Drug Discovery World

JULY 20, 2023

Pharmacokinetic and pharmacodynamic modelling in mice and allometric scaling should be used to refine dose strengths for human studies, and the available safety data may need re-evaluating considering predicted dosages. However, despite a known safety profile and mechanism of action, the failure rate of 30% is still high.

Clinical Pharmacology 100

Clinical Pharmacology Clinical Trials Drugs Trials 100

FDA Law Blog: Drug Discovery

FEBRUARY 2, 2023

For more on FDORA’s other provisions, see HPM’s complete summary here ). Since 1962, the FD&C Act has authorized FDA to require that sponsors of clinical trials submit data from “preclinical tests (including tests on animals)” in order to demonstrate that their drug is safe enough to advance to testing in humans. 42 U.S.C. §

Animal Testing 64

Animal Testing Biosimilars Cell Based Assays FDA 64

The Pharma Data

MAY 4, 2021

About OLUMIANT ® (baricitinib) OLUMIANT, a once-daily, oral JAK inhibitor was discovered by Incyte and licensed to Lilly. Lilly licensed etesevimab from Junshi Biosciences after it was jointly developed by Junshi Biosciences and the Institute of Microbiology , Chinese Academy of Science (IMCAS). It is approved in the U.S.

Therapies 52

Therapies Hospitals FDA Approval Long-Term Care Facilities 52

New Drug Approvals

SEPTEMBER 29, 2024

The pharmacokinetic profiles of COR388 in AD and controls were reported to be similar. In August 2022, Cortexyme discontinued the gingipain inhibitor program, and offered it for external licensing ( press release ). 2009 Mar;77(3):1246-61. Periodontitis has been linked epidemiologically to cognitive impairment, and P.

Small Molecule 62

Small Molecule DNA Disease Trials 62

Agency IQ

JULY 26, 2024

BY LAURA DIANGELO, MPH , RACHEL COE, MSC | JUL 23, 2024 9:54 PM CDT Biosimilarity and interchangeability: A quick recap The Biologics Price Competition and Innovation (BPCI) Act of 2009 intended to increase the number of biologic products on the market by creating two types of approvals for biosimilar products.

Biosimilars 40

Biosimilars Science FDA Licensing 40

The Pharma Data

MARCH 2, 2021

and Shionogi Limited as shareholders, today announced the presentation of 16 sponsored abstracts from its diverse portfolio of innovative pipeline and licensed HIV treatment and prevention options at the Conference on Retroviruses and Opportunistic Infections (CROI 2021), being held virtually 6-10 March. About ViiV Healthcare.

Treatment 52

Treatment Pharmacokinetics Licensing Licensing 52