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Europe

The latest European Pharmaceutical industry news

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EMA accepts two applications for datopotamab deruxtecan for oncology treatments
EMA accepts two applications for datopotamab deruxtecan for oncology treatments

AstraZeneca has announced that the European Medicines Agency (EMA) has validated two marketing authorisation applications (MAAs) for AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan (dato-dxd) in the treatment of two cancers.

7 April 2024Europe
Novo Nordisk’s Awiqli recommended by CHMP for diabetes treatment
Novo Nordisk’s Awiqli recommended by CHMP for diabetes treatment

Novo Nordisk has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorisation for Awiqli (once-daily basal insulin icodec) for the treatment of diabetes in adult patients.

7 April 2024Europe
European Commission approves Pfizer’s Velsipity for ulcerative colitis treatment
European Commission approves Pfizer’s Velsipity for ulcerative colitis treatment

Pfizer has announced that the EC has granted marketing authorisation for Velsipity (etrasimod) in the EU.

4 March 2024Europe
Vertex’s Casgevy for sickle cell disease treatment approved by European Commission
Vertex’s Casgevy for sickle cell disease treatment approved by European Commission

Vertex Pharmaceuticals has announced that the European Commission (EC) has granted conditional marketing authorisation to Casgevy (exagamglogene autotemcel), a crispr/cas9 gene-edited therapy.

4 March 2024Europe
CHMP shares positive opinion for GSK’s momelotinib for myelofibrosis treatment
CHMP shares positive opinion for GSK’s momelotinib for myelofibrosis treatment

GSK has announced that the CHMP of the EMA has given a positive recommendation to the company’s momelotinib for patients with myelofibrosis.

24 November 2023Europe
EC approves Daiichi Sankyo’s Vanflyta for acute myeloid leukaemia treatment
EC approves Daiichi Sankyo’s Vanflyta for acute myeloid leukaemia treatment

Daiichi Sankyo has announced that Vanflyta (quizartinib) has been approved in the EU for combination use with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy for adult patients with newly diagnosed acute myeloid leukaemia that is flt3-itd positive.

24 November 2023Europe
Roche’s Evrysdi approved by EC for babies under two months with spinal muscular atrophy
Roche’s Evrysdi approved by EC for babies under two months with spinal muscular atrophy

Roche has announced that the EC has approved the extension of Evrysdi’s marketing authorisation in the EU to include infants under two months with a clinical diagnosis of spinal muscular atrophy (SMA).

5 October 2023Europe
CHMP grants positive opinion to ViiV Healthcare’s cabotegravir for HIV prevention
CHMP grants positive opinion to ViiV Healthcare’s cabotegravir for HIV prevention

GSK has announced that ViiV healthcare has received a positive opinion from the EMA's CHMP, recommending marketing authorisation for cabotegravir long-acting (LA) injectable and tablets for HIV prevention.

24 August 2023Europe
European Parliament shares goal to tackle antimicrobial resistance
European Parliament shares goal to tackle antimicrobial resistance

The European Parliament has shared its recommendations for a ‘coordinated EU response to health threats posed by antimicrobial resistance,’ according to its press release.

2 July 2023Europe
European Commission delays release of major changes to pharma legislation
European Commission delays release of major changes to pharma legislation

The European Commission (EC) has again delayed the release of its new proposal for changes to Europe’s pharma legislation. The decision was previously expected on 29 March 2023, but has been announced to be “slightly later”.

30 April 2023Europe
AstraZeneca’s NMOSD treatment recommended marketing
AstraZeneca’s NMOSD treatment recommended marketing

Pharma giant AstraZeneca has been given a recommendation by the EU's Committee for Medicinal Products (CHMP) for marketing authorisation for ultomiris (ravulizumab), a treatment for adult patients with neuromyelitis optica spectrum disorder (NMSOD) who are anti-aquaporin-4 (AQP4) antibody positive (ab+).

30 April 2023Europe
AbbVie gains positive CHMP opinion for upadacitinib for the treatment of Crohn’s disease
AbbVie gains positive CHMP opinion for upadacitinib for the treatment of Crohn’s disease

AbbVie has announced that it has received positive feedback from the EMA's Committee for Medicinal Products for Human Use (CHMP) recommending the approval of upadacitinib (rinvoq) for the treatment of adult patients with moderate to severe crohn’s disease who have had an inadequate response, lost response or were intolerant to conventional therapies or biologic agents.

2 April 2023Europe