The Pharma Data

OCTOBER 1, 2021

The research, which spans clinical, health economics and outcomes research, translational, clinical pharmacology and preclinical presentations, highlights the breadth and depth of the company’s data on deucravacitinib, a first-in-class, oral, selective tyrosine kinase 2 (TYK2) inhibitor, also because the emerging dermatology pipeline.

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Agency IQ

FEBRUARY 2, 2024

But there are some potential hints, such as an upcoming Friends of Cancer Research event at which several of FDA’s top officials will be speaking on the “implementation of diversity plans.” Califf Robert Califf February 15 Friends of Cancer Research Enhancing Diversity in Clinical Trials: Implementation of Diversity Plans Namandjé N.

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Agency IQ

MARCH 1, 2024

Start Date End Date Event Event Type Center 02/26/2024 02/26/2024 FDA/CDER and American Association of Pharmaceutical Scientists (AAPS) Hybrid Public Workshop Public CDER 02/27/2024 02/27/2024 FDA Oncology Center of Excellence Presents: Conversations on Cancer, Black History Month Program: “Real Talk: Our Stories as Black Oncologists at the FDA” Webcast (..)

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The Premier Consulting Blog

JUNE 18, 2023

A Modern Twist for the Gold Standard of Clinical Research The gold standard for clinical research intended for regulatory approval is the randomized controlled trial that compares an investigational drug candidate to either a placebo, active control, or standard of care (SoC).

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Alta Sciences

AUGUST 28, 2023

We wish the team at Ischemix continued success on the next Phase of clinical research.” That is incredibly rewarding,” stated Dr. Morelli, MD, Chief Medical Officer and Principal Investigator for Altasciences. “We Altasciences helps sponsors get better drugs to the people who need them, faster.

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Alta Sciences

JULY 31, 2024

Regulatory organizations like Health Canada, the International Council for Harmonisation (ICH), and the European Medicines Agency (EMA) have long emphasized the importance of including diverse populations in clinical research. Discover how drug developers, researchers, and regulators are ensuring this happens.

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The Anticancer Fund

JUNE 7, 2022

Our intention is to help bring these findings to the attention of the broader cancer research community. All articles need to be critically assessed and viewed in their broader research context. Please get in touch if you’re interested in discussing research based on the findings presented below ( info@anticancerfund.org ).

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Agency IQ

OCTOBER 27, 2023

12/29/2023 FDORA, Section 3602 Clinical Trials Modernization : FDA is directed to require the submission of a “diversity action plan” for all Phase 3 clinical trials of new drugs. ” The report will also cover Federal agency roles in addressing vulnerabilities and statutory limitations.

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