Clinical Trial News Archive - October 2022
October 3, 2022
- Calithera Receives FDA Fast Track Designation for Sapanisertib for the Treatment of NRF2-mutated Squamous Lung Cancer
- Poxel Announces PXL770 Granted Orphan Drug Designation from the U.S. FDA for Autosomal-Dominant Polycystic Kidney Disease (ADPKD)
- REGENXBIO Announces Additional Positive Interim Data from Trials of RGX-314 for the Treatment of Wet AMD
- Biogen and Denali Therapeutics Announce Initiation of the Phase 3 LIGHTHOUSE Study in Parkinson’s Disease Associated with LRRK2 Pathogenic Mutations
October 4, 2022
- NIH DREAM Study Finds Viagra and Cialis Do Not Reduce Risk of Alzheimer’s and Related Dementias
- NIH-Supported Clinical Trial of Phage Therapy for Cystic Fibrosis Begins
- Immutep Receives FDA Fast Track Designation for LAG-3 Therapeutic Eftilagimod Alpha for First Line Non-Small Cell Lung Cancer
- Lumen Bioscience Announces Preclinical Data Demonstrating Needle Free, Spirulina-produced Vaccination Offering Protection Against Malaria
October 5, 2022
October 6, 2022
- Galectin Therapeutics Reports the Positive Outcome of the Second Data and Safety Monitoring Board Meeting for NAVIGATE, its Seamless, Adaptive Phase 2b/3 Study of Belapectin in Patients with Liver Cirrhosis Caused by Non-Alcoholic Steatohepatitis
- Annovis Bio Announces FDA Authorization to Proceed with Phase 2/3 Trial for Buntanetap in Alzheimer's Disease
- Novel Clinical Trial Begins to Help Black and Latina Women Concerned About Chemotherapy-Induced Hair Loss
- Opiant Pharmaceuticals Announces Completion of Enrollment in Phase 2 Clinical Trial of OPNT002, Nasal Naltrexone, in Patients with Alcohol Use Disorder
- Revive Therapeutics Provides Update on Phase 3 Clinical Trial for Bucillamine in COVID-19
- Lilly Receives U.S. FDA Fast Track Designation for Tirzepatide for the Treatment of Adults with Obesity, or Overweight with Weight-Related Comorbidities
- Findings Suggest COVID-19 Rebound Not Caused by Impaired Immune Response
- Provention Bio to Combine Forces with Sanofi to Support Potential U.S. Launch of Teplizumab for Delay in Onset of Clinical Type 1 Diabetes (T1D) in At-Risk Individuals
October 7, 2022
October 10, 2022
- Supernus Provides Regulatory Update on SPN-830
- Ascletis Announces Dosing of 24 Healthy Subjects of the First 3 Cohorts in Multiple-Dose Escalation Phase I Clinical Trial of Oral RdRp Inhibitor ASC10 for COVID-19
- Merck Announces Positive Top-line Results from Pivotal Phase 3 STELLAR Trial Evaluating Sotatercept for the Treatment of Adults with Pulmonary Arterial Hypertension (PAH)
- Biogen Announces First Patient Dosed in Pivotal Study of Litifilimab in Cutaneous Lupus Erythematosus, an Autoimmune Disease Affecting Skin
October 11, 2022
- VigiLanz Announces Launch of New Clinical Trial Patient Identification Solution
- Monoclonal Antibody Improves Cat Allergen Immunotherapy
October 12, 2022
- Moderna Receives FDA Authorization for Emergency Use of Omicron-Targeting Bivalent COVID-19 Booster Vaccine for Children and Adolescents 6 to 17 Years of Age
- AIM ImmunoTech to Evaluate Ampligen in Clinical Study for the Treatment of Post-COVID Conditions
- Monkeypox Treatment Trial Begins in the Democratic Republic of the Congo
- Pfizer and BioNTech Receive U.S. FDA Emergency Use Authorization for Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine Booster in Children 5 Through 11 Years of Age
- Coherus and Junshi Biosciences Announce Publication of Positive Results from CHOICE-01, a Phase 3 Clinical Trial Evaluating Toripalimab in Combination with Chemotherapy as First-Line Treatment for Non-Small Cell Lung Cancer, in the Journal of Clinical Oncology
October 13, 2022
- Pfizer and BioNTech Announce Positive Early Data From Clinical Trial of Omicron BA.4/BA.5-Adapted Bivalent Booster in Individuals 18 Years and Older
- BioCorRx Completes Final Subject Enrollment in Phase I Clinical Trial of BICX104, an Implantable Naltrexone Pellet for the Treatment of Opioid Use Disorder
- INOVIO Reports Positive Interim Phase 1/2 Results for INO-3107 for the Treatment of Recurrent Respiratory Papillomatosis
