Boyds appoints Consultant Pharmaceutical Physician
Boyds is delighted to welcome Christine Smith as a Consultant Pharmaceutical Physician to support the clinical activities of the company and in particular supporting the work being undertaken in cell and gene therapy development. Christine qualified with a Bachelor of Medicine and Bachelor of Surgery in 1999 from the University of the Free State in […]
Clarification on the assessment of ATMPs
Boyds has welcomed the very timely final Regulation (EU) 2018/781 from the European Commission which describes the criteria to be used in the assessment of similarity for orphan designated ATMPs. Previous to this, the only definitions and examples available were suited to NCEs and biologics. This is timely because increasingly, owing to a significant rise […]
Boyds recognised with prestigious Queen’s Award for Enterprise
Boyds has today been recognised with one of the UK’s most prestigious business awards – The Queen’s Award for Enterprise, International Trade for Outstanding Short Term Growth in overseas sales for the last three years. The Award has been made in recognition for Boyds’ work, particularly in supporting the development of cell and gene therapies, […]
AMO Pharma announces results of Phase 2 proof-of-concept study of AMO-02 in Congenital and Childhood Onset Myotonic Dystrophy Type 1
AMO Pharma Announces Results of Phase 2 Proof-of-Concept Study of AMO-02 in Congenital and Childhood Onset Myotonic Dystrophy Type 1 – Patients showed significant improvements in cognitive function, levels of fatigue and ability to perform daily tasks – Treatment shown to be safe and well tolerated AMO Pharma Limited (“AMO Pharma”), a privately held biopharmaceutical […]
Health & Social Care Select Committee’s report on medicines, devices and substances of human origin has now been published
Back in December, Professor Alan Boyd was invited to appear before the Health & Social Care Select Committee in his capacity as President of the Faculty of Pharmaceutical Medicine. The report that followed was published this week and has been welcomed by the Academy of Medical Royal Colleges. Notably the report urges Government to seek […]
Evaluation of advanced therapy medicines
The European Medicines Agency (EMA) has updated its procedural advice on the evaluation of advanced therapy medicinal products (ATMPs). The update aims to streamline some procedures, strengthen collaboration between EMA’s scientific committees and address specific needs of ATMP developers in the evaluation procedure for initial marketing authorisations, to help developers navigate the regulatory process in […]
Boyds acquires new Cambridge office to support rapid growth
Boyds is delighted to announce the opening of its new Cambridge office, which has involved an investment in excess of £0.5m in the purchase and complete refurbishment of a 1700 sq ft building located at South Cambridge Business Park in Sawston. Boyds was previously located in Cottenham, a village on the outskirts of the city, […]
European Medicines Agency to move to Amsterdam
Today’s ballot in Brussels, which involved representatives of every EU country (excluding the UK), has resulted in Amsterdam being selected as the new home for the European Medicines Agency (EMA). Along with the prestige of hosting the EMA, Amsterdam will receive a boost for their pharmaceutical industry and increased access to expert researchers. A total […]
Regulatory Rapporteur
Dr Julie Warner, Director of Regulatory Affairs at Boyds, is also the Associate Editor of TOPRA’s Regulatory Rapporteur journal. In the latest issue, Dr Warner, along with co-author Clare Matti, discuss the latest developments in the regulatory field, with a focus on North America, African medicines regulatory harmonisation, and best practices in regulatory information management. […]
FDA approval brings first gene therapy to the United States
The FDA issued a historic action, making the first gene therapy available in the United States, ushering in a new approach to the treatment of cancer and other serious and life-threatening diseases. The FDA approved Kymriah (tisagenlecleucel) for certain pediatric and young adult patients with a form of acute lymphoblastic leukemia (ALL). Kymriah, a cell-based […]
