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The rolling review will assess CVnCoV’s efficacy and immunogenicity data as it becomes available, speeding the decision process for an eventual marketing authorisation application.
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The Indian drug company pleaded guilty to concealing and destroying records containing evidence of its Kalyani plant manufacturing drugs in contravention to FDA requirements prior to a 2013 inspection.
YuflymaTM (CT-P17) has been approved for the treatment of thirteen chronic inflammatory diseases, including rheumatoid arthritis, ulcerative colitis and psoriatic arthritis, in Europe.
Outlining the most common comments from drug manufacturers, the Parenteral Drug Association (PDA) and US Food and Drug Administration (FDA) on the USP draft chapter for recombinant Factor C ().
The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) began two new reviews and wrote guidance for healthcare professionals on the potential side effects of Strimvelis, Venclyxto and Zolgensma.
In this issue we discuss whether clinicians know enough about the development of biosimilars to buy in, explore the biggest M&A trends in pharma and what to expect this year and consider the importance of disaccharides in the stabilisation of biologics. The journal also features articles on the fundamentals of…
The approval makes Ogluo™ Europe’s first ready-to-use liquid glucagon for rescuing diabetic patients from severe hypoglycaemic events.
The Discovery® BIO wide pore reversed-phase HPLC columns and capillaries provide sensitive, stable, efficient and reproducible separations.
The European medical cannabis market lacks a common regulatory framework; Peter Kohut charts a route through the complexity and highlights opportunities for the taking.
This application note outlines an LC-MS/MS method for analysing all 20 amino acids, without derivatisation, utilising the Supel™ Carbon LC column.
The Emergency Use Authorization (EUA) for bamlanivimab and etesevimab was based on a trial where the antibodies lowered risk of hospitalisation and death in COVID-19 patients.
The Scottish Medicines Consortium has approved Zeposia® (ozanimod) for use in relapsing remitting multiple sclerosis patients.
Breyanzi (lisocabtagene maraleucel) was approved on the 54 percent complete remission rate achieved in diffuse large B-cell lymphoma trials.
Pharmaceutical counterfeiting brought to the fore, as more than 3,000 saline filled vials being sold as COVID-19 vaccines were seized in Chinese police raids.
Pembrolizumab with pemetrexed and platinum chemotherapy has been recommended by NICE to treat non-squamous, non-small cell lung cancer.
