Clinical Trial News Archive - September 2021
September 1, 2021
- Clinical Trial Provides Preliminary Evidence of a Cure for Myalgic Encephalomyelitis / Chronic Fatigue Syndrome (ME/CFS) and Long Covid
- New Affron saffron study shows a quick effect on sleep at low dosage
- Moderna Announces Submission of Initial Data to U.S. FDA for Its COVID-19 Vaccine Booster
- Merck and Ridgeback Biotherapeutics Announce Initiation of Pivotal Phase 3 MOVe-AHEAD Study Evaluating Molnupiravir for Post-Exposure Prophylaxis of COVID-19 Infection
- Data from NIH/NHLBI-Sponsored Phase 2 Trial of Fostamatinib in Hospitalized COVID-19 Patients Published in Clinical Infectious Diseases
- Astellas Provides Update on ASPIRO Clinical Trial of AT132 in Patients with X-linked Myotubular Myopathy
September 2, 2021
- Pfizer Announces Start of Phase 3 Clinical Trial in Adults for Its Investigational Vaccine Against Respiratory Syncytial Virus (RSV)
- COVID-19 Vaccine Clinical Trial in People With Autoimmune Disease Starts at Feinstein Institutes
September 3, 2021
September 5, 2021
September 6, 2021
September 7, 2021
- Travere Therapeutics Announces Successful Outcome from Type A Meeting with U.S. FDA for Sparsentan in Focal Segmental Glomerulosclerosis
- Unvaccinated Are Nearly 6x More Likely to End Up in the Hospital, According to Analysis of New Jersey's COVID Cases
- Moderna and the Institute for Life Changing Medicines Announce a New Collaboration to Develop an mRNA Therapeutic for Ultra-Rare Disease, Crigler-Najjar Syndrome Type 1
September 8, 2021
- Novavax Initiates Phase 1/2 Clinical Trial of Combination Vaccine for COVID-19 and Seasonal Influenza
- Inventiva Announces the Initiation of its Pivotal Phase III Clinical Trial Evaluating Lanifibranor in NASH
September 9, 2021
- FDA has declined Humanigen’s Emergency Use Authorization (EUA) Request for Lenzilumab in Hospitalized COVID-19 Patients
- FDA Grants Orphan Drug Status to Soin Therapeutics for Low Dose Naltrexone (LDN) to Treat Complex Regional Pain Syndrome (CRPS)
- Imfinzi and Tremelimumab with Chemotherapy Improved Progression-Free Survival by 28% and Overall Survival by 23% in 1st-Line Stage IV Non-Small Cell Lung Cancer vs. Chemotherapy
- Sanofi Provides Update on Phase 3 Study Evaluating Rilzabrutinib for the Treatment of Pemphigus
- Clinical Trial of Investigational Epcoritamab (DuoBody®-CD3xCD20) in Patients with Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma (B-NHL) Published in The Lancet
- Fixed-Dose Combination of Albuterol and Budesonide (PT027) Demonstrated Significant Benefits for Asthma Patients in MANDALA and DENALI Phase III Trials
- Emerging Peer-Reviewed Study Shows Reversal in Biological Hallmarks Responsible for Development of Alzheimer's Disease
- Dermavant Announces First Patient Dosed in ADORING, its Pivotal Phase 3 Clinical Program for Tapinarof for the Topical Treatment of Atopic Dermatitis
- Clinical Trial of Investigational Epcoritamab (DuoBody®-CD3xCD20) in Patients with Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma (B-NHL) Published in The Lancet
September 10, 2021
September 13, 2021
- Johnson & Johnson Ebola Vaccine Regimen Demonstrated Robust and Durable Immune Response in Adults and Children in Data Published in The Lancet Infectious Diseases
- UKLS Trial Meta-Analysis Confirms that Low Dose CT Screening for Lung Cancer Reduces Mortality
September 14, 2021
- Regeneron Announces New U.S. Government Agreement to Purchase Additional Doses of REGEN-COV™ (casirivimab and imdevimab) Antibody Cocktail
- Emalex Biosciences Recruiting People Who Stutter for Phase 2 Clinical Trial for Childhood-Onset Fluency Disorder
