Remove Food and Drug Administration Remove Manufacturing Remove Safety
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Modifier gene therapy – clinical development and manufacturing considerations

European Pharmaceutical Review

In April 2024, Ocugen received US Food and Drug Administration (FDA) clearance to initiate the Phase III liMeliGhT clinical trial for OCU400 for retinitis pigmentosa. Ocugen is currently enrolling patients in the Phase I/II ArMaDa clinical trial to assess the safety and efficacy of OCU410 for GA secondary to dAMD.

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How did pharma develop a vaccine so quickly?

World of DTC Marketing

Both the Pfizer and Moderna vaccines copied RNA sequence from the virus genome and found a way to manufacture it at scale with high-level processes and quality control. All vaccines go through clinical trials to test safety and effectiveness. 1455NO-HEALTH-CORONAVIRUS_VACCINES_PFIZER_O_.

Pharma 307
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Drug safety driving pyrogen testing market expansion

European Pharmaceutical Review

Additionally, the authors highlighted that a greater number of pharmaceutical and biotechnology contract manufacturing organisations (CMOs) has broadened the opportunities for providers of pyrogen testing services. This was attributed to their “highly sensitive and specific” testing capabilities.

Safety 94
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Should we be worried about pharma’s supply chain?

World of DTC Marketing

The goal of getting a drug to market as fast as possible so they can recoup drug development costs has the potential for mistakes that could cost lives. Coupled with all this is the continued outsourcing of raw materials and other steps in drug development. We need a 21st-century approach that puts patient safety first.

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FDA guidance highlights E&L considerations for ophthalmic drug products

European Pharmaceutical Review

Draft guidance published by the US Food and Drug Administration (FDA) in December 2023, discussed quality considerations for topical ophthalmic drug products, including key considerations for extractables and leachables (E&L) testing. This document is revised from a version published in October 2023.

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The internet enables misinformation on COVID

World of DTC Marketing

In some instances, vaccine-hesitant activists are manufacturing stories of deaths related to the vaccine that never happened. Also cited was a lack of trust in the government to ensure the vaccines’ safety and effectiveness. The major concerns for hesitancy included worries over side effects and that the vaccine is too new.

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FDA releases analysis on drug product quality in 2022

European Pharmaceutical Review

The Office of Pharmaceutical Quality (OPQ) in the US Food and Drug Administration (FDA)’s Center Pharmaceutical Quality for Drug Evaluation and Research (CDER) has released its 2022 annual report analysing drug manufacturers and their products.