MedPath

Clinical Trial News

Roche Unveils TAGS Technology: Revolutionary Multi-Pathogen Detection System for Infectious Diseases

  • Roche introduces TAGS (Temperature-Activated Generation of Signal) technology, enabling detection of up to 15 diagnostic targets from a single patient sample, marking a significant advance in infectious disease testing.
  • The first application, cobas Respiratory flex panel, can simultaneously screen for 12 respiratory viruses including influenza, COVID-19, and RSV, compatible with existing Roche diagnostic platforms.
  • The technology enhances conventional PCR testing by incorporating multiple diagnostic criteria, potentially revolutionizing hospital laboratory testing efficiency and improving patient care delivery.

FDA Accepts LEO Pharma's Delgocitinib Cream NDA for Chronic Hand Eczema

  • The FDA has accepted LEO Pharma's New Drug Application (NDA) for delgocitinib cream 2% for treating moderate to severe Chronic Hand Eczema (CHE) in adults.
  • The NDA is supported by Phase 3 DELTA 1 and DELTA 2 clinical trials, which demonstrated the efficacy and safety of delgocitinib cream compared to a cream vehicle.
  • Delgocitinib cream is an investigational topical pan-JAK inhibitor that addresses the unmet need for CHE patients who have inadequate responses to topical corticosteroids.
  • The FDA regulatory review process is expected to conclude in the second half of 2025, potentially offering a new treatment option for this debilitating condition.

Open-label Multi-site Extension Trial in Subjects Who Completed the DELTA 1 or DELTA 2 Trials

NCT04949841CompletedPhase 3
LEO Pharma
Posted 8/23/2021

Efficacy and Safety of Delgocitinib Cream in Adults With Moderate to Severe Chronic Hand Eczema

NCT04871711CompletedPhase 3
LEO Pharma
Posted 5/10/2021

Efficacy and Safety of Delgocitinib Cream in Adults With Moderate to Severe Chronic Hand Eczema (DELTA 2)

NCT04872101CompletedPhase 3
LEO Pharma
Posted 5/25/2021

Cenna Biosciences Awarded NIH Grant for Alzheimer's Disease Drug Development

  • Cenna Biosciences receives a $2.7M Phase II SBIR grant from the NIH's National Institute on Aging to advance Nubytide™ for Alzheimer's disease.
  • Nubytide™, a novel peptide drug, targets the production of toxic Aβ species, offering a potentially safer alternative to monoclonal antibody therapies.
  • The funding supports IND-enabling studies and Phase 1 clinical trials, with an IND filing anticipated in early 2025.
  • Cenna's approach aims to modify the disease course, potentially preventing or delaying Alzheimer's progression, addressing a critical unmet need.

Rimegepant Shows Consistent Efficacy and Safety in Pooled Migraine Trial Analysis

  • Pooled analysis of four randomized, placebo-controlled trials demonstrates rimegepant's statistically significant benefits in acute migraine treatment.
  • Rimegepant 75 mg showed superiority over placebo in achieving pain freedom and freedom from the most bothersome symptom at 2 hours post-dose.
  • The analysis supports early and consistent use of rimegepant, highlighting its flexibility for both acute and preventive migraine treatment.
  • Rimegepant's effectiveness leads to reduced use of rescue medications, potentially decreasing the risk of medication overuse headache and chronic migraine.

FDA Approves Arimoclomol for Niemann-Pick Disease Type C After Multiple Failed Trials

  • Arimoclomol, previously developed by Orphazyme, receives FDA approval for treating Niemann-Pick disease type C, marking a significant milestone after 13 years of development.
  • The drug's approval offers a new therapeutic option for patients with this rare and progressive genetic disorder, addressing a critical unmet medical need.
  • Despite earlier setbacks in clinical trials, arimoclomol's eventual approval underscores the FDA's commitment to providing treatments for rare diseases.
  • This approval highlights the importance of continued research and regulatory flexibility in bringing potentially life-changing therapies to patients with limited options.

Vicebio Secures $100 Million to Advance RSV and hMPV Combination Vaccine

  • Vicebio Ltd. has secured $100 million in Series B funding to advance its next-generation vaccines for respiratory illnesses, including RSV and hMPV.
  • The funding will support Phase I testing of VXB-241, a bivalent vaccine targeting RSV and hMPV, with initial readouts expected in mid-2025.
  • Vicebio will also use the funds to develop VXB-251, a trivalent vaccine targeting RSV, hMPV, and parainfluenza virus 3 (PIV3).
  • Vicebio's Molecular Clamp platform stabilizes viral glycoproteins, enhancing the immune response and offering broad applicability to various viruses.

