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FDA tightens use of Pfizer, Moderna and Novavax COVID-19 vaccines
RFK Jr hits Comirnaty, Spikevax and Nuvaxovid with revised approvals for ‘high risk’ individuals.
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Regs & Legs
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Pharmacopeial Discussion Group releases major particulate contamination update
Revisions to the harmonised general chapter “Particulate Contamination (Q-09)” aim to improve pharmaceutical drug development.
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UK yet to agree on VPAG scheme following accelerated review
While no other country has an identical scheme, analysis of the 2025 payment rate shows the UK is significantly behind comparable countries.
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Understanding European regulatory requirements for low-GWP propellant transition
The paper explores recent guidance by the EMA and aims to help companies ensure their developments are efficient and effective for the forthcoming transition.
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Merck’s SpringWorks Therapeutics gains European approval for Ogsiveo
The drug is the first treatment for desmoid tumours to be approved in the region.
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Pharma cautious about rushing towards direct-to-consumer drug sales
Disruption to traditional distribution channels is anticipated to hinder widespread adoption of the channel.
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WuXi Biologics granted novel authorisation for commercial biologic manufacturing in Ireland
The EMA’s decision permits WuXi Biologics to progress with commercial manufacturing of a global client’s innovative biologic.
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Sanofi’s Tzield type 1 diabetes immunotherapy wins UK first
Becomes the first monoclonal antibody for the condition to be approved by the MHRA and advances the pharma company’s ambitions in diabetes.
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Resilient supply, reliable care: safeguarding Europe’s generics in an uncertain world
In this article, Michal Nitka, Senior Vice President, Head of Generics Europe & Global Head OTC, Teva Pharmaceuticals, outlines how policy reform, digital innovation, and manufacturing resilience can secure sustainable access to essential treatments - ensuring generic medicines remain a cornerstone of equitable, reliable care.
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Trump executive order targets US pharma supply chain resilience
Calls for active pharmaceutical ingredient (API) stockpile to cover around 26 ‘critical drugs’.
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EU Biotech Act public consultation opens for input
The European Commission hopes its planned legislation will enable biotechnology companies to bring products from laboratory to market more quickly.
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AI Act: data governance and compliance strategy implications in Pharma
In this article, Patrice Navarro, Tech Partner (Healthcare & Life Sciences Sector), Clifford Chance, discusses the AI Act and the related compliance considerations for pharmaceutical companies in the EU.
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AI driving automated microbiological testing market growth to 2033
Regulatory pressures and demand for trained operators is expected to hinder growth of the rapid microbiological testing market into the next decade, research suggests.
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Amid FDA turmoil Sarepta’s gene therapy worries begin to ease
But the impact of George Tidmarsh’s CBER appointment after Vinay Prasad’s abrupt resignation remains to be seen.
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Broad label FDA approval for phenylketonuria drug
Alongside Phase III data demonstrating significant efficacy in the rare disease, the FDA’s decision could position the small molecule as a future standard of care.
