• Regulatory

New senior hire for the medical writing team at Boyds

Leading global drug development consultancy Boyds has made a new appointment to its medical writing team in response to rising demand for its services.

CEO Update - 15 May 2023

Today we launched the #BIGIMPACT campaign to encourage next-generation digital talent to start a career in the biotech industry. The campaign addresses an urgent need for data, machine learning and AI skills and shines a spotlight on new career pathways that are possible in biotech.

Redx's discovery of pirtobrutinib recognised with unveiling of commemorative plaque

Redx, the clinical-stage biotechnology company focused on discovering and developing novel, small molecule, targeted therapeutics for the treatment of cancer and fibrotic disease confirms that a commemorative plaque has been unveiled by Bruntwood SciTech at their Alderley Park campus, where Redx is headquartered, in recognition of the team's discovery of pirtobrutinib, the active pharmaceutical ingredient (API) in Eli Lilly's Jaypirca™.

CEO Update - 9 May 2023

It was heartening last week to see positive results from Lilly's trial of donanemab for Alzheimer’s disease. It is an important step and, although there is a long way to go before products like these become routine in clinical practice in the UK, it is great to see positive news. An experimental Alzheimer's drug slowed cognitive decline by 35% in a late-stage trial with 1,182 people, providing what experts say is the strongest evidence yet that removing sticky amyloid plaques from the brain benefits patients with the fatal disease. Read on for VPAS, local elections, FCA reforms and a new approach to importing into Great Britain.

Medannex’s first-in-class therapy awarded UK ‘Innovation Passport’ to accelerate time to market

Medannex Ltd (Edinburgh) today announced the award of an Innovation Passport from the UK’s Innovative Licensing and Access Pathway (ILAP) Steering Group, to accelerate the time to market for its first-in-class annexin-A1-targetting monoclonal antibody therapy, MDX-124.

Medannex’s First-in-class Therapy receives EMA Orphan Designation for the Treatment of Pancreatic Cancer

Medannex Ltd (Edinburgh) announced today that MDX-124, a monoclonal antibody against annexin-A1, has received Orphan Medicinal Product positive opinion from the European Medicines Agency (EMA) for the treatment of pancreatic cancer.

Further growth for regulatory affairs team at Boyds

Leading global drug development consultancy Boyds has appointed experienced regulatory professional Harriet Edwards in response to a sustained rise in demand for its specialist regulatory services and expertise.

Diagnostics industry helps MHRA shape IVDs roadmap as part of future UK regulation

The MHRA will build its new UK system of medtech regulation on seven regulatory pillars, one of which is an IVD roadmap, says diagnostics industry association BIVDA. The trade body gave an update on the focus groups, UKAB numbers and timings for three awaited statutory instruments.

CEO Update | 20 February 2023

I’m looking forward to seeing many of you at this year's BIA Committee Summit this Thursday – always a vibrant and engaging event with BIA member expertise overflowing the venue – which this year is Church House in Westminster. The idea of the day is for each of our expert Advisory Committees to hold their first meeting of the year in the same place at the same time – so they can come together in a plenary session to understand common themes and make connections.

CEO Update | 6 February 2023

Thank you for your ongoing support for our SME R&D tax relief campaign highlighting the negative impact of the relief rate changes announced in the Autumn Statement for biotech. Thanks to our combined efforts, the Chancellor has said he sees 'merit to the case for further support' for 'R&D intensive businesses'. This is great news, but the devil will be in the detail, so we need your help. Please complete our survey.