Europe

Europe

The latest European Pharmaceutical industry news

CHMP grants positive opinion to ViiV Healthcare’s cabotegravir for HIV preventionCHMP 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.

Aug 24, 2023 Europe
European Parliament shares goal to tackle antimicrobial resistanceEuropean 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.

Jul 2, 2023 Europe
European Commission delays release of major changes to pharma legislationEuropean 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”.

Apr 30, 2023 Europe
AstraZeneca’s NMOSD treatment recommended marketingAstraZeneca’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+).

Apr 30, 2023 Europe
AbbVie gains positive CHMP opinion for upadacitinib for the treatment of Crohn’s diseaseAbbVie 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.

Apr 2, 2023 Europe
CSL receives CMA from the European Commission for haemophilia B drugCSL receives CMA from the European Commission for haemophilia B drug
CSL receives CMA from the European Commission for haemophilia B drug

CSL, a biotech company, has announced that it has received conditional marketing authorisation (CMA) from the European Commission (EC) for its haemophilia b drug hemgenix.

Apr 2, 2023 Europe
Merck to appeal EU rejection of COVID-19 drugMerck to appeal EU rejection of COVID-19 drug
Merck to appeal EU rejection of COVID-19 drug

Life sciences giant Merck & Co has announced that it will appeal the EU's committee for Medicinal Products for Human Use’s (CHMP) decision to not recommend approval for its COVID-19 drug lagevrio.

Apr 2, 2023 Europe
Europe Plans Further Antibiotic Shortage CountermeasuresEurope Plans Further Antibiotic Shortage Countermeasures
Europe Plans Further Antibiotic Shortage Countermeasures

Following the increase in respiratory infections, the continuing cost of living crisis and the Russia-Ukraine conflict, Europe is planning countermeasures for further antibiotic shortages

Mar 6, 2023 Europe
AstraZeneca Moves Manufacturing To Ireland Due To Britain’s Tax RegimeAstraZeneca Moves Manufacturing To Ireland Due To Britain’s Tax Regime
AstraZeneca Moves Manufacturing To Ireland Due To Britain’s Tax Regime

AstraZeneca has announced plans to open a new facility in Ireland, previously planned for northwest England

Mar 6, 2023 Europe
Genoscience Pharma Received Orphan Drug Designation For Hepatocellular Carcinoma DrugGenoscience Pharma Received Orphan Drug Designation For Hepatocellular Carcinoma Drug
Genoscience Pharma Received Orphan Drug Designation For Hepatocellular Carcinoma Drug

Genoscience Pharma has received FDA ODD for its hepatocellular carcinoma drug

Mar 6, 2023 Europe
European Commission Approves Dupixent® As The First And Only Targeted Medicine For Prurigo NodularisEuropean Commission Approves Dupixent® As The First And Only Targeted Medicine For Prurigo Nodularis
European Commission Approves Dupixent® As The First And Only Targeted Medicine For Prurigo Nodularis

Regeneron Pharmaceuticals and Sanofi have announced that the European Commission (EC) has expanded the marketing authorisation for Dupixent® (dupilumab) in the European Union to treat adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy.

Feb 1, 2023 Europe
ServBlock Secures EU Funding For Pharma Manufacturing Data SpaceServBlock Secures EU Funding For Pharma Manufacturing Data Space
ServBlock Secures EU Funding For Pharma Manufacturing Data Space

ServBlock, an Irish start-up, and Irish Manufacturing Research (IMR), have been given EU funding to build a data exchange system for outsourced pharmaceutical manufacturing.

Feb 1, 2023 Europe