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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

- PMLiVE

EC approves BMS cell therapy for multiple myeloma

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

- PMLiVE

AstraZeneca clears latest hurdle for Alexion acquisition after EU clearance

AZ first announced the proposed acquisition of Alexion in December 2020

- PMLiVE

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

- PMLiVE

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

- PMLiVE

Court rules on AZ and EU’s COVID-19 vaccine dispute

The Court in Brussels has ordered AZ to deliver a total of 80.2 million doses to the EU by 27 September 2021

- PMLiVE

AZ’s Tagrisso approved for EGFR-positive NSCLC in the EU

European Commission approved Tagrisso in this setting based on positive results from the ADAURA phase 3 study

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EU takes legal steps against AZ over delayed COVID-19 vaccine deliveries

Lawyers for the European Commission have asked the court to fine AZ €10m per infraction

Roche Basel Switzerland

EC approves Venclyxto-based combinations for newly diagnosed AML

The treatment is approved for newly diagnosed acute myeloid leukaemia patients who can’t receive intensive chemotherapy

- PMLiVE

EU asks AZ to deliver 120 million COVID-19 vaccines by the end of June

The EU has launched a new lawsuit against the drugmaker which could result in financial sanctions

- PMLiVE

FDA removes clinical hold on uniQure’s haemophilia gene therapy

Clinical hold placed following a case of hepatocellular carcinoma in a patient in the trial

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