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Clinical reports

Trust and transparency in Pharma & healthcare: impact of the COVID-19 pandemic

While it is obvious that trust in life science and healthcare companies is suboptimal, exactly how to improve the public’s trust is unclear...

Impetus Digital

- PMLiVE

AstraZeneca’s Tezspire recommended for approval in the EU by CHMP

The recommendation is for the treatment of severe asthma as an add-on therapy for patients 12 years and above

- PMLiVE

European Commission approves potential new treatment for Pompe disease

Nexviadyme is the first and only newly approved medicine for Pompe disease in Europe in over 15 years

- PMLiVE

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

- PMLiVE

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

- PMLiVE

Roche’s Polivy receives EC approval for lymphoma therapy

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

- PMLiVE

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

- PMLiVE

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

- PMLiVE

Janssen submits marketing authorisation to EMA for teclistamab

The drug has been developed to treat patients with relapsed or refractory multiple myeloma, an incurable blood cancer

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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

- PMLiVE

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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