Pharmaceutical News and Updates
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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…
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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…
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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…
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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…
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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…
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The public consultation on Europe’s Paediatric Regulation
The Paediatric Regulation (Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products) was adopted in 2007 to address a serious gap in knowledge on…
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Reorganisational Change at EMA
The European Medicines Agency (EMA) has announced some organisational adjustments and important strategic amendments of its corporate management structure that will result in a leaner, more streamlined architecture and improved administrative support. Building on the…
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EMA publishes report on parallel Scientific Advice
EMA published a report on the pilot on its parallel regulatory-health technology assessment scientific advice with a Best Practice Guide. Background: Since 2010, the EMA has initiated a pilot project of parallel HTA-regulatory scientific advice,…
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ICH Readies new guidance
The Assembly finalised its rules of procedure, which reflect the new emphasis on clearer governance, transparency and openness in the operation of the reformed ICH, and will be published shortly. Key advances for public health…