2023, Clinical Research, Pharmacokinetics and Research

What recent paediatric guidelines mean for drug developers

Drug Discovery World

JULY 25, 2023

These guidelines facilitate open communication between regulators and researchers, enabling the industry to adapt and conduct more robust and efficient paediatric clinical studies, while avoiding unnecessary trials.

Drug Development

Drug Development Clinical Pharmacology Pharmacokinetics Drugs

Where is the promise for plant-based medicines? Part 1: Cannabis

Drug Discovery World

AUGUST 3, 2023

With this in mind, the FDA claims to be committed to sound scientific research into the area and has a number of processes in place for those in the medical research community who intend to study cannabis 1. He said: “But for this market to become a reality, we need much more research into cannabis products and potential indications.

Clinical Trials

Clinical Trials Regulations Production FDA

Four Pain Models Altasciences Uses to Assess Treatments During Clinical Trials

Alta Sciences

SEPTEMBER 13, 2023

Four Pain Models Altasciences Uses to Assess Treatments During Clinical Trials pmjackson Wed, 09/13/2023 - 17:01 September is pain awareness month, and the importance of pain management and continued research into effective analgesics is integral to helping patients suffering from various pain conditions.

Clinical Trials

Clinical Trials Treatment Trials Drug Development

Targeting the immunotherapy potential of cytokines IL-12 and IL-18 with new advancements in protein engineering

Drug Target Review

JUNE 6, 2023

Difficult-to-treat and rare, complicated cancers remain a perplexing challenge for IO researchers. Research has shown that these immune system proteins have the ability to trigger anti-cancer immune pathways. Currently he is Alkermes’ Oncology Fellow and Head of a Oncology Preclinical Research at the company.

Engineering

Engineering Immune Response Biochemical Pharmacology Clinical Trials

What Does a CRO Actually Do?

Vial

MARCH 15, 2024

A contract research organizations (CROs) is a third-party firm contracted by sponsors to deliver specialized services aimed at optimizing their research. This article explores the roles of CROs and highlights strategic partnerships between CROs and external vendors, designed to enhance research outcomes.

Clinical Trials

Clinical Trials Compliance Trials Laboratories

Biochemical assays and deep cyclic inhibition in cancer treatment

Drug Target Review

JULY 12, 2023

Many cell lines used in pancreatic cancer research, for example, are generally not genetically aligned with most patients in the clinic. If researchers continue to use an intuitive approach of chronically suppressing the MAPK pathway, we will likely continue to see the same results in patients with little improvement.

Biochemical Assays

Biochemical Assays Treatment Bioinformatics Disease

Article FDA Thank You The FDA rejected a psychedelic sponsor’s bid for approval. Here are six industry takeaways

Agency IQ

AUGUST 16, 2024

The road to research on psychedelic products is paved with obstacles. This means that research programs are subject to additional oversight from U.S. FDA released a draft guidance in June 2023 attempting to address many of these unique aspects of clinical research on psychedelic substances.

FDA

FDA Trials Regulations Therapies

Article FDA Thank You FDA looking to beef up its remote assessments with artificial intelligence

Agency IQ

AUGUST 11, 2023

BY AMANDA CONTI, LAURA DIANGELO, MPH AUG 9, 2023 7:35 PM CDT A new contract notice seeks software support to leverage AI-based data extraction technology. These inspections are used by FDA to assess sites involved in clinical research, and involve activities such as inspections, data audits and more.

FDA

FDA Compliance Clinical Trials Pharmacokinetics

News from AACR 2024: Wednesday’s highlights

Drug Discovery World

APRIL 11, 2024

The Program Committee Chairs commented: “It has been an educational, enlightening, and inspiring week of captivating cancer science and research. Research highlights Blacksmith Medicines announced preclinical data on its oncology programme targeting flap endonuclease 1 (FEN1). And thanks to the city of San Diego for its hospitality.”

Biochemical Assays

Biochemical Assays DNA Science Pharmacokinetics

Article FDA Thank You FDA offers a status check on its diversity in research provisions, one year post-FDORA

Agency IQ

DECEMBER 11, 2023

FDA offers a status check on its diversity in research provisions, one year post-FDORA At a workshop on FDA’s implementation of new statutory requirements for diversity in clinical research, agency and industry representatives gave a status update on implementation.

FDA

FDA Research Clinical Trials Regulations

Altasciences Completes Successful Phase I Trial of Ischemix’ Novel Compound for Treatment of Traumatic Brain Injury (TBI)

Alta Sciences

AUGUST 28, 2023

Altasciences Completes Successful Phase I Trial of Ischemix’ Novel Compound for Treatment of Traumatic Brain Injury (TBI) pmjackson Mon, 08/28/2023 - 14:04 Laval, Québec, August 30, 2023 – Altasciences is pleased to have completed a Phase I trial on Ischemix, Inc.’s We are proud to support Ischemix in advancing this vital new therapy.”

