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Navigating CAPA in Clinical Development: Ensuring Compliance and Quality Assurance

Advarra

When it comes to clinical development, precision, compliance, and quality assurance are paramount. For clinical development organizations, an effective CAPA serves as an essential compass, directing a path towards continuous improvement while maintaining steadfast regulatory compliance.

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Sandoz confirms late-stage clinical development plans for proposed biosimilar aflibercept, a key ophthalmology medicine

The Pharma Data

Sandoz, a Novartis division, today announced progress in the late-stage clinical development program for its proposed biosimilar aflibercept. Sandoz will begin enrolling the first patient in MYLIGHT, a clinical Phase III confirmatory efficacy and safety study, shortly 1. Disclaimer. About Sandoz.

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Novavax Announces COVID-19 Vaccine Clinical Development Progress

The Pharma Data

NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. We caution investors not to place considerable reliance on forward-looking statements contained in this press release.

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Merck wins regulatory approval for combination therapy to treat la/mUC

Pharmaceutical Technology

KEYTRUDA is an anti-PD-1 therapy developed by Merck, while Padcev has been developed by Astellas and Seagen. The combination therapy can be used to treat la/mUC patients who do not qualify for cisplatin-containing chemotherapy. Results showed that patients treated with Padcev along with KEYTRUDA achieved a confirmed ORR of 68%.

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Syncromune and Eucure enter antibody licence deal

Pharmaceutical Technology

According to the deal, the worldwide rights for developing and marketing intratumoral combination treatment containing Eucure’s YH002 and two additional active ingredients of the Syncrovax therapy will be acquired by Syncromune.

Antibody 130
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Sandoz confirms late-stage clinical development plans for proposed biosimilar aflibercept, a key ophthalmology medicine | Novartis

The Pharma Data

Holzkirchen, May 3, 2021 – Sandoz, a Novartis division, today announced progress in the late-stage clinical development program for its proposed biosimilar aflibercept. Sandoz will begin enrolling the first patient in MYLIGHT, a clinical Phase III confirmatory efficacy and safety study, shortly 1. Disclaimer. About Sandoz.

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Why Proactive AME Studies are Critical to Accelerating Your Approval Journey

Worldwide Clinical Trials

During clinical development, new chemical entities (NCEs) require an absorption, metabolism, and excretion (AME) study. Regardless of the formulation, the entire dose must be administered to each subject, and the dosing containers must be checked for residual radioactivity.