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Astellas Drug Acquired in $5.9B Deal Wins FDA Approval in Vision-Loss Disorder

MedCity News

Izervay, a drug developed by Astellas Pharma subsidiary Iveric Bio, is now the second approved therapy for the degenerative vision-loss disorder geographic atrophy. The regulatory decision comes as safety concerns emerge around the first therapy for the disease, an Apellis Pharmaceuticals product.

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Navigating Regulatory Challenges in Pharma Marketing: Best Practices

Pharma Marketing Network

The pharmaceutical industry operates in a highly regulated environment, where marketing and advertising practices are subject to rigorous scrutiny. Navigating these regulatory challenges is essential to ensure compliance, maintain trust, and effectively communicate the benefits and risks of pharmaceutical products.

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Leading freeze-drying systems suppliers for the pharmaceutical industry

Pharmaceutical Technology

Freeze drying is a crucial technique to prolong the shelf life of pharmaceutical products. Also known as lyophilisation, the technique stabilises and preserves sensitive products such as biologics, and diagnostic kits, in a permanently storable state.

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Data integrity considerations in Pharma and Life Sciences

European Pharmaceutical Review

In the pharmaceutical/life sciences industries, maintaining data integrity is crucial given its role in making critical decisions that shape outcomes from drug development to human health. What is the biggest impact of having compromised data when working with regulatory bodies in the pharmaceutical industry? How can this be mitigated?

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Navigating Regulatory Challenges in Pharma Marketing: Best Practices

Pharma Marketing Network

The pharmaceutical industry operates in a highly regulated environment, where marketing and advertising practices are subject to rigorous scrutiny. Navigating these regulatory challenges is essential to ensure compliance, maintain trust, and effectively communicate the benefits and risks of pharmaceutical products.

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Getting ahead of regulatory changes around PFAS in pharmaceutical packaging

Clarivate

These molecules of interest also impacted the pharmaceutical industry, and pharmaceutical companies faced a requirement to rapidly adopt risk mitigation plans to monitor the presence of nitrosamines in drug products. However, this regulatory ban does not impact active pharmaceutical ingredients (APIs).

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The Traditional Pharma Model Isn’t Working – It’s Time to Evolve!

PharmaKinnex

The Traditional Pharma Model Isn’t Working – It’s Time to Evolve! The pharmaceutical industry of 2022 is very different from the space that we all knew in 2012, 2016, or even 2020. What are these new and existing pharma regulations, expectations, and challenges? COVID-19, Telemedicine, & The New Pharma Landscape.

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