Oxford BioMedica notes the CTL019 MAA submission to the EMA for children, young adults with r/r B-cell ALL and adult patients with r/r DLBCL
Oxford, UK – 06 November 2017: Oxford BioMedica plc (“Oxford BioMedica” or “the Group”) (LSE:OXB), a leading gene and cell therapy group, today notes an announcement by Novartis confirming submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for CTL019 (tisagenlecleucel) for two indications. The application is for the treatment of children… Read More
Oxford BioMedica notes the sBLA submission to FDA for Kymriah™ in adult patients with r/r DLBCL
Oxford, UK – 31 October 2017: Oxford BioMedica plc (“Oxford BioMedica” or “the Group”) (LSE:OXB), a leading gene and cell therapy group, today notes an announcement by Novartis confirming submission of a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) for KymriahTM (tisagenlecleucel) suspension for… Read More
Oxford BioMedica to Present at Rodman & Renshaw Annual Global Investment Conference, New York
Oxford, UK – 5 September 2017: Oxford BioMedica plc (“Oxford BioMedica” or “the Group”) (LSE:OXB), a leading gene and cell therapy group, today announces that John Dawson, Chief Executive Officer, will be presenting at the Rodman & Renshaw Annual Global Investment Conference in New York on… Read More
CTL019 receives FDA approval for paediatric, young adult r/r B-cell ALL
London, UK – 30 August 2017: Oxford BioMedica plc (“Oxford BioMedica” or “the Group”) (LSE:OXB), a leading gene and cell therapy group, today notes that the US Food and Drug Administration (FDA) has approved Novartis’ CAR-T cell therapy CTL019 (tisagenlecleucel, brand name KymriahTM) for the treatment of relapsed and refractory… Read More
Oxford BioMedica announces a £2 million two-year collaboration co-funded by Innovate UK
The agreement is to explore a next generation gene and cell therapy manufacturing… Read More
Oxford BioMedica Announces MHRA Licence For Commercial Supply
London, UK – 07 August 2017: Oxford BioMedica plc (“Oxford BioMedica” or “the Group”) (LSE:OXB), a leading gene and cell therapy group, today announces that it has been granted a Manufacturer/Importer License (MIA), from the UK Medicines and Healthcare products Regulatory Agency (“MHRA”), to manufacture and distribute lentiviral vector material… Read More
FDA Advisory Committee Unanimously Recommends CTL019 (tisagenlecleucel) for Approval
London, UK – 13 July 2017: Oxford BioMedica plc (“Oxford BioMedica” or “the Group”) (LSE:OXB), a leading gene and cell therapy group, today notes that the US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee voted unanimously 10 to 0 in favour of approval of Novartis investigational therapy CTL019… Read More
Oxford BioMedica Announces a Major Supply Agreement
Oxford, UK – 6 July 2017: Oxford BioMedica plc (LSE:OXB) (“Oxford BioMedica” or “the Group”), a leading gene and cell therapy group, today announces that it has signed an agreement with Novartis for the commercial and clinical supply of lentiviral vectors used to generate CTL019 (tisagenlecleucel) and other undisclosed Chimeric… Read More
Oxford BioMedica Announces Refinancing of Debt Facility
London, UK – 30 June 2017: Oxford BioMedica plc (“Oxford BioMedica” or “the Group”) (LSE:OXB), a leading gene and cell therapy group, is pleased to announce it has today completed a new $55 million debt facility with Oaktree Capital Management – Strategic Credit Strategy (“Oaktree”). The facility has been used… Read More