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- PMLiVE

Pierre Fabre

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EORTC and Pierre Fabre launch phase 3 trial for melanoma

Over 300,000 new cases of melanoma are diagnosed globally each year

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Roche’s Polivy receives EC approval for lymphoma therapy

The combination therapy is for patients with previously untreated diffuse large B-cell lymphoma

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EC approves Novartis’ Kymriah for advanced blood cancer

Kymriah is the first CAR-T cell therapy of its kind approved in the EU for follicular lymphoma

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Sanofi’s asthma treatment approved by European Commission

Dupixent is suitable for 6- to 11-year-old children who have severe asthma and type 2 inflammation

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Global Blood Therapeutics’ treatment for patients with sickle cell disease approved in Europe

The once-daily oral drug is the first medicine approved in Europe to treat the condition in adults and paediatric patients 12 years and older

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EMA proposes EU clinical trial reforms

The ACT EU paper provides a list of regulatory network objectives, priorities and governance strategies for 2022-2023

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Amgen’s Lumykras receives conditional marketing authorisation from EC

The drug is the first targeted therapy for patients diagnosed with advanced NSCLC with the KRAS G12C mutation

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EC approves BMS cell therapy for multiple myeloma

The approval of Abecma is based on “rapid, deep and durable” trial responses

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AstraZeneca clears latest hurdle for Alexion acquisition after EU clearance

AZ first announced the proposed acquisition of Alexion in December 2020

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EU identifies first five ‘promising’ COVID-19 drugs as part of therapeutics strategy

The five therapeutic candidates include a repurposed arthritis med and monoclonal antibodies

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BMS’s oral AML therapy Onureg receives EU approval

Onureg is the oral version of Vidaza, two of the drugs BMS gained as part of its acquisition of Celgene in 2019

Sanofi reception

Sanofi’s oral therapy Aubagio approved in the EU for paediatric MS patients

EC approval comes a few weeks after the FDA rejected Aubagio in the same patient population

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