Drug Discovery World

AUGUST 21, 2023

It is currently under investigation in various other clinical trials, for example, as a treatment for polycystic ovary syndrome at the University of Hull, and to understand its impact on ageing at the University of Texas Health Science Center at San Antonio. The drugs are currently approved as treatments for type 2 diabetes and weight loss.

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Clinical Trials Trials Treatment Licensing 130

Drug Target Review

JULY 4, 2023

These therapies have broadened treatment options for patients to expand beyond the more traditional small molecule drug alternatives. ADCs have the potential to redress the poor balance between safety and efficacy seen with traditional cancer treatment options. 3D rendering of Antibody Drug Conjugate Molecules.

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Small Molecule Drugs Clinical Pharmacology Trials 145

Agency IQ

AUGUST 2, 2024

What We Expect the FDA to do in August and September 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. This is what OIRA is currently reviewing.

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Agency IQ

AUGUST 16, 2024

By Amanda Conti | Aug 13, 2024 10:00 PM CDT Regulatory context: Psychedelic regulation and drug development A growing body of evidence suggests that psychedelics may provide clinical benefit for certain purposes, especially mental health conditions. Sponsors should plan to justify the inclusion of a psychotherapy component.”

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The Pharma Data

DECEMBER 12, 2020

The medicine is approved in many countries for the treatment of patients with paroxysmal nocturnal haemoglobinuria (PNH), atypical haemolytic uremic syndrome, generalized myasthenia gravis and neuromyelitis optica spectrum disorder. Rare diseases is a high-growth therapy area with rapid innovation and significant unmet medical need.

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Regulations International Disease Small Molecule 75

Drug Discovery World

JULY 1, 2024

The Novo Nordisk Foundation Center for Genomic Mechanisms of Disease is an initiative which facilitates collaboration between the Broad Institute and Danish researchers that are investigating the genetics and gene regulation of common complex disease, including type 2 diabetes and obesity. billion DKK ($11.97

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Disease International Research Science 162

Agency IQ

JUNE 9, 2023

Just over a month ago, the European Commission released its proposal for the new pharmaceutical directive and regulation. BY KIRSTEN MESSMER, PHD, RAC JUN 5, 2023 10:14 PM CDT Regulatory Background: How things work now Regulation (EC) No 141/2000 (the Orphan Regulation) provides the legal framework for orphan drug designations and incentives.

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