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A combination of mid-infrared spectroscopy and artificial intelligence (AI) achieved excellent prediction capability for inline pharmaceutical packaging content verification, a study has shown.
The European Commission has published its much-anticipated proposed revisions to the EU pharmaceutical legislation. While not as extensive as some had anticipated, with elements such as the supplementary protection certificate – the demise of which has been foretold for years – continuing albeit in a different form, Elisabethann Wright, Partner,…
A new route of administration for a biologic to treat ulcerative colitis (UC) has been approved in the US.
Pharmaceutical manufacturing in Europe is at risk of critical medicine shortages, states the European Federation of Pharmaceutical Industries and Associations (EFPIA), if the widest chemical substance restriction, concerning Per- and Polyfluoroalkyl Substances (PFAS), is put in place.
Altasciences’ Proactive Drug Development can accelerate the development of biologics by up to 40%, from lead identification to clinical POC.
Watch Altasciences’ on-demand webinar to learn the key advantages and differences of conducting early phase clinical trials in North America.
Pharmacovigilance regulation in the EU and beyond has continued to grow and become more stringent over the last decade. In this article, ICON’s Graeme Bones explains how to handle the different types of data migration methods and how companies can select the optimum approach to ensure data integrity is maintained.
Sandoz’s monoclonal antibody Tyruko® has been approved for all indications of reference medicine, as the first biosimilar to treat relapsing forms of multiple sclerosis (MS) in Europe.
Approval of BeiGene’s TEVIMBRA® (tislelizumab) in EU follows an agreement with Novartis to regain global rights of the antibody treatment.
The first IL-23p19 targeted biologic recommended by the National Institute for Health and Care Excellence (NICE) for moderately to severely active ulcerative colitis (UC) in adults in Great Britain is based on Phase III evidence of sustained clinical remission.
Adtralza®(tralokinumab) has been granted a UK marketing authorisation by the Medicines and Healthcare Products Regulatory Agency (MHRA) to treat atopic dermatitis, halving the number of injections required.
New recommendations from a report on antibiotic use and development has underlined key actions to help mitigate antimicrobial resistance (AMR) globally.
The first long-acting injectable PrEP option proven superior to daily oral FTC/TDF in reducing HIV acquisition, has been approved in the European Union (EU).
The US Food and Drug Administration (FDA) has granted approval of a treatment for anaemic patients with a rare blood cancer.
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.
