The Anticancer Fund

JUNE 7, 2022

10 June 2022 Language EN Drug repurposing is a strategy for identifying new uses for approved drugs, outside the scope of the original indication. Below, we have listed recent findings about the repurposing of generic drugs in oncology. It is one of the focus areas of the Anticancer Fund.

Clinical Trials 40

Clinical Trials Drugs Trials Treatment 40

Agency IQ

DECEMBER 1, 2023

FDA updates guidance on developing drugs for Covid-19, replacing pandemic-era version Last week, FDA published the third update to its guidance on the development of products to prevent or treat Covid-19. Lastly, the revised guidance briefly discussed trials meant to assess drugs intended for prevention of Covid-19.

FDA 40

FDA Clinical Trials Vaccine Trials 40

New Drug Approvals

SEPTEMBER 13, 2024

2] As of July 2022, it is in phase 3 clinical trials for major depressive disorder. [2] 2] Like other kappa opioid antagonists currently under clinical investigation for the treatment of major depression, its efficacy may be compromised by the countervailing activation of pro-inflammatory cytokines in microglia within the CNS. [7]

Treatment 62

Treatment Clinical Trials Pharmacokinetics Pharmaceuticals 62

Agency IQ

FEBRUARY 23, 2024

Workshop addresses oncology dose optimization across full span of development In a series of broad-ranging, frank discussions, attendees at a joint FDA-American Association of Cancer Research (AACR) workshop worked through opportunities and challenges for dose optimization across the span of cancer drug development activities.

Science 40

Science FDA Trials Clinical Pharmacology 40

Agency IQ

DECEMBER 11, 2023

By our count, the FDA’s Oncologic Drugs Advisory Committee held seven meetings in 2023; additionally, the Oncology Center of Excellence authored nine new (draft) and six final guidance documents. A key fact about the dostarlimab phase 2 trial for LARC: The drug was stunningly effective. months, according to the GSK presentation.

FDA 40

FDA Science Clinical Trials Trials 40

The Pharma Data

FEBRUARY 8, 2021

Food and Drug Administration (FDA) approval for nmCRPC on February 14, 2018 and was approved for mCSPC on September 17, 2019. Thyroid replacement therapy, when clinically indicated, should be initiated or dose-adjusted. DRUG INTERACTIONS. Drug Interactions – Based on in vitro data, ZYTIGA ® is a substrate of CYP3A4.

Pharmaceutical Companies 52

Pharmaceutical Companies Treatment Clinical Trials Therapies 52

Agency IQ

SEPTEMBER 15, 2023

FDA’s nonprescription advisors find no efficacy for phenylephrine This week, FDA’s Nonprescription Drugs Advisory Committee (NDAC) voted unanimously that current scientific data do not support the efficacy of oral phenylephrine as a nasal decongestant, aligning with FDA analysis — and re-analysis — of data.

Science 40

Science FDA Clinical Trials Clinical Pharmacology 40

Agency IQ

FEBRUARY 12, 2024

A closer look at CDER’s new 2024 guidance agenda The FDA’s Center for Drug Evaluation and Research, its drug review division, this week quietly updated its 2024 Guidance Agenda, a list of all draft guidance documents the agency is working on this calendar year.

Biosimilars 40

Biosimilars Science Clinical Pharmacology FDA 40

Alta Sciences

OCTOBER 30, 2023

Podcast : FDA Guidance for Industry Psychedelic Drugs Extensively studied for potential therapeutic efficacy, psychedelic drug development comes with its own set of clinical development requirements. Watch the video. Read the blog. TOP MANUFACTURING AND ANALYTICAL RESOURCES The Altascientist : Issue No. Listen here.

Science 52

Science Clinical Trials Pharmacokinetics Pharmacy 52

Agency IQ

FEBRUARY 15, 2024

Priority A List.

FDA 40

FDA Science Biosimilars Clinical Trials 40

Alta Sciences

JULY 31, 2024

How Improving Diversity Can Benefit Clinical Trials pmjackson Wed, 07/31/2024 - 19:19 In July 2024, the U.S. Food and Drug Administration (FDA) published a draft guidance to ensure greater diversity in clinical trials, which is expected to become a final guidance by June 2025.

Clinical Trials 52

Clinical Trials Trials Clinical Pharmacology Pharmacokinetics 52