Cheryl Barton

Centogene NV and ROPAD consortium publish data from a landmark study identifying genetic variants that may respond to innovative cell and gene therapies.

The European Commission has developed a roadmap aimed at reversing the rising trend of cancer across the European Union.

Novel mitophagy inducers and gene therapies that restore cellular function and decelerate the ageing process.

Regulators, EMA and HMA, have published principles and recommendations on the use of LLMs, which are being increasingly used for daily tasks.

What impact will the AI Act have on pharma and digital medicine?

Germany’s Medical Research Act allows pharmaceutical companies to keep drug prices confidential.

Innovative solutions are making personalized cell and gene therapies accessible to all.

EMA is promoting the use of RWD in decision-making and has started a public consultation to review its draft recommendations.

Novel delivery technologies enhance brain penetration to target neurodegenerative diseases and glioblastomas.

The European pharma industry needs to be prepared for the new clinical data requirements.

Novel genetic engineering technologies are transforming the design and manufacture of bispecific antibodies, which are emerging as a promising new class of biologics.

The UK’s IRP increases flexibility and will help speed up product approvals and patient access to medicines.

Novel molecular glues are transforming targeted protein degradation.

The EHDS aims to increase access to health data, but how will it impact pharma?

What does the 2024 VPAS mean for pharma?

New radiotherapeutic agents are making headway in hard-to-treat cancers.

The new framework will position the UK as an attractive prospect for new medicine manufacturers.

Tumour-infiltrating lymphocyte (TIL) therapies offer a new route to target cancer.

What impact will EMA’s decision to phase out COVID-19 regulatory flexibilities have on the pharma industry?

What implications will EMA’s recent regulatory reform have on pharma?

Competition in the organ-on-a-chip market increases as NETRI enters the arena.

Stepwise paediatric investigation plans aim to boost the development of medicines for children.

TreeFrog Therapeutics is leaping ahead in cell therapies through resources such as new technologies and investor partnerships.

The European Human Medicines Directive and Regulation is due to be updated by the end of 2022, but what changes are on the cards?

A new unitary patent system is due to come into effect in Europe later on this year.

Pharma’s leveraging real-world evidence to drive product approval, reimbursement, and market access.

On 26 May 2022, the European Commission will roll-out the new in-vitro diagnostic regulation.

In January 2022, Europe started to implement EU-CTR, a new regulatory framework for clinical trials, but what does this mean for pharma clinical research?

Pharma’s interest in decentralized clinical trials (DCTs) increases as it helps to expand their geographical reach and racial diversity

DTx manufacturers are taking advantage of the new regulatory flexibility, afforded by the COVID-19 pandemic, to pilot new products and generate real-world evidence to support regulatory filing and reimbursement.