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RSS FeedPosted by Michael Wonder on 19 Sep 2022
European Commission approves Roche’s Vabysmo, the first bispecific antibody for the eye, for two leading causes of vision loss
19 September 2022 - Phase 3 data that showed people with neovascular or ‘wet’ age-related macular degeneration and diabetic macular oedema treated with ...
Posted by Michael Wonder on 19 Sep 2022
BeiGene receives positive CHMP opinion for Brukinsa (zanubrutinib) for the treatment of adults with marginal zone lymphoma
19 September 2022 - If approved, Brukinsa will be the first and only approved Bruton’s tyrosine kinase inhibitor for marginal zone ...
Posted by Michael Wonder on 19 Sep 2022
Bristol Myers Squibb receives European Commission approval for LAG-3 blocking antibody combination, Opdualag (nivolumab and relatlimab), for the treatment of unresectable or metastatic melanoma with tumour cell PD-L1 expression < 1%
16 September 2022 - In RELATIVITY-047, Opdualag more than doubled median progression-free survival compared to nivolumab monotherapy. ...
Posted by Michael Wonder on 19 Sep 2022
AbbVie secures positive CHMP opinion for risankizumab (Skyrizi) for the treatment of adults with moderate to severe Crohn's disease
19 September 2022 - CHMP positive opinion is based on results from three Phase 3 studies: two for induction and one ...
Posted by Michael Wonder on 18 Sep 2022
Agios receives positive CHMP opinion for Pyrukynd (mitapivat) for the treatment of pyruvate kinase deficiency in adult patients
16 September 2022 - Agios expects a decision on the marketing authorisation application by the European Commission within 67 days of ...
Posted by Michael Wonder on 17 Sep 2022
EMA recommends standard marketing authorisations for Comirnaty and Spikevax COVID-19 vaccines
16 September 2022 - The EMA’s CHMP has recommended converting the conditional marketing authorisations of the COVID-19 vaccines Comirnaty (BioNTech/Pfizer’s ...
Posted by Michael Wonder on 17 Sep 2022
Highlights from the 12-15 September 2022 CHMP meeting
16 September 2022 - 12 new medicines recommended for approval. ...
Posted by Michael Wonder on 17 Sep 2022
ADC Therapeutics and Sobi announce Zylonta (loncastuximab tesirine) receives positive CHMP opinion in Europe for the treatment of relapsed or refractory diffuse large B-cell lymphoma
16 September 2022 - Approval decision expected in 4Q 2022. ...
Posted by Michael Wonder on 17 Sep 2022
Merck receives positive CHMP opinion for Vaxneuvance (pneumococcal 15 valent conjugate vaccine) in infants and children
16 February 2022 - Merck announced today that the EMA’s CHMP has recommended the approval of Vaxneuvance (pneumococcal 15 valent conjugate ...
Posted by Michael Wonder on 17 Sep 2022
Leo Pharma receives positive CHMP opinion of Adtralza (tralokinumab) for the treatment of adolescents with moderate to severe atopic dermatitis
16 September 2022 - Recommendation supported by data from the Phase 3 ECZTRA 6 trial. ...
Posted by Michael Wonder on 17 Sep 2022
CHMP adopts positive opinion to extend indication of Veklury (remdesivir) for the treatment of paediatric patients with COVID-19
16 September 2022 - If granted by the European Commission, Veklury will become the first and only authorised anti-viral treatment for ...
Posted by Michael Wonder on 17 Sep 2022
Kite’s CAR T-cell therapy Yescarta first in Europe to receive positive CHMP opinion for use in second-line diffuse large B-cell lymphoma and high-grade B-cell lymphoma
16 September 2022 - Positive opinion based on landmark ZUMA-7 study in which 41% of patients demonstrated event-free survival at ...
Posted by Michael Wonder on 16 Sep 2022
Evusheld long-acting antibody combination recommended for approval in the EU for the treatment of COVID-19
16 September 2022 - Recommendation based on TACKLE Phase 3 treatment data showing reduced risk of severe COVID-19 or death. ...
Posted by Michael Wonder on 16 Sep 2022
CHMP recommends approval of Beyfortus (nirsevimab) for prevention of RSV disease in infants
16 September 2022 - Recommendation is based on the Beyfortus clinical trial program which demonstrated protection against medically attended lower respiratory ...
Posted by Michael Wonder on 13 Sep 2022
Novavax Nuvaxovid COVID-19 vaccine granted expanded conditional marketing authorisation in the European Union for use as a booster for adults aged 18 and older
12 September 2022 - Nuvaxovid is now authorised in the EU for use in adults aged 18 and older as ...