Europe – EMA finalizes guidance on parallel MAA, EU-M4all procedure

The European Medicines Agency (EMA) on Thursday released the final version of its guidance detailing the agency’s procedure for parallel EU-M4all (Article 58) and...

Europe – Clinical Trials Information System reaches major milestone towards go-live and application of...

EMA’s Management Board confirmed that the clinical trial EU Portal and Database, one of the main deliverables of the Clinical Trial Regulation and the key component of the Clinical Trial Information System...
European Pharmacopoeia revises general chapter on degree of coloration of liquids

Europe – New OCABR guidelines on COVID-19 recombinant spike protein vaccines and non-replicating adenovirus-vectored...

The new Official Control Authority Batch Release (OCABR) Guideline for Pandemic COVID-19 Vaccine (Recombinant Spike Protein), containing the agreed list of tests to be performed...

UK – Novartis’ MS therapy Kesimpta wins NICE backing

Kesimpta (ofatumumab) is the first self-administered, targeted B-cell therapy licensed for adults with relapsing forms of MS with active disease, according to Novartis. In its...
European Pharmacopoeia revises general chapter on degree of coloration of liquids

Europe – Pharmeuropa 33.2 : les titulaires de CEP invités à commenter les projets...

Les titulaires de CEP sont invités à consulter la liste des substances pour lesquelles est publié, dans Pharmeuropa 33.2, un projet de révision de la monographie...

Europe – COVID-19 Vaccine Janssen: EMA finds possible link to very rare cases of...

At its meeting of 20 April 2021, EMA’s safety committee (PRAC) concluded that a warning about unusual blood clots with low blood platelets should...

International – Real-world data suggests Sputnik V vaccine is 97.6% effective, says RDIF

The new efficacy rate is based on the analysis of data from 3.8 million Russians vaccinated with both components of Sputnik V from between...

UK – NICE unveils new strategy to improve patient access to innovative treatments

The five-strategy, launched today, will seek to transform ‘key elements’ of its approach to the latest and most effective treatments, while maintaining robust and...
Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) - updated information

Switzerland – CureVac Swiss AG submits application for authorisation of COVID-19 vaccine (CVnCoV) to...

With the rolling review procedure, Swissmedic evaluates the scientific data as soon as they become available and are submitted by the companies concerned. CureVac...

Europe – CureVac outlines COVID-19 vaccine production plans ahead of regulatory approval

CureVac CEO Franz-Werner Haas told CNBC last week that the company is planning for approval in the EU in the second quarter, depending on the...

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