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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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FDA suggests ways to curb constraints with rare disease gene therapy trials

Pharmaceutical Technology

In 2020, the FDA released a guidance document for the industry with recommendations for sponsors developing gene therapies for rare diseases. This document delved into aspects related to manufacturing, preclinical, and clinical trial design for all phases of clinical development.

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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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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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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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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.

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MindMed aims for Nasdaq listing after Compass’ magic mushroom-fuelled IPO

pharmaphorum

COMP360 is a crystalline formulation of psilocybin in phase 2b clinical development in patients who have not responded to standard therapy for depression. UK-based Compass has a patented synthetic version of psilocybin, the active ingredient in magic mushrooms, and raised around $127.5

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