All Legal & Compliance articles – Page 3
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NewsNew partnership targets CNS symptoms in ultra-rare diseases
Chiesi Group and Key2Brain have signed a global license agreement to develop two blood-brain barrier-crossing enzyme replacement therapies for alpha-mannosidosis and Krabbe disease – with the aim to help patients with limited treatment options.
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NewsNew therapy for incurable brain disease heads to clinical trials
SynaptixBio has selected its lead drug candidate, SB H-19642, for clinical trials to treat H-ABC - a rare, fatal neurodegenerative disease with no current cure.
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ArticleWhy playing it safe is slowing down drug discovery
President Trump’s proposed drug pricing reforms are putting pressure on early-stage discovery. To keep pace, teams must rethink how they manage risk, resources and collaboration.
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ArticleA global push for better animal welfare in research
What does ethical research look like in drug discovery today? In this interview, Charles River’s Executive Director of Global Animal Welfare shares how global standards, the 3Rs and her own path as a woman in STEM are shaping efforts to reduce animal use in science.
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ArticleNew tRNA tech aims to rewrite rare disease treatment
Alltrna is redefining the future of rare disease treatment with engineered tRNA therapeutics that target genetic mutations - not just individual diseases. CEO Michelle Werner shares how this bold, mutation-driven approach could unlock universal treatments for thousands of patients long overlooked by traditional medicine.
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ArticleTransforming biotherapeutics delivery for local communities
Vitalant is transforming the path from preclinical drug discovery to patient care by enabling access to cutting-edge cell and gene therapies. With decades of expertise and a nationwide network, find out how they bridge the gap between innovative treatments and local communities, ensuring life-changing therapies reach patients efficiently.
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ArticleAllele-selective gene editing: a breakthrough in Huntington's disease treatment
Huntington's disease remains a major challenge, but allele-selective gene editing offers new hope. By targeting only the mutant gene, this approach could provide a one-time, durable treatment. Life Edit’s Dr Amy Pooler reveals how this innovative therapy could reshape HD treatment.
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ArticleBuilding the requisite clinical development infrastructure for medical innovation to thrive
Outdated clinical development systems are slowing breakthroughs like gene therapies and precision medicine. This article explores how a flexible, on-demand approach can accelerate drug development and bring innovations to patients faster.
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NewsRepurposed anti-inflammatory drug may help treat alcohol use disorders
A new study by Scripps Research reveals that apremilast, an FDA-approved anti-inflammatory drug, may help reduce both alcohol consumption and pain sensitivity, offering a potential dual therapy for alcohol use disorder.
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ReportBeyond the Lab: Clinical Trials
Explore how artificial intelligence (AI), biomarkers, and innovative trial technologies are creating a more efficient, data-driven future for drug discovery. From better patient selection to smarter trial design, see how clinical research is evolving to deliver new therapies faster.
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NewsNew leadership at ELRIG aims to expand collaboration across drug discovery
ELRIG, a UK-based scientific community driving innovation in drug discovery, has appointed biopharma leader Dr Del Trezise as its new Chair - signalling a bold new chapter for the organisation.
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ArticleSpirulina’s role in shaping the future of preventative biologics
From law to biotech, Brian Finrow's career path has been anything but conventional. As Co-founder and CEO of Lumen Bioscience, he’s steering the company’s innovative approach to drug discovery, focusing on preventative biologics that offer scalable, cost-effective solutions. Find out how Finrow's unique spirulina-based platform is changing the way we ...
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ArticleThe rising impact of biomarkers in early clinical development
Dr Cyril Clarke at ICON Biotech reveals how biomarkers are transforming early-phase clinical trials by offering valuable insights into the safety and efficacy of novel therapies.
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ArticleNext-gen biotech: rBIO’s approach to affordable insulin solutions
rBIO is transforming the biosimilar insulin market with a novel biomanufacturing platform designed to reduce production costs while maintaining high-quality standards. CEO Cameron Owen shares how their approach is shaping drug discovery and improving patient access to life-saving treatments.
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ArticleNavigating the AI revolution: a roadmap for pharma's future
AI-driven drug development, powered by advanced models and expanding data access, is becoming a reality. Learn why navigating regulatory hurdles and mastering biology’s inherent complexities are crucial to fully unlocking its potential.
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ArticleEmpowering women in STEM: Navigating CMC regulatory affairs
Discover how a leader in CMC regulatory affairs is transforming drug development and inspiring the next generation of scientists.
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ArticleThe future of cell therapy: scaling production for global reach
Scaling up cell therapy is no easy feat. PluriCDMO's Andy Lewin reveals the critical factors for success and how they are helping companies bring life-saving therapies to market.
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ArticleExperts explore the future of iPSC-based cell therapies
Discover the transformative potential of iPSC-based therapies in regenerative medicine, alongside their challenges including scalability, safety and targeted delivery.
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ArticleNew cell therapy model accelerates cancer treatment development
CTMC, a joint venture between Resilience + MD Anderson Cancer Center, is transforming cancer treatment with faster, more efficient cell therapy development - learn how they’re doing it.
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ArticleFDA’s Project Optimus: A new era in oncology drug dosing
Explore how FDA’s Project Optimus is reshaping oncology drug dosing strategies, with insights on precision medicine, adaptive trial designs, and the role of CROs in optimising patient outcomes.
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