Drug Discovery World

MAY 9, 2023

Jantzen Sperry , PhD, Director of Scientific Operations at Certis Oncology looks at how the adoption of orthotopic PDX models can elevate the impact of cancer research and improve translation in oncology drug development. Fewer than 5% of oncology drugs that enter clinical trials in the US receive US FDA approval.

Drug Development 130

Drug Development Clinical Trials Animal Testing Cell Based Assays 130

FDA Law Blog: Drug Discovery

FEBRUARY 2, 2023

While this hype may be warranted in some respects—a 60-year old legal provision has now been amended to acknowledge that the science of drug development is advancing—the change is mostly symbolic and is likely to take many years before we see it have a measurable impact. FDORA § 3209(a)(2).

Animal Testing 64

Animal Testing Biosimilars Cell Based Assays FDA 64

Drug Target Review

JULY 6, 2023

Animal testing plays a significant role in pre-clinical research and therefore requires the use of millions of animals. million scientific procedures involving live animals were carried out in 2020. million scientific procedures involving live animals were carried out in 2020. In Britain, 2.88 In Britain, 2.88

Animal Testing 105

Animal Testing Drugs Clinical Trials Clinical Research 105

Drug Discovery World

FEBRUARY 2, 2023

As of late December 2022, the US Food and Drug Administration (FDA) no longer needs drugs to be tested in animals to receive approval, according to legislation signed by President Joe Biden 1 – the Modernization Act 2.0. may not materially change the current drug approval process at the FDA.

Animal Testing 130

Animal Testing FDA Clinical Trials Drugs 130

Drug Discovery World

APRIL 12, 2023

The legislation means that drug developers will now have further options to investigate the safety and efficacy of their products under investigation. Animal testing, whilst serving an important purpose for drug development has long been regarded as a contentious issue by both animal rights activists and scientists themselves.

FDA 130

FDA Animal Testing Cell Based Assays Clinical Trials 130