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

MedCity News

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

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Drug safety driving pyrogen testing market expansion

European Pharmaceutical Review

However, due to the importance of pyrogen testing for the safety of pharmaceutical products , the report stated that this will help to drive market growth. Researchers propose novel test for pyrogen detection The post Drug safety driving pyrogen testing market expansion appeared first on European Pharmaceutical Review.

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Pharmaceutical product positioning

eMediWrite

The process of giving a pharmaceutical product a unique identity on the market is called pharmaceutical product positioning. It entails recognising the special qualities and advantages of your product and conveying them to the intended market in a way that sets it apart from rival goods.

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Regulatory Compliance: Ensuring that pharmaceutical products meet all regulatory requirements and guidelines, including safety, efficacy, labelling, and post-marketing surveillance

eMediWrite

From the examination of raw materials through the release of the finished packaged product, Quality Control Authorities like Central Drugs Standard Control Organisation in India established under the Drugs & Cosmetics Act, 1940. They play a crucial role in assuring the efficacy and safety of products given to patients.

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The key role of GMP analytical testing for drug products

European Pharmaceutical Review

Analytical testing is an essential part of guaranteeing the quality, safety and effectiveness of pharmaceutical products. During the manufacturing processes, pharmaceutical products must be made correctly every time, due to the high level of regulatory oversight.

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Advancing endotoxin testing with sustainable recombinant LAL solutions

European Pharmaceutical Review

Cell and gene therapy products often possess extremely short shelf lives, making traditional multi-day testing protocols problematic. This creates demand for rapid, reliable alternatives that maintain safety standards while accommodating modern pharmaceutical development timelines.

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Navigating the regulatory challenge of PFAS for pharmaceutical manufacturers

European Pharmaceutical Review

This poses a significant challenge for pharmaceutical manufacturers, not least because of the technical challenges related to operations, supply chain and the environment. This article explores the potential impact of the proposal and considers how manufacturers can ensure the safety and reliability of their products.