article thumbnail

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.

article thumbnail

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.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

10 Key Learnings from Successful Cellular and Gene Therapy Trials for Rare Diseases

XTalks

Melanie Blank, clinical team leader for General Medicine Branch 1 at the US Food and Drug Administration’s (FDA) Division of Clinical Evaluation and Pharmacology/Toxicology (DCEPT), the agency is seeing one or two new applications coming in every week for new gene therapies for different diseases. Reference: Chung DC, et al.

article thumbnail

Novavax Announces COVID-19 Vaccine Clinical Development Progress

The Pharma Data

Two of the three planned late-stage efficacy trials for NVX-CoV2373 sponsored by Novavax are fully enrolled, and more than 20,000 participants have been dosed to-date. In alignment with Novavax’ commitment to transparency, Phase 3 clinical trial protocols are posted to the company’s website at Novavax.com/resources upon finalization.

article thumbnail

$5 million to fund trial of immunotherapy for uveal melanoma

Drug Discovery World

ISA103 was developed using the company’s Synthetic Long Peptide (SLP) technology, designed to fully harness and direct the body’s defense mechanisms towards fighting the disease. It contains multiple long peptides spanning the most immunogenic regions of the PRAME protein. . A total of 90 patients will be enrolled in the trial. .

Trials 52
article thumbnail

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. The trial was jointly conducted by Seagen and Astellas.

Antibody 130
article thumbnail

AZ resumes UK coronavirus vaccine trial

pharmaphorum

AstraZeneca has resumed UK trials for its coronavirus vaccine, after the country’s medicines regulator gave the all-clear following a safety scare. A UK safety committee has concluded its investigations and recommended to the country’s Medicines and Healthcare products Regulatory Agency (MHRA) that trials are safe to resume.