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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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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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Data integrity considerations in Pharma and Life Sciences

European Pharmaceutical Review

Regulatory bodies such as the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) place great importance on data integrity in the pharmaceutical/life science industry. What is the main recommendation you would make to the pharmaceutical/life science industry to ensure a strong data governance framework?

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Why There's No Such Thing as a 'Safe' Drug?

Contrarian Sales Techniques

Clinical studies play an essential role in determining the safety and efficacy of new drugs before they can be approved for the public. The results of these studies are carefully analyzed and scrutinized by regulatory bodies, such as the FDA in the United States. This is before a drug can be approved for public use.

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Everything You Need to Know About Market Access in China

PM360

Given China’s status as the world’s second most populous nation and an economic powerhouse, it represents both a monumental market opportunity and a dynamic arena of challenges for pharmaceutical products. Regulatory body – NMPA : all pharmaceutical products sold in the Chinese market need to be granted market authorization by NMPA.

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RFID: The future of smart labelling?

Pharmaceutical Technology

Various uses soon became apparent including those for supply chain management, anti-counterfeiting, and to improve patient safety. He adds that in the early 2000s there were no set standards for RFID in the pharma industry, so the compatibility between systems was not guaranteed.