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Imfinzi approved in EU to treat extensive-stage small cell lung cancer
Imfinzi (durvalumab) has been approved by the European Commission as a first-line treatment for extensive-stage small cell lung cancer, with chemotherapy.
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Pfizer and BioNTech may supply EU with 200 million doses of COVID-19 vaccine
The companies and European Commission will soon enter contract negotiations for the supply of their investigational COVID-19 vaccine candidate BNT162b2.
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Blenrep granted CMA for relapsed or refractory multiple myeloma
The European Commission granted the conditional marketing authorisation (CMA) based on data from a trial in which Blenrep achieved an overall response rate of 32 percent.
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Vertex’s Kaftrio approved for use in Europe and made accessible on the NHS
The European Commission and European Medicines Agency have approved the triple combination Kaftrio for use in certain cystic fibrosis patients, triggering the drug to be accessible on the UK’s National Health Service.
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AstraZeneca to supply Europe with up to 400 million doses of COVID-19 vaccine
An agreement between AstraZeneca and the European Commission means the company will supply up to 400 million doses of its AZD1222 COVID-19 vaccine.
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European Commission approves Novartis’ Xolair® (omalizumab)
Novartis' Xolair (omalizumab) has been approved by the European Commission as an add-on therapy with intranasal corticosteroids to treat severe chronic rhinosinusitis with nasal polyps.
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Sanofi and GSK to supply UK with 60 million doses of COVID-19 vaccine
Sanofi and GSK have reached an agreement with the UK government to supply up to 60 million doses of their COVID-19 vaccine.
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EC approves subcutaneous formulation of Remsima®
The European Commission has granted marketing authorisation to Celltrion's Remsima (infliximab, CT-P13) subcutaneous formulation.
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CureVac recieves €75 million loan for vaccine development and manufacturing expansion
The European Investment Bank (EIB) will provide three €25 million instalments to support CureVac’s vaccine development and expansion to mRNA production facilities.
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EMA recommends Idefirix (imlinfidase) is granted marketing authorisation
The European Medicines Agency (EMA) recommended Idefirix is granted conditional marketing authorisation for highly sensitised patients awaiting kidney transplant.
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CHMP recommends cystic fibrosis treatment Kaftrio is granted marketing authorisation
The European Medicines Agency's human medicines committee (CHMP) said the treatment would offer a therapeutic option for certain cystic fibrosis phenotypes that are currently untreatable.
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Further billions pledged to ensure equitable access to COVID-19 treatments
The European Investment Bank (EIB), in partnership with the European Commission (EC), have pledged an additional €4.9 billion for use in the global coronavirus response funds.
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Life sciences M&A activity during the global pandemic
COVID-19 has severely disrupted the lives of many people around the world. In this article, corporate partner Theo Godfrey and competition partner Russell Hoare from the life sciences team at law firm CMS Cameron McKenna Nabarro Olswang LLP consider some issues related to COVID-19 that have impacted life sciences merger…
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EMA gives positive opinion to investigational Ebola vaccine regimen
Developed by Janssen, the two-dose regimen has already been given to 60,000 patients and now has the positive opinion of the Committee for Medicinal Products for Human Use (CHMP).
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How to improve vaccine procurement strategies to optimise coverage in Europe
Tim Wilsdon and Ryan Lawlor from Charles River Associates explain why price-based procurement strategies can limit the long-term effectiveness and sustainability of vaccine programmes.
