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

PPD

MARCH 28, 2024

One of the fundamental pillars of this efficiency is a well-thought-out trial design. By carefully planning the trial structure, including the selection of endpoints and the overall methodology, companies reduce the likelihood of costly delays or the need for additional trial arms.

Trials 52

Trials Clinical Trials Drug Development Clinical Research 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.

Animal Testing 98

Animal Testing Clinical Trials Pharmaceutical Companies FDA 98

Advarra

JUNE 27, 2023

Clinical trials are studies involving human volunteers to research ways to prevent, detect, and treat various medical conditions. The goal is to identify safer, more effective methods of treating illnesses using new drugs or new combinations of existing drugs.

Clinical Research 52

Clinical Research Research Clinical Trials Trials 52

Conversations in Drug Development Trends

NOVEMBER 3, 2022

In April 2022, the Food and Drug Administration (FDA) issued draft guidance on developing a “Race and Ethnicity Diversity Plan” for clinical trials. In turn, the FDA’s guidance recognized the difficulty in recruiting for rare diseases and encouraged sponsors to become more resourceful and intentional about trial enrollment.

Disease 52

Disease Clinical Trials Trials International 52

Drug Target Review

OCTOBER 3, 2024

In 2024 alone, almost 50 antibody drug candidates are anticipated to enter regulatory review, the majority of which are mAbs. Aside from the advent of complex antibody-based drugs, the industry is facing some additional changes which are shaping drug development. 1975 Aug;256(5517):495–7. Antibodies to watch in 2024.

Molecular Biology 52

Molecular Biology Pharmacokinetics Laboratories Animal Testing 52

Agency IQ

AUGUST 23, 2024

The rule has significant implications for the way that LDTs are regulated in general, but also has additional impact on the use of LDTs in the context of drug development (i.e., There are several high-level takeaways from these updates for drug developers.

FDA 40

FDA Laboratories Regulations Clinical Trials 40