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AstraZeneca’s Forxiga approved in EU to treat chronic heart failure
The European Commission has approved Forxiga (dapagliflozin) for use in the EU to treat symptomatic chronic heart failure with reduced ejection fraction.
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European Medicines Agency (EMA)
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Approval of regulatory starting materials
There are significant interpretational differences between the European Medicines Agency (EMA) and US Food and Drug Administration (FDA)’s guidance on active pharmaceutical ingredient (API) starting materials. In this article, Dave Elder explores the ambiguity in guidance from both agencies and addresses why industry struggles to identify and justify starting materials…
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Biologics: a leadership journey
Behind every technological advance there is often a leadership story just as interesting. In this article, Ben Woollard highlights key leadership behaviours that have been fundamental in biological innovation and suggests how businesses can implement these attributes to strive forward in a new era of biologics.
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Availability of critical medicines during pandemics
The impact of COVID-19 is wide-reaching with disruptions to supply chains likely to continue over the coming years. In this article, Dave Elder discusses the effect of the pandemic on the supply and demand of critical medicines and what this means for pharma supply chains.
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EMA recommends 10 medicines for approval in October meeting
Ten medicines have been recommended for marketing authorisation and 10 extensions of indication have been suggested by the EMA.
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EMA begins rolling review of BNT162b2 COVID-19 vaccine
The rolling review of BNT162b2 will allow the committee for human medicines (CHMP) to reach a faster decision on a future marketing authorisation application.
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EMA begins rolling review of AstraZeneca COVID-19 vaccine
The EMA's human medicines committee has initiated a rolling review of AstraZeneca's COVID-19 vaccine candidate to test its efficacy.
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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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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.
