Pharmaceutical News and Updates

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 18th 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…

We are hiring a business manager

We are looking for a business manager to work up to 3 days a week, from anywhere in the UK on a contract basis. RequirementsSignificant experience in the pharmaceutical services sector (Regulatory Affairs, Pharmacovigilance, Clinical Development) with a track record of winning contracts from the Pharma Industry and Biotech. Ability…

EMA/HTA parallel consultation platform

On 30 June 2017 the EMA and EUnetHTA launched the new EMA/HTA parallel consultation platform. The new guidance replaces the former draft best practice guide as of publication date and has been developed from the experience gained with the SEED project, the best practice on EMA/HTA parallel advice pilot from 2010 and the subsequent public…

Update to Orphan Product MAA variations

On November 18, 2016, EMA published an update to the post-authorisation guidance on MA extensions and type II variations to include further details on the information companies need to provide when submitting a Type II variation or a MA extension for an orphan-designated medicine. This follows the publication of a new…