Clinical Trial News Archive - October 2021
October 1, 2021
- At Week 104, 75% of Patients with Ulcerative Colitis Taking Mirikizumab Maintained Symptomatic Remission in Phase 2 Study
- Merck Says Covid Drug Cut Hospitalization, Deaths by Half
- Merck and Ridgeback’s Investigational Oral Antiviral Molnupiravir Reduced the Risk of Hospitalization or Death by Approximately 50 Percent Compared to Placebo for Patients with Mild or Moderate COVID-19 in Positive Interim Analysis of Phase 3 Study
October 2, 2021
- AnaptysBio Presents Updated Data From Imsidolimab Phase 2 GALLOP Trial in Generalized Pustular Psoriasis
- Amgen and Kyowa Kirin Present Positive Late-Breaking Data From Phase 2 Study Of AMG 451/KHK4083 In Adult Patients With Moderate-to-Severe Atopic Dermatitis At EADV Congress
- Janssen Announces Phase 2b Data Demonstrating its Investigational RSV Adult Vaccine Provided 80% Protection against Lower Respiratory Infections in Older Adults
October 4, 2021
- RedHill Biopharma Reports Further Analysis of Phase 2/3 Data Including a 62% Reduction in Mortality with Oral Opaganib in Moderately Severe COVID-19 Patients
- Kintor Pharma Announces First Patient Dosing in Phase III Clinical Trial of Proxalutamide for the Treatment of Hospitalized COVID-19 Patients in US
- Nabriva Publishes Data Demonstrating the Potent Anti-Inflammatory Properties of XENLETA (lefamulin)
- Inhibikase Therapeutics Announces Interim Three-month Results from Chronic Toxicology Studies of its Oral c-Abl Kinase Inhibitor, IkT-148009, in Development for Treatment of Parkinson's Disease
- ViiV Healthcare Submits FDA Application for First Dispersible Single Tablet Regimen Containing Dolutegravir (DTG) for Children Living with HIV
October 5, 2021
- New Research Demonstrates Thymosin Beta 4's Potential Positive Effects on Alzheimer's Disease
- AZD7442 Request for Emergency Use Authorization for COVID-19 Prophylaxis Filed in US
- Johnson & Johnson Announces Submission of Emergency Use Authorization Amendment to the U.S. FDA to Support Booster of its Single-Shot COVID-19 Vaccine
October 6, 2021
- Janssen Announces Novel Mechanism of Action that Shows Promise Against Dengue in Data Published in Nature
- Acer Therapeutics and Relief Therapeutics Announce FDA Acceptance for Filing of New Drug Application for ACER-001 to Treat Urea Cycle Disorders
October 7, 2021
- Bristol Myers Squibb Provides Update on Phase 2 Study of Deucravacitinib in Patients With Moderate to Severe Ulcerative Colitis
- FDA Advisory Committee Recommends Use of Investigational Drug Maribavir (TAK-620) to Treat Post-Transplant Recipients with Cytomegalovirus (CMV) Infection and Disease Refractory to Treatment With or Without Resistance
- CytoDyn Announces Study to Evaluate Potential Synergistic Effects of Leronlimab with Immune Checkpoint Blockade (ICB)
- Inhalon Doses First Patient in Phase 1 Study of Inhaled IN-006 to Treat COVID-19
- Bristol Myers Squibb Provides Update on Phase 2 Study of Deucravacitinib in Patients With Moderate to Severe Ulcerative Colitis
- Positive Results From the First Study of High-Dose Quadrivalent Influenza Vaccine With a Covid-19 mRNA Booster Support Co-Administration Recommendations
October 8, 2021
- Tezepelumab Granted Orphan Drug Designation in the US for Eosinophilic Esophagitis
- Genentech’s Anti-Amyloid Beta Antibody Gantenerumab Granted FDA Breakthrough Therapy Designation in Alzheimer’s Disease
- IMM-124E – Demonstrates Antiviral T-Cell Immunity
October 11, 2021
- AZD7442 Reduced Risk of Developing Severe COVID-19 or Death in TACKLE Phase III Outpatient Treatment Trial
- Can an Already Approved Drug Treat Alzheimer's Disease?
