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The Importance of Regulatory Expertise in Generic Drug Development

Drug Patent Watch

Generic drug development is a complex process that requires a deep understanding of regulatory requirements and guidelines. Regulatory expertise plays a crucial role in ensuring that generic drugs meet the necessary standards for quality, safety, and efficacy. EU, and other regions. ” Scientific Research Publishing , 2024.

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Clinical research in 2021: A new era of collaboration and innovation

pharmaphorum

The pandemic has propelled the life science industry toward higher expectations for faster, more responsive and more inclusive drug development. It is likely we will begin to see the public ask more questions, which in turn may require more regular and ongoing communication efforts by industry stakeholders.

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Norstella, Citeline merge to create $5bn pharma tech firm

pharmaphorum

With the merger now completed, Norstella becomes a $5 billion group with 1,500 employees across the five business brands with the overarching objective of guiding life sciences companies through the drug development process so patients can get access to therapies more quickly. Photo by Edge2Edge Media on Unsplash.

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Prime Global appoints Emma Sutcliffe as SVP Patient Insights and Solutions

pharmaphorum

Prime Global, the international medical communications and market access group, has appointed Emma Sutcliffe as senior vice president, patient insights and solutions. Sutcliffe will lead on patient engagement and support Prime Global’s seven agencies and four consultancies to deliver patient-centric communications.

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The rising importance of containment in small molecule drug development

Pharmaceutical Technology

HPAPIs may now represent more than 30% of the drug development pipeline. Within that figure, GlobalData estimates that around 60% of pipeline HPAPIs are developed to target oncology. Between 2018 and 2020, 58% of the small molecule API contract manufacturing sites purchased worldwide offered containment.

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FDA suggests ways to curb constraints with rare disease gene therapy trials

Pharmaceutical Technology

In 2020, the FDA released a guidance document for the industry with recommendations for sponsors developing gene therapies for rare diseases. This document delved into aspects related to manufacturing, preclinical, and clinical trial design for all phases of clinical development.

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2022 spells change for EU pharmaceutical legislation

European Pharmaceutical Review

The review was impacted by Brexit and the COVID-19 pandemic, which compounded existing issues surrounding high drug pricing and patient access that had been brewing since 2016 and highlighted several shortcomings in the EU’s pharmaceutical system. pocket expenses account for only seven percent of the overall cost of developing drugs.