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CRISPR Therapeutics

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EU governments pressure manufacturers to renegotiate contracts for COVID-19 vaccines

EU officials have warned that millions of vaccine doses could be wasted due to over-supply

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EC approves Roche’s Tecentriq for early-stage lung cancer

Tecentriq has now become the first cancer immunotherapy approved in Europe for the treatment of certain types of early-stage NSCLC

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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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NICE recommends Novartis’ Adakveo for sickle cell disease

The treatment for sickle cell disease is the first in more than 20 years

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Vertex expands further into cell and genetic therapies with a deal worth up to $1.2bn

A new deal will see Vertex harness Arbor Biotechnologies gene-editing technology to enhance its discovery efforts

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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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bluebird bio lodges counterclaim against Spark Therapeutics

Spark previously accused bluebird of misusing trademarks relating to the word ‘spark’ in marketing/educational materials

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