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EU reviewers have recommended five new medicines and a pneumococcal vaccine for EU-wide approval. New uses of several approved medicines have also drawn the thumbs up, while the sponsor of a cancer drug has withdrawn its product from the review process.
As discussions continue over the European Commission’s plans to overhaul the EU pharmaceutical legislation, the R&D-based pharma industry body EFPIA says that any new pharma policy framework will need to be stable, fast, effective and globally competitive.
The “chronic disease paradigm” presents a real challenge for companies marketing advanced therapies.
Following Orphazyme’s disappointment in the US regarding its investigational drug for an ultrarare disease, the company has said it will need more time to address outstanding issues raised by EU reviewers about the same medicine.
Coronavirus Notebook: EMA Begins Assessing AZ’s Evusheld, Apeiron Starts Phase I Trial Of Inhaled APN01
The UK has explained its strategy for administering COVID-19 vaccines to people who have been partially immunized abroad.
Applications for the accelerated assessment of planned EU marketing applications for two drugs are being considered by the European Medicines Agency.
Proposals on medicines put forward by the European Commission are part of a package of measures to improve the implementation of the Northern Ireland Protocol by relaxing checks on goods moving across the Irish sea.
Value assessments of COVID-19 monoclonal antibodies should inform pricing decisions, says cross country coalition.
The European Medicines Agency is expecting a lively pipeline of advanced therapy medicines over the next few years. It is also making final preparations for the introduction of the new EU clinical trials system from the end of January next year.
A report beefing up the proposals contained in the European Commission’s Pharmaceutical Strategy has been approved by an influential parliamentary committee that wants to see a “stable, updated and safety-centered regulatory system” and an "autonomous and resilient" pharmaceutical industry.
Sponsors of six new products, including a first-in-class treatment for unresectable locally advanced or metastatic triple-negative breast cancer, will find out this week if their products are on course to be approved for use in the EU. Also, two sponsors might be asked to address last-minute questions about their drugs.
The company behind the CVnCOV COVID-19 vaccine candidate says the decision to withdraw from regulatory review is strategic. The EMA says outstanding issues affecting the benefit-risk balance remained to be answered at the time of withdrawal.
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