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First-in-class plaque psoriasis oral therapy approved in EU
Bristol Myers Squibb’s Sotyktu is the only TYK2 inhibitor approved for the treatment of any disease in the European Union.
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Regulation & Legislation
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EMA publishes mid-point regulatory science strategy report
Progression in supporting development of precision medicine was noted as an achievement in a mid-term report on the EMA’s Regulatory Science Strategy to 2025.
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First mild asthma combination reliever approved in UK
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved the first dual-combination, inhaled corticosteroid and long-acting beta2-agonist reliever therapy for mild asthma.
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First gene therapy recommended for AADC
NICE's final draft guidance has recommended the first and only gene therapy for children with aromatic L-amino acid decarboxylase (AADC) deficiency.
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First FcRn blocker approved in UK for myasthenia gravis
VYVGART (efgartigimod alfa-fcab) has been approved for adults with generalised myasthenia gravis by UK Medicines and Healthcare products Regulatory Agency (MHRA).
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Parallel import of medicinal products: regulatory update
Andrzej Siwiec and Katarzyna Bajer of DBS Law discuss recent rulings on the parallel import of medicinal products in the European Union.
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SMC accepts treatment for chronic hepatitis delta virus
Bulevirtide has been accepted by the Scottish Medicines Consortium to treat chronic hepatitis delta virus (HDV) infection in adults.
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Learning from lecanemab: a breakthrough treatment
Here, Dr Michael Irizarry, Eisai’s Senior Vice President of Clinical Research and Deputy Chief Clinical Officer for Alzheimer’s Disease and Brain Health discusses its highly anticipated Alzheimer’s drug, lecanemab.
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Pharma responds to UK government Statutory Scheme rise
The ABPI and Lilly have responded to the UK government’s confirmed plans to increase the payment percentage in the Statutory Scheme to control the costs of branded medicines.
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New working party to address excipients in Ph. Eur. monographs
The European Pharmacopoeia Commission’s new Excipients Strategy Working Party will address specificities of excipients in European Pharmacopoeia monographs.
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EMA’s human medicines committee (CHMP) meeting highlights – February 2023
In its latest meeting, the Committee for Medicinal Products for Human Use (CHMP) recommended eight new medicines for approval, including an enzyme replacement therapy for a rare disease.
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Prioritising for a data-driven 2023
As the pharmaceutical industry continues to face unprecedented challenges, the need for greater regulatory compliance and process efficiency remains at the forefront. Here, Frits Stulp predicts how new waves of digital transformation can help support companies deliver the best possible patient outcomes.
whitepaper
Press release: Biopharmaceutical testing capabilities increasing in Switzerland
SGS have relocated their biopharmaceutical testing laboratory in Plan-les-Ouates, Switzerland.
whitepaper
Product hub: How can aseptic manufacturers prevent losses in the millions?
Highest precision with microbial air sampler MAS-100 Iso. So you can focus on the essential.
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CHMP recommends first pegylated enzyme for Fabry disease
A PEGylated enzyme replacement therapy for Fabry disease has received recommendation for a marketing authorisation from the European Medicines Agency (EMA)'s human medicines committee.
