news
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.
List view / Grid view
Regulation & Legislation
news
Merck’s SpringWorks Therapeutics gains European approval for Ogsiveo
The drug is the first treatment for desmoid tumours to be approved in the region.
news
Pharma cautious about rushing towards direct-to-consumer drug sales
Disruption to traditional distribution channels is anticipated to hinder widespread adoption of the channel.
news
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.
article
Scaling for the GLP-1 revolution – meeting global injectable demand
In this article, Miguel Angel Ortega Sánchez of ROIS explores how the industry is adapting to new delivery formats, device bottlenecks, and strategic partnership models — and why flexibility, compliance, and tech transfer agility are now critical to success.
news
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.
webinar
The future of contamination control in pharma: from compliance to innovation
15 August 2025 | By Bruker Microbiology & Infection Diagnostics
This webinar explores the benefits of accelerated microbial identification using MALDI-TOF in pharmaceutical contamination control strategies.
article
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.
news
Vinay Prasad returns to lead vaccines and cell and gene therapy at the FDA
CBER head makes surprise comeback just weeks after his abrupt resignation.
webinar
Best practices for PUPSIT assembly design and operation
11 August 2025 | By Entegris
This webinar explores the design and implementation of pre use post sterilisation integrity test assemblies (PUPSIT) in sterile filtration processes to ensure regulatory compliance while minimising operational risk.
news
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.
article
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.
news
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.
article
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.
news
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.