- Merck and Ridgeback Announce Submission of Emergency Use Authorization Application to the U.S. FDA for Molnupiravir, an Investigational Oral Antiviral Medicine, for the Treatment of Mild-to-Moderate COVID-19 in At Risk Adults
October 13, 2021
- Bio-Techne Announces ExoDx Prostate Test Data Publication in the Journal of Prostate Cancer and Prostatic Diseases
- Aluda Pharmaceuticals announces results for a novel anti-COVID agent with both anti-viral and anti-inflammatory actions
- Data Safety Monitoring Board Recommends Completion of Phase II Study to Evaluate the Efficacy and Safety of ARAKODA (tafenoquine) for Treatment of Mild-Moderate Covid-19 Disease
- BioLineRx Announces Positive Results from Pharmacoeconomic Study Positioning Motixafortide as Potential Standard of Care in Stem Cell Mobilization
October 14, 2021
- Journal of Infectious Diseases and Treatment Publishes Positive Trial Data of Aviptadil in High Comorbidity Patients Suffering from Critical COVID-19 with Respiratory Failure
- Moderna Announces FDA Advisory Committee Unanimously Votes in Support of Emergency Use for a Booster Dose of Moderna’s COVID-19 Vaccine in the U.S.
- FDA Accepts REGEN-COV (casirivimab and imdevimab) for Priority Review for Treatment and Prophylaxis of COVID-19
October 15, 2021
- Imfinzi Plus Tremelimumab Significantly Improved Overall Survival in HIMALAYA Phase III Trial in 1st-line Unresectable Liver Cancer
- Phase II Data Of Medigen COVID-19 Vaccine, Reviewed And Published In The Lancet Respiratory Medicine
- Johnson & Johnson COVID-19 Vaccine Booster Shot Unanimously Recommended for Emergency Use Authorization by U.S. FDA Advisory Committee
October 16, 2021
October 17, 2021
October 18, 2021
- Entasis Therapeutics Announces Positive Topline Results for Sulbactam-Durlobactam (SUL-DUR) from Phase 3 ATTACK Trial
- United Therapeutics Provides an Update on the Progress of the Tyvaso DPI New Drug Application
- Valneva Reports Positive Phase 3 Results for Inactivated, Adjuvanted COVID-19 Vaccine Candidate VLA2001
October 19, 2021
- Tirzepatide Results Published in The Lancet Show Superior A1C and Body Weight Reductions Compared to Insulin Glargine in Adults with Type 2 Diabetes with Increased Cardiovascular Risk
- FDA Pre-Submission for Saliva-Based Glucose Test to Replace Invasive Finger-Prick
- Iterion Therapeutics Announces Initiation of Phase 1 Clinical Trial to Study Tegavivint in Acute Myeloid Leukemia
October 20, 2021
- Senhwa Presents Positive Initial Data from Phase 2 Clinical Trial of Silmitasertib (CX-4945) in Moderate COVID-19 Patients At the ISIRV-WHO Conference
- Moderna Announces FDA Authorization of a Booster Dose of Moderna’s COVID-19 Vaccine in the U.S.
