Regulatory And Market Access Considerations With Drug Abuse Potential

Designing a comprehensive self-administration drug abuse liability study | Part II

Series Introduction Regulatory agencies require that any drug (parent or major metabolite) that penetrates the brain and has CNS activity, regardless of its therapeutic indication, be assessed for that drug’s abuse potential. In this series on Assessing Potential Drug Abuse, we are sharing how the team at Covance designs and setup accurate and …

Cancer Immunotherapy Trials

evaluation of immune response following treatment with Anti-CTLA-4 antibody, radiation therapy, or combination in murine model of breast cancer

Breast cancers are considered poorly immunogenic tumors, however, several approaches utilizing immunotherapies are being undertaken in the clinic to evaluate their potential for improving outcomes. Radiation therapy (RT) is a highly utilized clinical treatment modality in breast cancer. Radiation is known to modify the tumor microenvironment, induce cytokines and chemokines, …

Immuno-Oncology Studies

Emerging immuno-oncology therapies: life after checkpoint inhibitors

The clinical approval of biological therapeutics inhibiting CTLA-4 (ipilimumab), PD-1 (nivolumab, pembrolizumab) and PD-L1 (atezolizumab, avelumab, durvalumab) has ushered in a revolution in the field of cancer immunotherapy. Thus far, the approvals have occurred in a small number of cancer histotypes including melanoma, non-small cell lung cancer and urothelial cancers, …

Flow Cytometer blog

Flow cytometry based functional assays essential for characterizing biological significance

The efficacy of immune-modulating anti-cancer therapeutic antibodies that have been FDA-approved in recent years, such as anti-CTLA-4 and anti-PD-1, has driven growing interest in methods that provide a mechanistic understanding of drug function. Development of new mono and combination therapies with immune-modulatory effects requires more powerful immunophenotyping techniques capable of …

Pharmacovigilance & risk management for biosimilars: unique challenges & possible solutions

Biological medicines (biologics) have made substantial contributions to the treatment of many chronic and serious diseases such as cancers, chronic inflammatory diseases and some rare genetic disorders, and are expected to provide significant therapeutic benefits to many patients who would otherwise have had limited treatment options.

LabCorp expands drug development solutions with acquisition of Sciformix

Sciformix extends Covance’s pharmacovigilance capabilities for post-approval safety solutionsBURLINGTON, N.C.–(BUSINESS WIRE)–Jun. 11, 2018– LabCorp® (NYSE: LH), a leading global life sciences company, announced today that it has acquired Sciformix Corporation, a scientific process outsourcing company focused on pharmacovigilance and regulatory solutions for biopharmaceutical and medical devices clients. Sciformix will become …

Our polypharmacy state: understanding drug-drug interactions (DDIs) in the drug development process

Updated 2020. The FDA has now approved the DDI regulations. Below is the article as originally published. In 2018 the FDA and several other regulatory bodies are expected to enact and enforce more laws related to the requirements for nonclinical drug-drug interaction (DDI) studies prior to an IND. A key …