A Study of RSV-HMPV Bivalent Vaccine VXB-241 in Older Adults

NCT06556147Active, Not RecruitingPhase 1
Vicebio Australia Proprietary Limited
Posted 8/13/2024

Aptar's N-Sorb Nitrosamine Mitigation Solution Accepted into FDA's Emerging Technology Program

  • Aptar's N-Sorb, utilizing the 3-Phase Activ-Polymer™ platform, has been accepted into the FDA's Emerging Technology Program, signaling a significant advancement in pharmaceutical safety.
  • N-Sorb addresses N-nitrosamine impurities in drugs, classified as probable human carcinogens, by integrating into packaging to react with precursors and scavenge impurities.
  • This active packaging intervention could eliminate the need for drug reformulation, supporting compliance with FDA and EMA regulations and potentially accelerating drug development.
  • The FDA's selective program acceptance highlights N-Sorb's promise in modernizing pharmaceutical manufacturing and quality control, offering a potential pathway for expedited regulatory review.

DBV Technologies Concludes VITESSE Trial Screening for Viaskin Peanut Patch

  • DBV Technologies completed screening for its VITESSE Phase 3 trial, surpassing recruitment goals for peanut-allergic children aged 4-7.
  • The VITESSE trial, evaluating the Viaskin Peanut Patch, is the largest immunotherapy study for this patient group, spanning 86 global sites.
  • Topline data from the VITESSE trial, assessing the safety and efficacy of Viaskin Peanut Patch, is anticipated in Q4 2025.
  • DBV Technologies is focusing on advancing the Viaskin Peanut Patch program to support a Biologic License Application submission.

Ruxolitinib Plus TKI Therapy Shows Promise in Chronic Myeloid Leukemia

  • Adding ruxolitinib to tyrosine kinase inhibitors (TKIs) significantly increased deep molecular response rates in chronic-phase chronic myeloid leukemia (CP-CML) patients.
  • The combination therapy led to a higher proportion of patients meeting criteria for treatment discontinuation compared to TKI therapy alone.
  • The SWOG S1712 clinical trial demonstrated that ruxolitinib may sensitize leukemic stem cells to TKIs, potentially eradicating measurable residual disease.
  • Toxicity profiles were similar between the two arms, with a slightly higher incidence of grade 1/2 anemia in the ruxolitinib arm.

Active Breaks Show Promise in Boosting Academic Performance for Children with and without ADHD

  • A new study, Break4Brain, investigates the impact of physical activity (PA) on academic achievement in children, focusing on those with and without ADHD.
  • The study employs a two-phase design, including a crossover study and a cluster randomized controlled trial (RCT), to assess acute and chronic PA effects.
  • Researchers will evaluate changes in brain function, academic performance, working memory, and attention through various experimental conditions and interventions.
  • The Break4Brain project anticipates that PA will enhance cognitive and academic outcomes, potentially offering a novel approach to support children with ADHD.

Trending News

1

FDA Approves Streamlined Access for Bristol Myers Squibb CAR T Cell Therapies

3 days ago
2

UCB's Fenfluramine Achieves Positive Phase 3 Results in Ultra-Rare CDKL5 Deficiency Disorder

3 days ago
3

FDA Approves Gamifant as First Treatment for Macrophage Activation Syndrome in Still's Disease

2 days ago
4

Torrent Pharma Advances $2.4 Billion Acquisition of JB Chemicals in Major Industry Consolidation Move

2 days ago
5

First European Patient Receives Breakthrough Treatment for Ultra-Rare APDS Immune Disorder

3 days ago
6

STENTiT Initiates First-in-Human Trial of Regenerative Stent for Chronic Limb-Threatening Ischemia

2 days ago
7

Schrödinger's SGR-1505 Receives FDA Fast Track Designation for Relapsed Waldenström Macroglobulinemia

2 days ago
8

ProQR Submits First Clinical Trial Application for RNA Editing Platform with AX-0810 Targeting Cholestatic Liver Disease

3 days ago
9

BioCryst Pharmaceuticals Divests European ORLADEYO Rights for $264 Million to Achieve Debt-Free Status

2 days ago
10

Tilray Medical Publishes Pharmacokinetic Study Comparing Oral and Oromucosal Cannabis Formulations

3 days ago
Subscribe Icon

Daily Pharma Insights

Get curated, high-impact pharmaceutical news delivered to your inbox every morning.

  • Critical clinical trial updates & results
  • Regulatory approvals & strategic partnerships
  • Market access decisions & commercial developments
© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy