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

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.

Clinical Trials 52

Clinical Trials Trials Hospitals Vaccine 52

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.

Engineering 105

Engineering Virus Therapies Immune Response 105

Drug Target Review

SEPTEMBER 21, 2023

Introduction I clearly remember an incident as a researcher, which kept happening, from my undergraduate research up till now. Summary of research The undergraduate study concentrated on the potential adulticidal effects of oral analgesics (acetaminophen, aspirin, and ibuprofen) on Onchocerca volvulus. doi: 10.1002/14651858.CD011146.pub2.

Drugs 105

Drugs Treatment Disease Research 105

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.

Clinical Trials 52

Clinical Trials Treatment Trials Disease 52

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.

Licensing 74

Licensing Licensing Research Production 74

The Pharma Data

NOVEMBER 10, 2020

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. 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

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

JANUARY 26, 2021

Lilly’s chief scientific officer and president of Lilly Research Laboratories. In the trial, the safety profile of bamlanivimab and etesevimab together was consistent with observations from other Phase 1, Phase 2 and Phase 3 trials evaluating these antibodies. INDIANAPOLIS, Jan. have reached record highs.

Hospitals 52

Hospitals Treatment Trials Long-Term Care Facilities 52

Agency IQ

JUNE 7, 2024

FDA’s new guidance explains what to do during a BIMO inspection Under the FDA’s Bioresearch Monitoring (BIMO) program, the agency oversees the operation of regulated research. In short, the BIMO program oversees regulated research – both human and animal – in a variety of ways.

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

It took another five years for a pair of American researchers to come up with an explanation before going on to pioneer the mouse as biomedicine’s premier model organism. It took another century after Mendel’s pea experiments for the mouse to become an established presence in research labs.

Laboratories 115

Laboratories Research Disease Science 115