Advarra

AUGUST 16, 2022

In 2016, the FDA granted 333 (57%) of the 582 orphan drug designation requests it received – nearly 10 times the number of designations the agency awarded in 1986. The agency’s 2019 guidance, Rare Diseases: Common Issues in Drug Development , called attention to the need for natural history studies for rare diseases.

Disease 52

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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

Drug Target Review

SEPTEMBER 19, 2023

In addition, these models at the current state are better for short term tests, over a week or two and cannot be used for acquiring data from long term drug exposures. Miniature organs as test beds for new drugs Organoids are miniature human organs with clusters of cells derived from stem cells and mimic specific tissues.

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Animal Testing Clinical Trials Pharmaceutical Companies FDA 98

PPD

MARCH 28, 2024

In a recent survey of more than 150 global drug development leaders, nearly one in three (30%) cited maximizing asset value/ROI as a top challenge facing their organization — the third-highest reported challenge facing drug developers. PPD Biotech solutions: Your partner for better delivery and capital efficiency.

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Trials Clinical Trials Drug Development Clinical Research 52

Advarra

JUNE 27, 2023

The Importance of Clinical Research in Medical Advancements Researchers use clinical trials to test a drug’s or other medical treatment’s safety and efficacy. Most modern medicines were developed from clinical trials , and clinical trials remain essential for drug development.

Clinical Research 52

Clinical Research Research Clinical Trials Trials 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.

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FDA Laboratories Regulations Clinical Trials 40

Conversations in Drug Development Trends

NOVEMBER 3, 2022

Looking to diversify the reach of your orphan drug trial? Reach out to learn how Worldwide Clinical Trials can help. The post What the FDA’s guidance on diversity means for rare disease sponsors appeared first on Worldwide Clinical Trials. Originally published in BioPharma Dive on October 31st, 2022.

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Disease Clinical Trials Trials International 52