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Pfizer, BioNTech could supply EU with 300m doses of SARS-CoV-2 vaccine pharmatimes
September 24, 2020
Pfizer and BioNTech have concluded exploratory talks with the European Commission for a proposed supply of 200 million doses of their investigational BNT162 mRNA-based vaccine candidate against SARS-CoV-2 to EU nations ...
EU review extended for BioMarin's gene therapy Valrox pharmatimes
September 24, 2020
European regulators have requested more data to review the marketing application for BioMarin's haemophilia A gene therapy Valrox (valoctocogene roxaparvove).
GSK’s Zejula and AZ’s Lynparza leap toward broader EU approval pharmatimes
September 23, 2020
GlaxoSmithKline’s Zejula and AstraZeneca’s Lynparza have both moved towards EU approval in new indications after receiving positive opinions from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).
GenSight Biologics seeks EU approval for gene therapy pharmatimes
September 17, 2020
French biopharma company Gensight Biologics has submitted a marketing authorisation application for its lead gene therapy Lumevoq to the European Medicines Agency (EMA).
EU expands scope of Imbruvica to include untreated CLL patients pharmatimes
September 17, 2020
The European Commission (EC) has expanded the marketing authorisation for Janssen's Imbruvica (ibrutinib) to include treatment naïve patients with chronic lymphocytic leukaemia (CLL).
Imfinzi approved in EU to treat extensive-stage small cell lung cancer europeanpharmaceuticalreview
September 14, 2020
Imfinzi (durvalumab) has been approved by the European Commission as a first-line treatment for extensive-stage small cell lung cancer, with chemotherapy.
EU OKs paediatric use of Gilead's Epclusa pharmatimes
September 03, 2020
The European Commission (EC) has expanded marketing authorisation for Gilead's Epclusa (sofosbuvir/velpatasvir/sofosbuvir) to include the treatment of children with chronic hepatitis C infection (HCV).
EU approves AstraZeneca’s Imfinzi for treatment of extensive-stage small cell lung cancer expresspharma
September 02, 2020
Imfinzi, in combination with etoposide and either carboplatin or cisplatin, is also approved in the US, Japan and several other countries for the treatment of ES-SCLC.
GSK bags EU approval for Blenrep pharmatimes
August 27, 2020
Hot on the heels of US approval GlaxoSmithKline has now also bagged a nod in Europe for Blenrep (belantamab mafodotin-blmf) as a treatment for patients with relapsed for refractory multiple myeloma (MM).
EU nod for Vertex CF therapy Kaftrio pharmatimes
August 24, 2020
Vertex Pharmaceuticals' Kaftrio (ivacaftor/tezacaftor/elexacaftor) has been approved by the European Commission for use in combination with ivacaftor to treat people aged 12 years and older with certain forms of cystic fibrosis.

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