All European Medicines Agency (EMA) articles – Page 2
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NewsOxford/AZ COVID-19 vaccine to be discontinued
Considering reduced global demand for COVID vaccines, AstraZeneca has deemed there is no long-term value in investing in manufacturing the adenovirus-based vaccine.
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NewsPositive CHMP recommendation for antibiotic combination
EMA has recommended granting a marketing authorisation for Emblaveo for treatment of infections caused by multidrug-resistant bacteria.
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ArticleForward-thinking CDMO tackles the dynamic challenge of N-nitrosamines control with high-performance analytical instrumentation
Poland-based Polpharma API relies on Waters analytical instrumentation for impurities method development and testing to meet the ever-evolving regulatory guidance around N-nitrosamines (nitrosamines) control in active pharmaceutical ingredients (API).
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NewsCHMP meeting highlights: February 2024
Ten new medicines, including a new oligonucleotide therapy for ALS, were recommended for approval at the Committee for Medicinal Products for Human Use (CHMP)’s recent meeting.
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NewsEMA Annex 1 Q&A discusses bioburden considerations
In its recent responses to FAQs relating to Annex 1, the European Medicines Agency (EMA) discusses bioburden guidelines for good manufacturing practice (CGMP) and good distribution practice (GDP).
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ArticlePharmaceutical industry: 2023 in retrospect
In this article, Dave Elder delves deeper into some ongoing developments in topic areas highlighted in European Pharmaceutical Review (EPR) during 2023.
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ArticleBridging the healthcare digital divide: a gradual approach to adopting ePI
As the global healthcare landscape moves towards a digital transformation, a balanced approach that unites electronic product information (ePI) with traditional paper leaflets can help ensure every European citizen, irrespective of their digital access, has unencumbered access to critical medical information. Here, Ataa Elfaquih from MLPS, a subgroup of the ...
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NewsDriving QbD as a quality standard in drug development
To facilitate Quality by Design (QbD) in becoming a true standard approach for drug development, pharma should attend regulatory expectations and pursue innovative frameworks that guarantee high-quality levels, researchers urge.
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ArticleThe imperative of fridge-free vaccines
Bruce Roser of Stablepharma gives an overview of efforts to develop thermostable vaccines. Could ‘fridge-free’ formulations improve the cost-effectiveness and accessibility of vaccination?
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ArticleBioburden and sterility testing: how to conserve gene therapy product
Here, Kathy Zagaroli, Senior Director of Quality Control at Kiniksa Pharmaceuticals, and Tom Bujold, Senior Director of Quality Control at REGENXBIO, discuss the challenges of bioburden and sterility testing for gene therapies and why industry must come together to drive increased harmonisation.
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NewsEuropean regulators prepare for AI in pharma
A coordinated workplan, which runs to 2028 will help European regulators embrace opportunities for artificial intelligence.
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ArticleYear in review: EPR’s top stories of 2023
EPR wraps up the year with a selection of top stories from 2023, highlighting key trends and topics such as environmental monitoring (EM), quality (QA/QC), manufacturing, regulation and clinical development.
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NewsEurope publishes first list of critical medicines
More than 200 active substances are included on the list, which is seen as an important tool in preventing shortages of critical medicines in the EU/EEA.
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NewsCHMP recommends new immunotherapy delivery method
If approved, Roche’s Tecentriq subcutaneous (SC) would be the EU’s first injectable PD-(L)1 cancer immunotherapy.
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NewsMHRA authorises alopecia treatment
UK patients with severe alopecia areata could access Pfizer's enzyme inhibitor, Litfulo (ritlecitinib), to help treat their condition.
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ArticleMitigating medicines shortages in Europe
The pharmaceutical industry must work together, applying new initiatives and harnessing digital tools to address Europe’s medicines shortages in 2023 and beyond, regulators and other organisations assert.
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NewsCounterfeit diabetes pens identified in EU and UK
Following shortages of the diabetes medicine Ozempic (semaglutide), the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) have confirmed cases of falsely labelled pre-filled pens at UK and EU wholesalers.
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NewsAnti-PD-1 antibody gains EU approval for oesophageal cancer
Approval of BeiGene’s TEVIMBRA® (tislelizumab) in EU follows an agreement with Novartis to regain global rights of the antibody treatment.
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NewsCHMP’s September 2023 meeting highlights
In its September 2023 meeting, the EMA’s human medicines committee (CHMP) recommended nine medicines for approval and the extension of therapeutic indications for 11 medicines.
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NewsEuropean regulatory perspective on nitrosamine mitigation strategies
With nitrite concentration in excipients being a key risk factor in nitrosamine drug substance related impurities (NDSRI) formation, there is opportunity to implement corrective and preventative actions (CAPAs), EMA experts say.
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