Commercialisation & Medical Affairs

Nicole Dale

The EU Biotech Act Puts Medical AI Safeguards at a Crossroads

Pharmatica image of a petri dish filled with blue liquid and ringed by twelve gold stars, with a single red drop sending ripples across the surface. It illustrates the EU Biotech Act and the debate over medical AI safeguards.

The EU Biotech Act aims to accelerate biotechnology development. Explore how proposed medical AI reforms could affect patient safety, compliance, and pharma competitiveness.

Nicole Dale

An Overview of EuroQol EQ-5D: Quality-of-Life Assessment

Pharmatica visual of an abstract blue five-bar health scale glowing on a bright background, representing EuroQol EQ-5D quality of life measurement.

EuroQol EQ-5D explained: How it measures quality of life, supports QALYs and HTA decisions, and what new EuroQol tools mean for clinical trial strategy.

Nicole Dale

CMS Finalises Medicare GLOBE to Rewrite Drug Pricing

Pharmatica image showing a pharmaceutical medicines vial and abstract international pricing benchmark concept representing the Medicare GLOBE drug payment model.

The Medicare GLOBE drug payment uses international drug prices to reshape selected Medicare Part B rebates. Here is what the final CMS rule means for pharma.

Nicole Dale

ICH M12 Drug Interaction Studies: EMA Targets the Gut Gap

Pharmatica image of a bright pharmaceutical laboratory bench with glass vials and a soft red ribbon, representing ICH M12 drug interaction studies and the EMA gastrointestinal guideline.

The EMA’s draft guideline extends ICH M12 drug interaction studies to the gut. See what it asks on food effect, gastric pH, and excipients, and how to respond.

Nicole Dale

More Than Conjugation: ADC Manufacturing

Pharmatica image of an ADC manufacturing facility showing antibody-drug conjugate drug product production and pharmaceutical processing equipment.

ADC manufacturing is becoming more complex as payloads, conjugation, lyophilisation, containment, and scale-up reshape CMC strategy and commercial readiness.

Nicole Dale

What Sponsors Need to Know About UK Combined Review 2026

Pharmatica image for UK Combined Review clinical trial approval showing coordinated MHRA and ethics assessment through a unified CTIMP regulatory pathway.

UK Combined Review unifies MHRA and ethics review for CTIMPs, reshaping approval timelines, submissions, and sponsor planning under UK trial reform.

Nicole Dale

Ketryx and Accenture Build Regulated AI MedTech at Scale

Pharmatica image of regulated AI connecting medical device software development, validation, traceability, and regulatory compliance.

Ketryx and Accenture are combining AI-native compliance infrastructure and transformation expertise to help MedTech scale regulated AI without slowing development.