NIH Director's Blog: Drug Development

FEBRUARY 16, 2021

ACTIV was founded last April to accelerate drug research that typically requires more than a decade of clinical ups and downs to develop a safe, effective therapy. Cutting through the usual red tape and working with an intense sense of purpose, the partnership took a mere matter of weeks to set up its first four clinical trials.

Clinical Trials 52

Clinical Trials Trials Hospitals Vaccine 52

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.

Disease 52

Disease Clinical Trials FDA Approval FDA 52

The Pharma Data

APRIL 24, 2021

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. R&D partnerships to combat drug-resistant malaria in Africa. INE963 is a fast-acting, long-lasting antimalarial that could potentially be delivered as a single-dose cure.

Clinical Trials 52

Clinical Trials Treatment Trials Disease 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.

Regulations 40

Regulations Clinical Trials Production Trials 40

The Pharma Data

NOVEMBER 10, 2020

Innovent has established a robust pipeline of 23 valuable assets, including four launched products, four products in pivotal trials, and multiple prioritized assets such as CD47, PDL1/CD47, TIGIT, VEGF/complement protein etc. that are fast progressing clinical trials. TYVYT® is the only PD-1 inhibitor included in the NRDL.

Biosimilars 52

Biosimilars Clinical Trials International Clinical Development 52

Drug Target Review

OCTOBER 26, 2023

They can accelerate various aspects of drug research and development, providing novel opportunities for faster and more effective solutions to health challenges. Efficacy and safety of voretigene neparvovec (AAV2-hRPE65v2) in patients with RPE65-mediated inherited retinal dystrophy: a randomised, controlled, open-label, phase 3 trial.

Engineering 105

Engineering Virus Therapies Immune Response 105

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

Hospitals 52

Hospitals Treatment Trials Long-Term Care Facilities 52

Drug Target Review

SEPTEMBER 21, 2023

She spent one year as a research assistant, focusing on NTDs and one year as a teaching assistant, focusing on Pharmacology. She is currently a lab technician and research assistant at Hallmark Medicals, where she assists in the conducting of Assisted Reproductive Technologies (ARTs) and drug research.

Drugs 105

Drugs Treatment Disease Research 105

DrugBank

MARCH 22, 2024

These data sources are known for being highly referenced and usable for specific research activities; further yet, a number of recognizable open sources, along with their identifiers, are considered industry standard resources. Limited coverage : Open source ontologies and datasets have a very narrow and particular focus on what they cover.

Licensing 74

Licensing Licensing Research Production 74

Agency IQ

JUNE 7, 2024

The BIMO program includes eleven compliance programs , each covering a distinct area : “These compliance programs address inspections of nonclinical testing laboratories in accordance with Good Laboratory Practice (GLP), clinical investigators in accordance with Good Clinical Practice (GCP), sponsors/Contract Research Organizations (CROs)/clinical (..)

FDA 40

FDA Compliance Regulations Production 40

Agency IQ

JUNE 9, 2023

The problems: Although the current regulation stimulated orphan drug research, it didn’t do enough The regulation fostered development of medicines for rare diseases since implementation, but not enough. Additionally, the smaller potential customer base may provide an insufficient return on the investment into research.

Marketing 40

Marketing Regulations Biosimilars Drugs 40

Codon

JUNE 2, 2024

This discordance, or lack of “ predictive validity ” when translating results across organismal boundaries, is perhaps most harmful in the biomedical field; despite extensive testing in mouse models, only 10 percent of drugs that make it to clinical trials ever make it to market.

Laboratories 115

Laboratories Research Disease Science 115