Drug Discovery World

NOVEMBER 3, 2023

News round-up for 30 October – 3 November by DDW Editor Reece Armstrong My news highlights this week feature a variety of exciting clinical trial results and launches that are examining therapies for much-needed disease areas, new drug approvals and even a space mission with a pharma twist.

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Clinical Trials Drugs Trials Therapies 130

Drug Discovery World

MAY 21, 2024

In contrast, machine learning can facilitate epitope-specific design: directing the algorithm towards favourable epitopes that elicit favourable biological responses, which may improve the prospects for the antibody in drug trials. These targets, along with many others, are universally deemed as ‘difficult-to-drug’ targets.

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FDA Approval Disease FDA Treatment 147

Agency IQ

AUGUST 23, 2024

The office, which is responsible for directly reviewing and regulating medical devices and diagnostics, was established under a major restructuring of CDRH in 2018-2019 as part of CDRH’s “Total Product Lifecycle (TPLC)” approach. OPEQ is organized into eight “Offices of Health Technology” (OHTs), which are structured by therapeutic area (e.g.,

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Alta Sciences

JULY 31, 2024

How Improving Diversity Can Benefit Clinical Trials pmjackson Wed, 07/31/2024 - 19:19 In July 2024, the U.S. Food and Drug Administration (FDA) published a draft guidance to ensure greater diversity in clinical trials, which is expected to become a final guidance by June 2025.

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Clinical Trials Trials Clinical Pharmacology Pharmacokinetics 52

Drug Target Review

SEPTEMBER 19, 2023

puts an end to the previous mandate that all drugs need to be tested on animals prior to human clinical trials. This major shift to the orthodox tradition of using animal experiments in drug testing dates back the Aristotle’s time and cemented 80 years ago with initial federal mandate of drug safety regulation of 1938.

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Animal Testing Clinical Trials Pharmaceutical Companies FDA 98

Drug Target Review

OCTOBER 3, 2024

Aside from the advent of complex antibody-based drugs, the industry is facing some additional changes which are shaping drug development. 3 This change signals a major shift away from animal use in drug safety regulation and encourages the use of alternative methods like organ-on-chip or other animal-free technologies.

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Molecular Biology Pharmacokinetics Laboratories Animal Testing 52

Agency IQ

FEBRUARY 2, 2024

Diagnostics landscape analysis: Key issues and a look ahead at 2024 Diagnostic regulation in the U.S. Following significant policy proposals in recent years, 2024 is gearing up to be a profoundly impactful year for diagnostics developers and the policymakers who regulate them. is a constantly evolving topic. In the U.S.,

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