra recommended for approval in the EU by CHMP for the treatment of eosinophilic granulomatosis with polyangiitis
23 September 2024 - New indication supported by the MANDARA trial which showed nearly 60% of patients achieved remission and ...
Posted by Michael Wonder on 23 Sep 2024
Henlius and Intas receive positive CHMP opinion for Hetronifly in European markets as first-line treatment for adult patients with extensive-stage small cell lung cancer
21 September 2024 - Hetronifly (serplulimab) is expected to become the first anti-PD-1 monoclonal antibody available in Europe for first-line treatment ...
Posted by Michael Wonder on 22 Sep 2024
Wegovy recommended by the European regulatory authorities for label update to reflect reduced heart failure symptoms and improved physical function
19 September 2024 - Novo Nordisk today announced that the EMA's CHMP has adopted a positive opinion for an update of ...
Posted by Michael Wonder on 21 Sep 2024
Astellas receives approval from the European Commission for Vyloy (zolbetuximab) in combination with chemotherapy for advanced gastric and gastro-oesophageal junction cancer
20 September 2024 - Treatment with the claudin 18.2 targeted monoclonal antibody shown to significantly extend both progression-free survival and ...
Posted by Michael Wonder on 20 Sep 2024
Dupixent (dupilumab) recommended for EU approval by the CHMP to treat eosinophilic oesophagitis in children as young as 1 year old
20 September 2024 - Recommendation based on a Phase 3 trial showing a significantly greater proportion of children on Dupixent achieved ...