Alta Sciences

APRIL 17, 2024

Five Promising Treatment Areas in Early-Phase Drug Development in 2024 aasimakopoulos Wed, 04/17/2024 - 15:52 Early-phase drug development is an ever-changing landscape, as emerging science leads to new promising areas of research for the treatment of human health issues.

Drug Development 52

Drug Development Treatment FDA Approval Drugs 52

Agency IQ

AUGUST 16, 2024

By Amanda Conti | Aug 13, 2024 10:00 PM CDT Regulatory context: Psychedelic regulation and drug development A growing body of evidence suggests that psychedelics may provide clinical benefit for certain purposes, especially mental health conditions. The road to research on psychedelic products is paved with obstacles.

FDA 40

FDA Trials Regulations Therapies 40

Alta Sciences

AUGUST 12, 2024

Metabolic Drug Development: A to Z Solutions blussier Mon, 08/12/2024 - 18:07 HTML In the complex and dynamic field of metabolic drug development, partnering with an accomplished contract research organization is essential. We support data management both at our clinics and at external sites.

Drug Development 40

Drug Development Clinical Trials Pharmacokinetics Drugs 40

Agency IQ

DECEMBER 1, 2023

Now, the FDA has issued its first post-PHE version of this guidance Although the previous version of the guidance was revised to remain in effect until March 7, 2024, it has now been replaced. drug-drug interactions) and intrinsic factors (e.g.,

FDA 40

FDA Clinical Trials Vaccine Trials 40

Agency IQ

MAY 17, 2024

Under GDUFA III, the scope and purpose of pre-submission meetings for generic drug developers has changed. During a meeting this week, FDA speakers highlighted the uniqueness of this redesigned meeting type in allowing sponsors to explain how they’ve addressed challenges encountered during product development.

Science 40

Science FDA Production Drugs 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Evaluation and Research, its drug review division, this week quietly updated its 2024 Guidance Agenda, a list of all draft guidance documents the agency is working on this calendar year. What’s new?

Biosimilars 40

Biosimilars Science Clinical Pharmacology FDA 40

Agency IQ

FEBRUARY 15, 2024

166 guidance documents the FDA is actively working on in 2024 (and beyond) The FDA is set to be very, very busy in 2024. We’ve identified a total of 166 guidance documents that are under active development, and have the key details for you below.

FDA 40

FDA Science Biosimilars Production 40

Alta Sciences

AUGUST 28, 2023

s novel, proprietary cytoprotective drug candidate, CMX-2043, for the treatment of acute TBI. The Phase I trial was performed to evaluate safety, tolerability, and pharmacokinetics in a group of 80 healthy participants in a two-part, double-blind, placebo-controlled study. To learn more about Altasciences, visit altasciences.com.

Trials 40

Trials Treatment Clinical Pharmacology Pharmacokinetics 40

New Drug Approvals

SEPTEMBER 13, 2024

4] [6] Aticaprant was originally developed by Eli Lilly , was under development by Cerecor for a time, and is now under development by Janssen Pharmaceuticals. [2] 12] Positron emission tomography imaging revealed that brain KORs were almost completely saturated by the drug 2.5 2] Aticaprant is taken by mouth. [1]

Treatment 62

Treatment Pharmacokinetics Clinical Trials Pharmaceuticals 62

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

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

AUGUST 16, 2024

By Rachel Coe, MSC | Aug 12, 2024 6:15 PM CDT Background For decades, sponsors have turned to maximum tolerated dose (MTD) as the primary method for dose selection in oncology. In early-stage development of traditional cytotoxic oncology drugs (i.e., To be [administered with] food or not to be?

Production 40

Production FDA Science Clinical Trials 40

FDA Law Blog: Drug Discovery

JULY 9, 2024

The deadline for the Draft Guidance was December 29, 2023, so the draft, issued on June 26, 2024, is about 6 months late under FDORA’s mandate. FDA encourages sponsors to consult patients and healthcare providers to assist in developing such strategies. providing language assistance); Reducing participant burden (e.g.,

FDA 59

FDA Clinical Trials Disease Trials 59

Agency IQ

FEBRUARY 23, 2024

Overdue EMA reflection paper on drug dosing in obesity introduces more questions than answers Although the prevalence of overweight and obesity in Europe exceeds 50%, the EMA does not currently offer guidance to sponsors on investigating the effects of obesity during drug development.

Drugs 40

Drugs Clinical Trials Pharmacokinetics Drug Development 40

Agency IQ

FEBRUARY 2, 2024

The revisions flesh out considerations for use of biomarkers at all stages of product development and add new content on rare cancers and platform trial designs. BY KIRSTEN MESSMER, PHD, RAC, KARI OAKES | JAN 31, 2024 9:01 PM CST Regulatory Background Cancer is the second leading cause of death in the E.U. were from cancer.

Clinical Trials 40

Clinical Trials Trials Treatment Production 40

Agency IQ

DECEMBER 11, 2023

In 2015, the FDA, along with the American Association for Cancer Research (AACR), held a workshop on dose optimization for small molecules. Friends of Cancer Research (FOCR) has also been working to improve tolerability and dose optimization programs in collaboration with various stakeholders. months, according to the GSK presentation.

FDA 40

FDA Science Clinical Trials Trials 40

Agency IQ

JUNE 28, 2024

The overhauled guidance, which was entirely re-written after FDA obtained new authority from Congress in 2022, offers granular recommendations on how sponsors of both drug and device programs should interpret compliance with the new legal requirements, and also answers questions about how FDA intends to waive certain requirements.

FDA 40

FDA Science Clinical Trials Production 40