Drug Discovery World

FEBRUARY 20, 2023

The approval was based on results from the PROpel Phase III trial, however, the drug was rejected by UK regulator NICE because it requires expensive genetic testing. The post What are the top disease areas for clinical drug trials? appeared first on Drug Discovery World (DDW).

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Advarra

MARCH 21, 2023

Regulations for research involving devices, in vitro diagnostics (IVDs), and digital therapeutics differ from those governing pharmaceutical development. Interpreting evolving regulations for these devices is often a unique challenge for emerging biotech companies. In other words, what are the risks and benefits of the product?

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Agency IQ

MAY 3, 2024

What we expect European regulators to do in May 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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The Pharma Data

AUGUST 16, 2020

The Medical School Council (led by the heads of UK medical schools) and the regulator, the General Medical Council, say they are putting plans in place to improve the situation. Hundreds of other UK medical students have signed petitions demanding teaching that better reflects the diversity of the country. Life-or-death signs.

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Agency IQ

AUGUST 18, 2023

A deep dive into MDR and IVDR implementation: Where we are and where we’re going Late last summer, AgencyIQ took a close look at how the European Commission had been meeting its goals in implementing the medical device and IVD regulations (MDR and IVDR, respectively). regulators. reference laboratories. reference laboratories.

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Codon

JANUARY 21, 2024

The European Medicines Agency (EMA) is similar in this regard, although interestingly, that’s not the case in the United Kingdom, where regulators are not so directly involved in assessing a challenge study beforehand. There have been deaths in phase 1 medical and drug research among healthy participants.

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Drug Target Review

SEPTEMBER 19, 2023

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. Nature Cancer. 2022;3(4):418-36. Passini E, Britton OJ, Lu HR, Rohrbacher J, Hermans AN, Gallacher DJ, et al.

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Alta Sciences

JULY 31, 2024

Discover how drug developers, researchers, and regulators are ensuring this happens. Tags Clinical Trials Weight 15 Image Thumbnail_diversity in clinical trials_VAbutton.jpg Synopsis Representation and inclusion of various minority groups is crucial for medical research.

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Codon

MARCH 14, 2023

” About 6% of all mouse genes are regulated in sex-specific ways. The FDA used to require animal tests before a human drug trial could proceed; they reversed that decision in January. .” Other scientists have said much the same thing since at least 2018. A third experiment found no effect.

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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., In the E.U.,

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The Pharma Data

MAY 17, 2021

Regeneron resumes enrollment in lymphoma drug trials ( Reuters ). Incyte’s vitiligo treatment meets main goal in late-stage trial ( Reuters ). EU Medical Device Regulation May Spur Litigation Uptick ( Law360 ). Trump tax law cut what US drugmakers owed. BioPharmaDive ).

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