Agency IQ

AUGUST 16, 2024

This study is planned to start in late 2024 and conclude in late 2025. Lykos also registered an additional open-label Phase 1 pharmacokinetics study of midomafetamine and metabolites in patients with moderate hepatic impairment to understand if a dose adjustment is necessary in that population.

FDA 40

FDA Trials Regulations Therapies 40

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

BPL-003, a patented intranasal benzoate formulation of 5-MeO-DMT, has thus far demonstrated good tolerability and favourable pharmacokinetics in an ongoing randomised, single ascending dose Phase I study. . Discontinuation of evaluating oral psilocybin for the treatment of SUNHA .

Clinical Trials 130

Clinical Trials Pharmacokinetics Science Therapies 130

Drug Target Review

JULY 1, 2024

The global pain management market is projected to reach about $87 billion by 2025, driven by rising chronic diseases, an ageing population and more surgical procedures. SRP-001 is a novel non-opioid pain relief candidate that works centrally in the brain, offering robust pharmacokinetics without the adverse effects of current medications.

Treatment 59

Treatment Clinical Trials Molecular Biology Therapies 59

Alta Sciences

JULY 31, 2024

Food and Drug Administration (FDA) published a draft guidance to ensure greater diversity in clinical trials, which is expected to become a final guidance by June 2025.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

Clinical Trials 52

Clinical Trials Trials Clinical Pharmacology Pharmacokinetics 52

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?

Science 40

Science FDA Production Trials 40

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.

Vaccine 52

Vaccine Therapies Trials Clinical Trials 52

Agency IQ

FEBRUARY 15, 2024

CDER, CBER Draft 12/29/2025 FDA must issue final guidance no later than 18 months after the close of the public comment period for draft guidance. use of RWE, registries) for capturing post-approval safety and efficacy data for cell and gene therapy products.

FDA 40

FDA Science Biosimilars Production 40

FDA Law Blog: Drug Discovery

JULY 9, 2024

This could be based on differential pharmacokinetics (“PK”) or pharmacodynamics (“PD”), possible differences in susceptibility to specific adverse events of concern, or due to differential presentation of the disease or condition.

FDA 59

FDA Clinical Trials Disease Trials 59

Agency IQ

JULY 26, 2024

In its Fiscal Year 2025 budget proposal , the FDA requested that Congress “eliminate the statutory distinction between the approval standard for biosimilar and interchangeable biosimilar products” and “deem all approved biosimilars to be interchangeable with their respective reference products.”

Biosimilars 40

Biosimilars Science FDA Licensing 40

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. Independently optimized receptor bias and potency as well as pharmacokinetics to create a potentially best-in-class IL-2 product. .

Clinical Trials 40

Clinical Trials Small Molecule Clinical Development Trials 40

Agency IQ

JUNE 28, 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.

FDA 40

FDA Science Clinical Trials Production 40