FDA Grants Priority Review to Merck ’s New Biologics License Application for V116, an Investigational, 21-valent Pneumococcal Conjugate Vaccine Specifically Designed to Protect Adults
Acceptance based on results from multiple Phase 3 trials
If approved, V116 would be the first pneumococcal conjugate vaccine specifically designed for adults
The 21 serotypes covered by V116 are responsible for approximately 83% of invasive... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - December 19, 2023 Category: Pharmaceuticals Source Type: clinical trials
Two Phase 3 Trials of Datopotamab Deruxtecan Plus Durvalumab Initiated in Patients Across Two Breast Cancer Subtypes
TROPION-Breast04 is evaluating Daiichi Sankyo and AstraZeneca’s datopotamab deruxtecan plus durvalumab as neoadjuvant treatment for early-stage triple negative and HR low, HER2 low or negative breast cancers
TROPION-Breast05 is evaluating... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - December 18, 2023 Category: Pharmaceuticals Source Type: clinical trials
Azura Ophthalmics Announces Positive Results from Phase 2 Clinical Trial of AZR-MD-001 in Patients with Contact Lens Discomfort
Study met its primary endpoint and showed significant and clinically meaningful improvements in multiple symptoms of Contact Lens Discomfort and signs of concomitant Meibomian Gland Dysfunction
Patients in the AZR-MD-001 arm gained at least three... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - December 18, 2023 Category: Pharmaceuticals Source Type: clinical trials
Invivyd Announces Positive Initial Results from Ongoing CANOPY Phase 3 Pivotal Clinical Trial Investigating VYD222 for the Prevention of COVID-19
VYD222 produced high serum virus neutralizing antibody titer levels in immunocompromised participants
Data supportive of an immunobridging approach to the EVADE study of adintrevimab
Overall favorable safety and tolerability profile of VYD222... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - December 18, 2023 Category: Pharmaceuticals Source Type: clinical trials
Cedar Clinical Research selected as clinical research site for Beckley Psytech's Phase 2b Study
VANCOUVER, BC, Dec. 15, 2023. Numinus Wellness Inc. ( " Numinus " or the " Company " ), a mental health care company advancing traditional and innovative behavioral health treatments with a focus on safe, evidence-based psychedelic-assisted... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - December 16, 2023 Category: Pharmaceuticals Source Type: clinical trials
FDA approves initiation of Phase II clinical trial of MTX652 in Acute Kidney Injury
CAMBRIDGE, England, Dec. 14, 2023. Mission Therapeutics ( " Mission " or the " Company " ), a clinical-stage biotech developing first-in-class therapeutics targeting mitophagy, today announces that the US Food and Drug Administration (FDA) has approved... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - December 15, 2023 Category: Pharmaceuticals Source Type: clinical trials
NIH Research Identifies Opportunities to Improve Future HIV Vaccine Candidates
December 14, 2023 -- An effective HIV vaccine may need to prompt strong responses from immune cells called CD8+ T cells to protect people from acquiring HIV, according to a new study from researchers at the National Institute of Allergy and... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - December 14, 2023 Category: Pharmaceuticals Source Type: clinical trials
A Study of ASP1012 in Adults With Solid Tumors
Conditions: Solid Tumor Interventions: Drug: ASP1012; Drug: Pembrolizumab Sponsors: Astellas Pharma Global Development, Inc. Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - December 14, 2023 Category: Research Source Type: clinical trials
Acesion Pharma announces Nature Medicine publication of clinical results in Atrial Fibrillation
COPENHAGEN, Denmark, Dec. 13, 2023. Acesion Pharma ( " Acesion " or " the Company " ), a biotech company pioneering first-in-class novel therapies for atrial fibrillation ( " AF " ), the most common cardiac arrhythmia, today announces the publication of data... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - December 14, 2023 Category: Pharmaceuticals Source Type: clinical trials
NeuroSense Reports New Data: Statistically Significant Clinical Efficacy in Phase 2b ALS Trial
A statistically significant, 37.4% difference (P=0.03), slowing of disease progression in ALSFRS-R, in patients treated with PrimeC compared to placebo, in the pre-specified Per Protocol (PP) population analysis
Neurofilament biomarker results... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - December 14, 2023 Category: Pharmaceuticals Source Type: clinical trials
Moderna and Merck Announce mRNA-4157 (V940) in Combination with Keytruda ® (pembrolizumab) Demonstrated Continued Improvement in Recurrence-Free Survival and Distant Metastasis-Free Survival in Patients with High-Risk Stage III/IV Melanoma Following Complete Resection Versus KEYTRUDA At Three Years
At a median planned follow-up of approximately three years, mRNA-4157 (V940) in combination with KEYTRUDA reduced the risk of recurrence or death by 49% (HR=0.510 [95% CI, 0.288-0.906]; one-sided nominal p=0.0095) and the risk of distant... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - December 14, 2023 Category: Pharmaceuticals Source Type: clinical trials
MindMed Announces Positive Topline Results from Phase 2b Trial of MM-120 in Generalized Anxiety Disorder
Trial met its primary endpoint with MM-120 demonstrating a statistically significant dose-dependent improvement in HAM-A scores four weeks after a single-dose
MM-120 100µg demonstrated a clinically and statistically significant HAM-A... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - December 14, 2023 Category: Pharmaceuticals Source Type: clinical trials
FDA Grants Priority Review to Amgen's Tarlatamab Application for Advanced Small Cell Lung Cancer
Currently There are no Approved Therapeutic Options for Third-Line Treatment of Advanced SCLC1
If Approved, Tarlatamab Would be the First BiTE® Therapy for a Major Solid Tumor
FDA Target Action Date is June 12, 2024
THOUSAND OAKS, Calif.,... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - December 13, 2023 Category: Pharmaceuticals Source Type: clinical trials
Ilofotase Alfa for Prevention of Renal Damage After Cardiac Surgery
Conditions: Open Heart Surgery; Renal Injury Interventions: Drug: Ilofotase alfa; Drug: Placebo Sponsors: AM-Pharma; FGK Clinical Research GmbH Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - December 13, 2023 Category: Research Source Type: clinical trials
Zepbound achieved additional 6.7% weight loss following a 36-week open-label lead-in period, for a total mean weight loss of 26.0% from study entry over 88 weeks
INDIANAPOLIS, Dec. 11, 2023. Detailed results from SURMOUNT-4, which showed Zepbound (tirzepatide) injection achieved superior mean percent change in body weight compared to placebo in adults with obesity or overweight with weight-related... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - December 12, 2023 Category: Pharmaceuticals Source Type: clinical trials