- Johnson & Johnson COVID-19 Vaccine Booster Shot Authorized for Emergency Use by U.S. FDA
- Aquilino Cancer Center Study on Psilocybin Therapy for Depression in Cancer Patients Demonstrates Safety and Feasibility
- Menarini Group and Radius Health Announce Positive Phase 3 Topline Results from the EMERALD Trial Evaluating Elacestrant in Breast Cancer
October 21, 2021
- U.S. CDC Advisory Committee on Immunization Practices Recommends Booster Vaccination with Moderna’s COVID-19 Vaccine
- U.S. CDC Advisory Committee Unanimously Recommends Johnson & Johnson COVID-19 Vaccine as a Booster for All Eligible Individuals Who Receive Authorized COVID-19 Vaccines
- Pfizer and BioNTech Announce Phase 3 Trial Data Showing High Efficacy of a Booster Dose of Their COVID-19 Vaccine
- Global Down Syndrome Foundation Funding For Alzheimer's Research Results In Milestone Clinical Trial For People With Down Syndrome
- New Study Supports Coffee and Caffeine Can Reduce Kidney Stones Risk
October 22, 2021
- Helixmith Announces Phase 3 Study Results of Novel Gene Therapy Treatment for Diabetic Foot Ulcers at 2021 Annual Meeting of Diabetic Foot Ulcer Conference (DFCon)
- Roche Announces Collaboration with Atea Pharmaceuticals to Develop a Potential Oral Treatment for COVID-19 Patients
- UCB Presents Number Needed to Treat Analysis for Bimekizumab in Moderate to Severe Plaque Psoriasis at AMCP Nexus
October 25, 2021
- Lancet publishes phase 2 data on C21 in COVID-19
- Moderna Announces Positive Top Line Data from Phase 2/3 Study of COVID-19 Vaccine in Children 6 to 11 Years of Age
- Second Clinical Trial Collaboration Initiated to Evaluate Datopotamab Deruxtecan in Combination with KEYTRUDA® (pembrolizumab) in Patients with Metastatic Non-Small Cell Lung Cancer
- Merck Announces Positive Top-Line Results from Pivotal Phase 3 Trials Evaluating Investigational, Once-Daily Oral Fixed Dose Combination of Doravirine/Islatravir for the Treatment of People with HIV-1 Infection
October 26, 2021
- Moderna Announces First Participant Dosed in Phase 3 Pivotal Registration Study of Its mRNA Cytomegalovirus (CMV) Vaccine
- Allergan, an AbbVie Company, to Present New Data on Investigational AGN-190584 for the Treatment of Presbyopia
- Peer-Reviewed Study Validates Bamboo Health's NarxCare as Effective Patient Screening Solution for Opioid Risk
- INOVIO Completes Enrollment of Phase 1B Clinical Trial for its DNA Vaccine Candidate Against Lassa Fever, INO-4500, in West Africa
- Gilead and Merck Initiate Phase 2 Study Evaluating an Oral Weekly Combination Regimen of Investigational Lenacapavir and Investigational Islatravir for HIV-1 Treatment in Virologically Suppressed Adults
- FDA Advisory Committee Votes in Favor of Granting Emergency Use Authorization for the Pfizer-BioNTech COVID-19 Vaccine in Children 5 to <12 Years
October 27, 2021
- GABAeron Presents Promising Preclinical Data on Stem Cell-Based Therapy for Alzheimer's Disease
- Novavax Files for Authorization of its COVID-19 Vaccine in the United Kingdom
- Merck Presents New Data from Ongoing Phase 2b Clinical Trial Evaluating Efficacy and Safety of Investigational Islatravir in Combination With Doravirine Through 144 Weeks for HIV-1 Treatment at EACS 2021
October 28, 2021
- AbbVie Announces ABBV-951 (Foslevodopa/Foscarbidopa) Showed Improvement in Controlling Motor Fluctuations Compared to Oral Levodopa/Carbidopa Medication in Pivotal Phase 3 Trial in Patients with Advanced Parkinson's Disease
- Clinical Trial Research at Wolfe Eye Clinic contributes to FDA Approval of Genentech's Susvimo, a First-of-Its-Kind Therapeutic Approach for Wet Age-Related Macular Degeneration
- Immunic, Inc. Announces Completion of Enrollment of its Phase 2 CALDOSE-1 Trial of IMU-838 in Moderate-to-Severe Ulcerative Colitis
- Rafael Pharmaceuticals Provides Update on Pivotal Phase 3 Clinical Trial in Patients with Metastatic Pancreatic Cancer and Interim Analysis of Pivotal Phase 3 Clinical Trial in Patients with Relapsed or Refractory Acute Myeloid Leukemia
October 29, 2021
- First patient recruited into Alzinova's phase 1b clinical study with the oligomer-specific ALZ-101 vaccine against Alzheimer's disease
- Pfizer and BioNTech Receive First U.S. FDA Emergency Use Authorization of a COVID-19 Vaccine in Children Ages 5 Through 11 Years
- Novavax Files for Provisional Approval of its COVID-19 Vaccine in Australia
October 31, 2021
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