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FDA Focus on the Safety of Gene Therapy Products

Within the past 6 years, the US Food and Drug Administration (FDA) has approved a growing number of cellular and gene therapy products to treat a variety of conditio...
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Transparent, Pret-a-porter Operations Quality Measurement & Other 2024 Priorities for Drug Manufacturers & the Supply Chain

In Life Sciences manufacturing quality and compliance, the global digitalisation drive continues a-pace as the pressure builds to innovate, collaborate and contain c...
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Achieving GCP Compliance in Oncology Trials: The Balance between Obligation, Idealism and Realism

Compliance with GCP provides assurance that the data and reported results of clinical investigations are credible and accurate and that the rights, safety, and confi...
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Enhancing the Data Journey in Oncology Clinical Trials

Clinical trials are the springboard for progress in modern healthcare, guiding the development and evaluation of new treatments and next-generation therapies for pat...
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Regenerative Medicine: Hype and Hope or Safety and Efficacy?

Regenerative medicine, and the underlying stem cell technology on which it is based, offer considerable hope to patients suffering from trauma and acute or chronic d...
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Revolutionising Hypertension Management Through Personalised, Data-driven Dose Optimisation

In the late 1990s, Pfizer’s revenue stream was predominantly fuelled from the sales of antihypertensive drugs. The climax, so to speak, of its rigorous anti-hyperten...
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Diabesity: Implications for Treatment and Drug Development

The term “diabesity” has been used to refer to the twin pandemics of type 2 diabetes (T2D) and obesity.1 It was originally used after experiments showed that overfee...
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Emerging Treatments for Spinal Cord Damage

Injuries to the spinal cord can cause permanent paralysis and even lead to death, with little or no hope of regaining lost functions once the trauma has occurred. Ne...
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Precision Medicine: Targeted Therapy in Paediatric Oncology Patients

For several decades, cancer has been one most of the devastating diseases affecting paediatric patients. A huge number of clinical trials and research papers are aim...
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Global Outsourcing and Vendor Management: Key Influence Factors and Strategies

Few would argue that global outsourcing is accelerating at an increasingly rapid pace. But what does outsourcing really mean to business, and what is it worth? By...
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