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EMA recommends seven medicines for approval after September meeting
Following its latest meeting, the EMA's CHMP has suggested granting marketing authorisation to seven medicines and extending the indications of 15 others.
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European Medicines Agency (EMA)
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Post-Brexit product supply: which way next for pharma?
Cecilia Avram details the requirements for pharma companies post-Brexit and provides practical pointers on minimising the disruption to cross-border product availability as new rules come into force.
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Promising interim results from ALS study testing IPL344
The data suggests disease deterioration was halved in the six Amyotrophic Lateral Sclerosis (ALS) patients treated with IPL344 over eight months.
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Imfinzi approved in EU to treat extensive-stage small cell lung cancer
Imfinzi (durvalumab) has been approved by the European Commission as a first-line treatment for extensive-stage small cell lung cancer, with chemotherapy.
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Dexamethasone Taw application to treat COVID-19 to be evaluated by EMA
Dexamethasone Taw will be examined by the EMA on an accelerated assessment timetable, to assess whether it should be given to patients with COVID-19.
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EMA safety committee recommends withdrawal of ulipristal acetate marketing authorisation
The EMA's PRAC has recommended the revocation of the marketing authorisation for ulipristal acetate, after a review confirmed liver injury caused by the medicine.
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Improving quality in investigator‑led clinical trials
Laura Trotta explains why risk-based quality management is the best strategy to ensure data integrity of information from investigator-led clinical trials.
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Vertex’s Kaftrio approved for use in Europe and made accessible on the NHS
The European Commission and European Medicines Agency have approved the triple combination Kaftrio for use in certain cystic fibrosis patients, triggering the drug to be accessible on the UK’s National Health Service.
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NDMA: a recall trigger for the drug development industry
Product recalls due to contamination issues can be extremely costly for companies, in addition to the associated health implications. In this article, Marc Baiget Francesch explores the potential risks associated with N-nitrosodimethylamine (NDMA) contamination, why is it such a frequent contaminant and how to detect and eliminate the risks.
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EMA accepts marketing application for Spinal Muscular Atrophy treatment
The European Medicines Agency (EMA) has accepted the marketing authorisation application for Evrysdi™ (risdiplam) as a treatment of spinal muscular atrophy (SMA).
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Why pharma firms would benefit from a modular approach to working with product labelling
According to David Bennett, securing and building trust in the label, brand and process of a highly regulated industry player in a complex age will demand a new approach.
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EC approves subcutaneous formulation of Remsima®
The European Commission has granted marketing authorisation to Celltrion's Remsima (infliximab, CT-P13) subcutaneous formulation.
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EMA initiates review of dexamethasone for treating COVID-19
The EMA has begun to review dexamethasone to provide an opinion on the results of the RECOVERY study for the treatment of adults admitted to hospital with COVID-19.
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EMA recommends 11 new medicines for approval following July meeting
Dapivirine Vaginal Ring (dapivirine) and Blenrep (belantamab mafodotin) have been recommended for approval by the EMA's CHMP, along with nine other medicines.
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EMA to monitor real world use of COVID-19 treatments and vaccines
The EMA has built up an infrastructure to allow for the monitoring of COVID-19 treatments and vaccines used in clinical practice.
