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Europe

Set Alert for Europe

Gilead’s First-In-Class Drug For Aggressive Breast Cancer On Track For EU Approval

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 New uses of several approved medicines have also drawn the thumbs up, while the sponsor of a cancer drug has withdrawn its product from the review process.

Approvals Drug Review

EFPIA On Why More EU Drug Price Transparency Isn’t The Answer

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.

Europe Regulation

Confronting The Challenges Of Marketing Cell And Gene Therapies

The “chronic disease paradigm” presents a real challenge for companies marketing advanced therapies.

Europe North America

Orphazyme Wants More Time To Deal With Late-Stage Issues For Arimoclomol In EU

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.

Europe Drug Review

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.

Europe United Kingdom

Boehringer & BridgeBio Seek EU Fast-Track Status; Enfortumab Vedotin Reverts To Standard Review

Applications for the accelerated assessment of planned EU marketing applications for two drugs are being considered by the European Medicines Agency.

Europe Review Pathway

EU Revamps Plans To Ease Medicines Trade Between GB and NI

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.

Europe United Kingdom

European Countries Call For Health Technology Assessments Of COVID-19 Products

Value assessments of COVID-19 monoclonal antibodies should inform pricing decisions, says cross country coalition.

Europe Coronavirus COVID-19

Pandemic Drives Rise In EMA Scientific Advice, But New EU Drug Filings Slow

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.

Europe Research & Development

EU Committee Backs Collective Drug Price Talks, Early-Warning System For Shortages

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.

Europe Regulation

Gilead Awaits EMA Verdict On Trodelvy As It Whizzes Through EU Review

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.

Approvals Drug Review

CureVac Pulls Covid Vaccine From European Review Process

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.

Europe Coronavirus COVID-19
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