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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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Regs & Legs
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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.
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EU and US agree preliminary tariffs deal
Marking the first step in the negotiation process, this deal establishes key parameters of the final political agreement on trade and tariffs between the EU and US.
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Pharma Horizons: leading-edge formulation
This report addresses the key factors shaping pharmaceutical formulation, including regulation, QC and analysis.
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What will shape the Pharma landscape in Q3 2025?
Upcoming drug approvals and clinical progress will be pivotal during the third quarter of the year, says GlobalData.
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World-first legislation backs decentralised manufacturing
The landmark regulation establishes a future where highly personalised treatments are part of routine care, says MHRA’s Chief Executive.
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MHRA approves needle-free allergy drug alternative
The MHRA's approval provides eligible patients with a novel delivery method that is convenient and non-invasive.
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UK Government publishes Life Sciences Sector Plan
While a focus on accelerating access for innovative medicines has been welcomed, industry representatives caution that current system infrastructure could hinder the plans proposed by the UK Government.
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NICE recommends innovative cystic fibrosis therapy
Recommendation of the once-daily triple therapy increases the number of eligible cystic fibrosis patients who can access treatments in the UK.
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Updated licensing agreement marks “major milestone” in global HIV response
The expanded agreement between ViiV Healthcare and Medicines Patent Pool (MPP) provides a more patient-centric treatment approach for HIV patients worldwide.
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Advancing endotoxin testing with sustainable recombinant LAL solutions
The pharmaceutical industry faces mounting pressure to modernise its testing methods, driven by concerns over animal welfare, sustainability, and the need for more reliable results. Following a recent webinar, Fujifilm Wako discusses its Pyrostar™ Neo+ reagent and reveals how recombinant technology is transforming endotoxin testing while addressing evolving industry demands.