- Novavax COVID-19-Influenza Combination Vaccine Candidate Induced Antibody and T-Cell Responses Against SARS-CoV-2 and Homologous and Heterologous Influenza Strains
October 14, 2022
October 17, 2022
- Milestone Pharmaceuticals Announces Positive Results from Phase 3 RAPID Clinical Trial of Etripamil Nasal Spray in Patients with Paroxysmal Supraventricular Tachycardia
- New Study Shows Racial and Ethnic Differences in the Experience of Menopause Symptoms
- Hair Straightening Chemicals Associated with Higher Uterine Cancer Risk
October 18, 2022
- Noema Pharma Receives FDA Fast Track Designation for Basimglurant
- Lack of global regulatory coordination for cancer clinical trials costs 1.5 million lives a year despite therapies being available
October 19, 2022
- U.S. Centers for Disease Control and Prevention Recommends Novavax COVID-19 Vaccine, Adjuvanted as a Booster in Adults
- BioVie’s Phase 2 Trial Assessing NE3107's Pro-motoric Activity in Parkinson's Disease is Fully Enrolled
October 20, 2022
- Iterum Announces First Patient Dosed in REASSURE, a Phase 3 Clinical Trial of Oral Sulopenem in Uncomplicated Urinary Tract Infections
- First Patient Enrolled in Palatin's Phase 2 study of PL8177 in Ulcerative Colitis Trial
- Three-Dose Hepatitis B Vaccine Regimen Protects People with HIV
October 21, 2022
- ARS Pharmaceuticals Announces FDA Acceptance of NDA for neffy® (epinephrine nasal spray) for the Treatment of Allergic Reactions (type I) including Anaphylaxis
- Eisai Announces Real-World Evidence on the Clinical Effectiveness of Lenvima Monotherapy for the Treatment of Patients with Radioiodine-Refractory Differentiated Thyroid Cancer
- Early HIV Diagnosis and Treatment Important for Better Long-Term Health Outcomes
October 24, 2022
- Tricida Reports Topline Results from the VALOR-CKD Phase 3 Trial of Veverimer
- Aquestive Therapeutics Announces Positive Decision in States’ Suboxone Antitrust Lawsuit on All Claims
- Novartis Investigational Oral Monotherapy Iptacopan Demonstrates Clinically Meaningful Superiority Over Anti-C5 Treatment in Phase III APPLY-PNH Study
- Quizartinib Granted Priority Review in the U.S. for Patients with Newly Diagnosed FLT3-ITD Positive Acute Myeloid Leukemia
October 25, 2022
October 26, 2022
- Boehringer Ingelheim enrolls first patient in Phase III trial of BI 1015550 in idiopathic pulmonary fibrosis
- Perrigo Receives Notification of Postponement for Joint FDA Advisory Committee to Review Opill® Daily Oral Contraceptive for Over-The-Counter (OTC) Use
- Camizestrant Significantly Improved Progression-Free Survival vs. Faslodex in SERENA-2 Phase II Trial in Advanced ER-Positive Breast Cancer
- Capivasertib plus Faslodex Significantly Improved Progression-Free Survival vs. Faslodex in CAPItello-291 Phase III Trial in Advanced HR-Positive Breast Cancer
- NIH-Funded Studies Show Damaging Effects of Vaping, Smoking on Blood Vessels
October 27, 2022
- Neurocrine Biosciences Initiates Phase 2 Clinical Study Evaluating NBI-1117568 in Adults with Schizophrenia
- GSK Reports Outcome from US FDA Advisory Committee Meeting on Daprodustat for Anemia of CKD
- Experimental Monoclonal Antibodies Show Promise Against Epstein-Barr Virus
- INOVIO Provides Update on COVID-19 Heterologous Booster Vaccine Candidate, INO-4800
- NIH Researchers Home in on a New Cause of Stargardt Disease
- Sciwind Biosciences Announces Positive Interim Results from Ongoing Phase 2b Clinical Trial of XW003 (Ecnoglutide) in Patients with Obesity
October 28, 2022
- U.S. FDA Defers Action on Filing for AT-GAA in Late-onset Pompe Disease
- Last patient enrolled in study evaluating the efficacy of MODIA in combination with sublingual buprenorphine/ naloxone for the treatment of OUD
- Y-mAbs Announces Outcome of FDA Advisory Committee Meeting on Omburtamab
October 31, 2022
- Senhwa Announces First Patient Successfully Dosed in Phase I Study of Pindnarulex in Combination with Pfizer's Talazoparib for the Treatment of Prostate Cancer
- Monoclonal Antibody Prevents Malaria Infection in African Adults
- KalVista Pharmaceuticals Announces Positive Phase 1 Data for Orally Disintegrating Tablet Formulation of Sebetralstat for Use in Hereditary Angioedema
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