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Legend Biotech

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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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Janssen and Legend Biotech’s Carvykti receives FDA approval for patients with relapsed or refractory multiple myeloma

In the study, 98% of patients with relapsed or refractory multiple myeloma responded to a one-off treatment of the drug

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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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Janssen’s Tremfya receives positive results for active psoriatic arthritis

The drug demonstrated positive joint efficacy and ranked highest for skin clearance when compared to existing therapies

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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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J&J’s COVID-19 booster shows 85% effectiveness in preventing hospitalisation for COVID-19 in study

The Sisonke study was done in South Africa while Omicron was the dominant variant

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US prefers mRNA COVID-19 vaccines over J&J

Citing concerns over blood clots, Americans are now advised that should get the Pfizer-BioNTech or Moderna vaccines in preference to Johnson and Johnson vaccine

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US COVID-19 booster programme expanded

The FDA and CDC have given the green light to an expansion of the US COVID-19 booster programme to include another shot of the Moderna and J&J vaccines as well...

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