Trials

Trials Treatment Clinical Pharmacology Pharmacokinetics

What are the top disease areas for clinical drug trials?

Drug Discovery World

FEBRUARY 20, 2023

An ongoing Phase I clinical trial will assess the safety and pharmacokinetics of AVA6000, which has potential in a range of cancer types. In the same month, DynamiCure launched its Phase I clinical trial evaluating anti-CD93 monoclonal antibody candidate, DCBY02, in adults with a wide range of advanced cancers.

Trials

Trials Drug Trials Disease Clinical Trials

Can Your CRO Add Value During a Recession?

PPD

JUNE 20, 2023

Biotech and biopharma companies with a dependable contract research organization (CRO) partner will derive strong value across all business cycles — ensuring project delivery excellence and continued speed to market. Check out our industry predictions for 2023 to see our thinking on what’s ahead.

Clinical Trials

Clinical Trials Drug Development Trials Biosimilars

Analysis Life Sciences Thank You FDA’s Diversity Action Plan: Questions, answers, and what we (don’t) know so far

Agency IQ

AUGUST 9, 2024

By Laura DiAngelo, MPH | Aug 2, 2024 6:30 PM CDT A refresher on FDA’s Diversity Action Plan (DAP) guidance: In April 2022, the FDA issued a draft guidance document on diversity in clinical research programs. Read AgencyIQ’s extensive analysis of the draft guidance here.] Read AgencyIQ’s extensive analysis of the draft guidance here.]

Science

Science FDA Production Trials

Better Late Than Never – Unpacking FDA’s Highly Anticipated (and Long Overdue) Draft Guidance on Diversity Action Plans

FDA Law Blog: Drug Discovery

JULY 9, 2024

FDA issued its draft guidance titled “ Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies ,” (the “Draft Guidance”) which replaces the previous pre-FDORA April 2022 draft guidance of the same name. providing language assistance); Reducing participant burden (e.g.,

FDA

FDA Clinical Trials Disease Trials

Article EMA Thank You EMA finalizes clinical anticancer therapeutic guidance update

Agency IQ

FEBRUARY 2, 2024

The European Commission also implemented its Mission on Cancer , which aims to further cancer research and innovation through funding in the same areas as the cancer plan. The EMA started providing guidance on the clinical development of anticancer therapeutics in 1996.

Clinical Trials

Clinical Trials Trials Treatment Production

Analysis Life Sciences Thank You FDA just published its Diversity Action Plan guidance. Here’s what you need to know.

Agency IQ

JUNE 28, 2024

BY LAURA DIANGELO, MPH | JUN 26, 2024 8:17 PM CDT Quick background: FDA’s work to advance clinical trial diversity through prospective planning The FDA has longstanding policy interests focused on research study diversity. See AgencyIQ’s analysis for more detailed history of FDA’s policy and guidance on diversity in research studies ].

FDA

FDA Science Clinical Trials Production

Drug Discovery Digest

What recent paediatric guidelines mean for drug developers

Where is the promise for plant-based medicines? Part 1: Cannabis

Trending Sources

Four Pain Models Altasciences Uses to Assess Treatments During Clinical Trials

Targeting the immunotherapy potential of cytokines IL-12 and IL-18 with new advancements in protein engineering

What Does a CRO Actually Do?

Biochemical assays and deep cyclic inhibition in cancer treatment

Article FDA Thank You The FDA rejected a psychedelic sponsor’s bid for approval. Here are six industry takeaways

Article FDA Thank You FDA looking to beef up its remote assessments with artificial intelligence

News from AACR 2024: Wednesday’s highlights

Article FDA Thank You FDA offers a status check on its diversity in research provisions, one year post-FDORA

Altasciences Completes Successful Phase I Trial of Ischemix’ Novel Compound for Treatment of Traumatic Brain Injury (TBI)

What are the top disease areas for clinical drug trials?

Can Your CRO Add Value During a Recession?

Analysis Life Sciences Thank You FDA’s Diversity Action Plan: Questions, answers, and what we (don’t) know so far

Better Late Than Never – Unpacking FDA’s Highly Anticipated (and Long Overdue) Draft Guidance on Diversity Action Plans

Article EMA Thank You EMA finalizes clinical anticancer therapeutic guidance update

Analysis Life Sciences Thank You FDA just published its Diversity Action Plan guidance. Here’s what you need to know.

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