Pharmaceutical News and Updates

Pediatric Applications in Europe

The European Medicines Agency (EMA) has released updated guidance titled “Procedural Advice on Paediatric Applications” to assist stakeholders in submitting applications for paediatric medicines in accordance with Regulation (EC) No 1901/2006 (Paediatric Regulation). Revised on 15 April 2025, this key document details the process for submitting, modifying, and managing Paediatric…

EMA meets industry stakeholders on scientific advice and clinical trial coordination

On 3rd July 2025 EMA conducted its annual meeting with representatives of industry stakeholders to address topics of evidence generation along the medicine’s life cycle and related product-development support activities, such as scientific advice and qualification, as well as specifics for paediatric and orphan medicines. The aim of this…

CTA Applications in Europe

What distinguishes Pharma Design from other service providers is that we offer cost-saving, targeted and dedicated support with a team of very specialised consultants. Our prices are competitive thanks to our lean and flexible business model, much more competitive than your usual CRO or service provider! We have assisted large…

Serious clinical development players should avoid ‘hype’ and ‘hope’

Hype and hope are markers of bias and should be excluded from the scientific method. This approach has been obvious since the 19th century, when the most ‘revolutionary’ early researchers have been skeptical about their own findings until evidence was overwhelming and public acceptance/benefit of an innovation was confirmed. Markers…

Individualised mRNA cancer immunotherapies do not meet the definition of vaccines, so stop calling them so.

Individualised mRNA cancer immunotherapies do not meet the definition of vaccines, therefore the very sexy terminology of ‘cancer vaccines’ is inappropriate. MHRA’s clarifies own definitions (https://assets.publishing.service.gov.uk/media/6799ef4d9a6dc0352ab34225/Individualised_mRNA_cancer_immunotherapies_0.6.5.pdf). More appropriately, MHRA states that such products are individualised mRNA cancer immunotherapies that use lipid nanoparticle delivery systems, and the current scope is confined…

Paediatric Plans across Europe

A paediatric investigation plan or PIP is a requirement for any marketing authorisation application in Europe (EU, Switzerland and UK). Even in cases where the medical condition targeted may benefit from a class waiver, any company planning a market launch in Europe needs to prepare a PIP in advance and…