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How ICH E6 (R3) is changing clinical trials

Pharmaceutical Technology

To explore how Zelta can support your organization’s clinical data management needs, download the document below. References: [link] [link] Free Report Confidence in Clinical Trials Amid Complexity and Change Download this free report to learn more about how to build confidence and flexibility in clinical trial data management.

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The unsustainability of clinical trials and need for transformative change

Pharmaceutical Technology

Trials intended for FDA submission must include patients representative of the US population While clinical trials can be conducted in multiple regions throughout the world in order to increase the pool of eligible patients, the proportion of US patients in applications submitted to the US FDA has been declining.

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Cell and gene therapy: The vital role of logistics

Pharmaceutical Technology

For gene therapy in the US, there are eight FDA-approved oncologic treatments, with prices ranging from $65,000 to $475,000. In addition, documentation of the material is required, along with clearly defined next steps for modification and expansion. However, costs can soar even higher.

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GSK’s Blenrep US comeback hindered by eye safety concerns

Pharmaceutical Technology

Robert Barrie July 16, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook Shares in London-listed GSK closed 1.19% down following the document release. Robert Barrie July 16, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook Shares in London-listed GSK closed 1.19% down following the document release.

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Sino Biopharma spends $951m to acquire China-based LaNova Medicines

Pharmaceutical Technology

The net payment made by Sino to acquire LaNova will be approximately $500.9m, a figure that excludes the estimated cash and bank deposits, according to a company document outlining the terms of the transaction. At the time, Sino spent 142 million yuan ($19.80m) to initiate its ownership involvement with the biotech.

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Can rare disease research in the US thrive under the new administration?

Pharmaceutical Technology

As one FDA initiative works to sustain the momentum of rare disease research, other events threaten to slow progress. Manasi Vaidya July 18, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook Credit: [H_Ko]/Shutterstock.com In 2024, 50% of the novel drugs approved by the FDA had an orphan drug designation.

FDA
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GSK’s Blenrep faces setback as FDA cancer committee votes against approval

Pharmaceutical Technology

Abigail Beaney July 18, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook The FDA’s Oncologic Drugs Advisory Committee (ODAC) has voted against the benefit/risk profile of GSK’s Blenrep. Syngene’s expertise in the field is covered in this white paper. You will receive an email shortly.

FDA