• Regulatory

Press Release: Over £100m cash boost to manufacture millions of doses of COVID-19 vaccine

- New state-of-the-art centre to scale up COVID-19 vaccine and gene therapy manufacturing gets £100m investment - Additional £4.7m for new training facilities and an online learning platform to boost vaccine as well as cell and gene therapy skills - New centre and skills vital for the UK’s ability respond to diseases like coronavirus, and potential future pandemics

CGT Catapult Annual Review 2020 highlights impact on growth and productivity in the UK cell and gene therapy industry

The 2020 annual report released today presents Cell and Gene Therapy Catapult's achievements, collaborations and initiatives from the past year and their impact in enhancing growth, productivity and supporting the development and commercialisation of cell and gene therapies.

Life Sciences Recovery Roadmap

The COVID-19 crisis has powerfully demonstrated the strategic importance of the life science sector to the UK’s health, security, and to the economy.

Fieldfisher Life Sciences sector group mobilises to offer pro bono legal advice for COVID-19

Fieldfisher are delighted to announce that their pan-European Life Sciences sector group have mobilised to show support for life science companies contributing efforts towards global pandemic COVID-19.

Impact of the ATTC Network after 18 months of operation

Just 18 months ago, the Advanced Therapy Treatment Centre (ATTC) network was set up through funding from the UK Research and Innovation Industrial Strategy Challenge Fund.

ERS Genomics announces agreement with New England Biolabs to commercialize CRISPR gene editing tools and reagents

ERS Genomics Limited, which was formed to provide broad access to the foundational CRISPR/Cas9 intellectual property (IP) co-owned by Dr. Emmanuelle Charpentier, today announced it has signed an agreement with New England Biolabs (NEB®), a global leader in the discovery and production of enzymes for molecular biology applications, granting NEB rights to sell CRISPR/Cas9 tools and reagents.

CGT Catapult hosts second annual workshop to address digital challenges in adoption of advanced therapies by the NHS

Experts addressed different possible models for optimising data collection to support the adoption of cell and gene therapies in the UK. Barriers to digital integration, post-launch data collection and outcomes-based reimbursement were the primary focus of the day.

Prokarium announces MHRA acceptance to run Phase I trial of lead vaccine against enteric fever

Prokarium, a private biotechnology company developing vaccines against infectious diseases and immunotherapy for solid tumors, has received Clinical Trial Authorization (CTA) acceptance from the UK Medicines and Healthcare products Regulatory Agency (MHRA) to run a first-in-human Phase I trial with Entervax™, a bivalent vaccine against enteric fever.

BIA blog | CJEU decision denies SPCs for new formulations

The latest decision concerning Supplementary Protection Certificates (SPCs) was handed down by the CJEU in the Abraxis Bioscience case (C-443/17) on 21 March. The BIA’s IP Advisory Committee (IPAC) provided informal views on behalf of the sector to the UK Intellectual Protection Office (IPO) regarding this case, to inform the UK Government’s representations to the CJEU. Andrew Hutchinson of Simmons & Simmons and a member of IPAC has provided the following analysis for BIA members.

The Top 5 things pharmaceutical firms can do to prepare for no-deal

Delivering the deal negotiated with the EU is the Government’s priority. However, preparing for any outcome is recommended and many UK-based pharmaceutical firms would be affected by a ‘No Deal’ Exit from the EU. Here are the top five tips on preparation for no-deal.