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Trials pmjackson Wed, 07/31/2024 - 19:19 In July 2024, the U.S. Food and Drug Administration (FDA) published a draft guidance to ensure greater diversity in clinical trials, which is expected to become a final guidance by June 2025.

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Drug Discovery World

APRIL 11, 2024

It was announced that the next AACR Annual Meeting will take place in Chicago on 25-30 April 2025. The company reported that OBI-992 demonstrates remarkable antitumor efficacy, improved pharmacokinetic characteristics, and a favourable safety profile in animal models.

Biochemical Assays 130

Biochemical Assays DNA Science Pharmacokinetics 130

Drug Discovery World

OCTOBER 25, 2022

The acquisition adds ELE-101, a next-generation, short-duration psychedelic ready for Phase I clinical trials, to Beckley Psytech’s pipeline. . With a cash runway for operations extending into 2025, this acquisition reinforces Beckley Psytech’s position as a market leader in the development of psychedelic therapies.” .

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Clinical Trials Pharmacokinetics Science Therapies 130

New Drug Approvals

SEPTEMBER 13, 2024

2] [3] [4] A regulatory application for approval of the medication is expected to be submitted by 2025. [2] 2] As of July 2022, it is in phase 3 clinical trials for major depressive disorder. [2] hours following a single dose of 10 mg, which supported the 4 mg to 25 mg dosages that aticaprant is being explored at in clinical trials. [13]

Treatment 57

Treatment Pharmacokinetics Clinical Trials Pharmaceuticals 57

Drug Target Review

JULY 1, 2024

Overall, SRP-001’s modulation of pain signalling genes and pathways through endocannabinoid enhancement and FAAH inhibition supports its potential as an effective non-opioid pain therapeutic, validating the planned clinical trials. It addresses both acute and chronic pain, avoiding the addiction risks associated with opioids.

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Treatment Clinical Trials Molecular Biology Therapies 59

Agency IQ

AUGUST 9, 2024

estimated prevalence of the condition of interest, any relevant pharmacokinetic or pharmacogenomic data, demographic factors) and how they intend to meet those goals, as well as operational and process factors such as how they should be submitted and how the “action plan” may be updated over time. When would the guidance go into effect?

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The Pharma Data

SEPTEMBER 15, 2020

27 key programs highlighted, including assets that could potentially contribute revenue by 2025 and others in the 2026-2028 time frame. Major revenue contributions through 2025 anticipated from Oncology, Vaccines, Rare Disease and Inflammation and Immunology. Protease Inhibitor Program.

Vaccine 52

Vaccine Therapies Trials Clinical Trials 52

Agency IQ

FEBRUARY 15, 2024

These topics include administrative, advanced manufacturing, the Animal Rule, antimicrobials, biosimilars, blood products, breakthrough devices, cell and gene therapy products, CGMP, clinical pharmacology, clinical trials, clinical/medical guidance, combination products, communication, compounding, cybersecurity, device software, digital health technologies, (..)

FDA 40

FDA Science Biosimilars Production 40

FDA Law Blog: Drug Discovery

JULY 9, 2024

We’ve blogged about some of FDA’s efforts to increase diversity in clinical trials previously, and the Draft Guidance itself describes a variety of these efforts. DAPs for clinical trials are not new inventions, as previously mentioned; however, the new mandates under FDORA are designed to shift these plans from “should” to “must.”

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FDA Clinical Trials Disease Trials 59

The Pharma Data

JANUARY 10, 2021

In 2019, we introduced Vision 3×3, the company’s strategic roadmap through 2025, to build a leading biopharma company by achieving sustainable growth through multiple approaches. COPENHAGEN, Denmark, Jan. Morgan Healthcare Conference. “In . ?. . . .

Clinical Trials 40

Clinical Trials Clinical Development Small Molecule Trials 40

Agency IQ

JULY 26, 2024

In switching studies , a two-arm trial design is commonly employed. However, the “extent” of the data (comparability, CAA) will depend on the risk assessment of differences – and, in “some cases,” additional data like pharmacokinetic studies might be needed.

Biosimilars 40

Biosimilars Science FDA Licensing 40

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. That said, FDA has not done nothing in 2024 related to clinical trial diversity.

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