Agency IQ

APRIL 12, 2024

Additionally, reform package included revisions of the regulations for pediatric medicines and orphan drugs. Heated debates on the most contentious issues resulted in a compromise text for each legislation in March The proposal package , consisting of one directive and one regulation, was finally released in April 2023. citizens; 2.

Pharmaceuticals 40

Pharmaceuticals Regulations Packaging Marketing 40

Agency IQ

MARCH 7, 2024

BY LAURA DIANGELO, MPH | MAR 6, 2024 5:54 PM CST Fiscal year 2024 appropriations bills On March 3, 2024, House and Senate appropriators released a package of final fiscal year (FY) 2024 appropriations bills. AgencyIQ has the highlights. As POLITICO reported , this generally represents a 5.2% This is already raising some red flags.

FDA 40

FDA Packaging Science Drugs 40

The Pharma Data

JUNE 18, 2021

The objective of this Phase 3 study is to evaluate the efficacy and safety of risankizumab 180 mg and 360 mg as maintenance therapy versus withdrawal from risankizumab treatment (control) in patients with moderate to severe Crohn’s disease who responded to risankizumab IV induction treatment in the ADVANCE and MOTIVATE studies.

Disease 40

Disease Treatment Therapies Trials 40

The Pharma Data

JUNE 18, 2021

The ADVANCE study included patients with past intolerance or inadequate response to conventional therapy (non-bio-IR) and/or biologic therapy (bio-IR). The ADVANCE study included a mixed population of patients who had responded inadequately or are intolerant to conventional and/or biologic therapy. NORTH CHICAGO, Ill. ,

Disease 40

Disease Therapies Treatment Clinical Trials 40

The Pharma Data

FEBRUARY 22, 2021

U-ACCOMPLISH is a Phase 3 multicenter, randomized, double-blind, placebo-controlled induction study to evaluate the efficacy and safety of upadacitinib 45 mg once daily for induction therapy compared to placebo in subjects with moderate to severe ulcerative colitis. RINVOQ (upadacitinib) [Package Insert]. ClinicalTrials.gov.

Disease 52

Disease Treatment Therapies Trials 52

Codon

FEBRUARY 9, 2025

To achieve this, E11 Bio synthesizes protein barcodes (short peptides with unique amino acid sequences), packages them into AAV vectors (engineered, non-harmful viruses for drug delivery), and delivers these into the brain tissue. A light microscope and image of a barcoded hippocampus at E11 Bio.

Research 100

Research Disease Engineering Regulations 100

Codon

FEBRUARY 23, 2025

After decades of research into therapies and preventive measures, though, global AIDS deaths have now fallen to about 600,000 annually. Starting in 2007, a human trial in Ecuador and Peru found that this drug duo reduced HIV incidence by 44 percent among men who have sex with men; adherence issues likely prevented full protection.

Clinical Trials 68

Clinical Trials Virus Vaccine Trials 68