Conversations in Drug Development Trends

FEBRUARY 21, 2024

Also known as a human radiolabeled mass balanced study, the AME study aims to determine the overall metabolism and excretion pathways of the NCE, as well as to identify and quantify circulating metabolites relative to parent or total drug-related exposure.

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Codon

JANUARY 21, 2024

yellow fever, malaria, and dengue), evaluating new drugs or treatments, and studying pathogenesis, the process by which a disease develops. Human challenge trials were an indispensable part of the development of the malaria vaccine, R21/Matrix-M, endorsed by the World Health Organization last October.

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Advarra

AUGUST 16, 2022

Orphan drugs have historically faced a number of barriers, such as limited research and development (R&D) investment due to an expected lack of profitability as well as challenges in clinical trial design and recruitment. Before 1983, only 38 orphan drugs had received U.S. Food and Drug Administration (FDA) approval.

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NIH Director's Blog: Drug Development

FEBRUARY 16, 2021

These include drugs that you may have heard about on the news: remdesivir (an antiviral), dexamethasone (a steroid), and monoclonal antibodies from the companies Eli Lilly and Regeneron. Therapeutics Clinical Working Group : Prioritizes therapeutic agents for testing within an adaptive master protocol strategy for clinical research.

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Drug Target Review

OCTOBER 26, 2023

Alipogene tiparvovec and voretigene neparvovec-rzyl, two recombinant AAV-based gene therapy products, were approved by the European Medicines Agency (EMA) to treat lipoprotein lipase deficiency in 2012 2 and by the US Food and Drug Administration (FDA) to treat inherited retinal dystrophy in 2017, respectively. Russell S, et al. e419 (2023).

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The Pharma Data

APRIL 24, 2021

Novartis is advancing Research & Development of next-generation treatments to combat emerging drug resistance. In 2020, we discovered another novel malaria therapy, INE963, which has an entirely new mechanism of action and is expected to begin clinical trials in 2021. Working on next-generation antimalarials.

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Agency IQ

JUNE 9, 2023

What will the orphan drug market exclusivity haircut mean for industry? Here, we’re starting some deeper analysis of aspects of the proposal package with a look at the impact of orphan drug provisions, seeing what impact the new provisions and the surrounding uncertainty might have on innovation.

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The Pharma Data

NOVEMBER 10, 2020

Growing into a biopharmaceutical company, Innovent has built an integrated platform covering from drug discovery, CMC, clinical development and commercialization. Dr. Liu shared his over 30 years of R&D experience in drug development both in the global pharmaceutical companies and world renowned scientific research institutions.

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Biosimilars Clinical Trials International Clinical Development 52

Agency IQ

AUGUST 2, 2024

While the work on the pharma package will likely take quite some time, another deadline is coming up fast: the full transition of all clinical trials from the Clinical Trials Directive to the Clinical Trials Regulation.

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DrugBank

MARCH 22, 2024

There are many obstacles that you have to overcome on the road to success in early-stage drug discovery and drug repurposing research. As a result, the industry is turning to managed data sources and are having to weigh the costs and benefits of open data sources versus enterprise research tools.

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Licensing Licensing Research Production 74

The Pharma Data

JANUARY 26, 2021

“Notably, the 70 percent decrease in risk of hospitalizations or death seen in this Phase 3 trial of bamlanivimab and etesevimab together is consistent with the reduction in risk of hospitalization or ER visits seen with bamlanivimab alone in the Phase 2 trial. INDIANAPOLIS, Jan. Across 1,035 patients, there were 11 events (2.1

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Hospitals Treatment Trials Long-Term Care Facilities 52

Agency IQ

JUNE 7, 2024

While pre-pandemic, certain manufacturing facilities were required to comply with RRA records requests, the FDA only gained this authority to require compliance from BIMO facilities under the provisions of the Food and Drug Omnibus Reform Act (FDORA) in 2022. “To

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Codon

JUNE 2, 2024

Without mouse models, we may never have developed polio and meningitis vaccines, organ transplants, GLP-1 drugs, gene therapies , or any other number of transformative treatments. Today, somewhere on the order of 30 million rodents are used yearly in biomedical research in the U.S. C57Bl/6 mice in laboratory cages.

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