- Astellas Reports Update to September 1 Announcement on the ASPIRO Clinical Trial of AT132 in Patients with X-linked Myotubular Myopathy
September 15, 2021
- Lilly to Supply 388,000 Doses of Etesevimab to U.S. Government for Treatment of COVID-19
- Amylyx Pharmaceuticals Announces Plan to Submit New Drug Application (NDA) for AMX0035 for the Treatment of ALS in the Coming Months
- Theravance Biopharma, Inc. Announces Top-line Results from a Phase 3 Study of Ampreloxetine in Patients with Symptomatic Neurogenic Orthostatic Hypotension
- Aegis Sciences Corporation and QURE Announce Groundbreaking Results from InterACT Rx Study Demonstrating Objective Identification of Drug-drug Interactions Linked to Improved Patient Outcomes
- Moderna Highlights New Clinical Data on its COVID-19 Vaccine
September 16, 2021
- Novavax to Participate in University of Oxford Com-COV3 Study Comparing Mixed COVID-19 Vaccine Schedule in Adolescents
- Biogen Announces Positive Topline Results from Phase 2 CONVEY Study for Vixotrigine in Small Fiber Neuropathy
- Emergency Use Authorization for Lilly's Bamlanivimab and Etesevimab Administered Together Expanded to Include Post-Exposure Prophylaxis for COVID-19
- Monopar Initiates Open-Label Phase 1b Clinical Trial Evaluating Camsirubicin in Patients with Advanced Soft Tissue Sarcoma
- FDA Accepts Investigational New Drug Application for Peanut Allergy Candidate Developed by COUR Pharmaceuticals
September 17, 2021
- Novavax Statement on Proof of COVID-19 Vaccine Requirements for PREVENT-19 Clinical Trial Participants in the U.S.
- Novartis Announces Findings From a Real-World Study of Alpelisib Demonstrating Clinical Benefit in People with PIK3CA-Related Overgrowth Spectrum (PROS)
- FDA Advisory Committee Votes Unanimously in Favor of Comirnaty® Booster for Emergency Use in People 65 and Older and Certain High-risk Populations
- Astellas' and Pfizer's XTANDI Reduced Risk of Death by 34% in Men with Metastatic Hormone-Sensitive Prostate Cancer in Study
September 19, 2021
- Datopotamab Deruxtecan Shows Encouraging Tumor Response in Patients with Advanced Non-Small Cell Lung Cancer with Actionable Genomic Alterations
- New Data on Rybrevant (amivantamab-vmjw) in Combination with Lazertinib Show Early Activity in Patients with Non-Small Cell Lung Cancer Whose Disease Has Progressed After Both Osimertinib and Platinum-Based Chemotherapy
- FDA Advisory Committee Votes Unanimously in Favor of COMIRNATY Booster for Emergency Use in People 65 and Older and Certain High-Risk Populations
- Novartis presents new Kisqali data showing longest median overall survival ever reported in HR+/HER2- advanced breast cancer
September 20, 2021
- Mirati Therapeutics Announces Long-term Survival Results from an Exploratory Analysis of Sitravatinib plus Nivolumab in Patients with Non-squamous Non-Small Cell Lung Cancer Who are Resistant to Checkpoint Inhibitors
- Datopotamab Deruxtecan Shows Encouraging Tumor Response in Patients with Advanced Non-Small Cell Lung Cancer with Actionable Genomic Alterations
- AbbVie Submits Regulatory Application to FDA for Risankizumab-rzaa (Skyrizi) for the Treatment of Patients 16 Years and Older with Moderate to Severe Crohn's Disease
- Pfizer and BioNTech Announce Positive Topline Results From Pivotal Trial of COVID-19 Vaccine in Children 5 to 11 Years
September 21, 2021
September 22, 2021
- Veklury (remdesivir) Significantly Reduced Risk of Hospitalization in High-Risk Patients with COVID-19
- Ascentage Pharma’s MDM2-p53 Inhibitor Alrizomadlin (APG-115) Granted Fast Track Designation by the US FDA for the Treatment of Relapsed/Refractory Unresectable or Metastatic Melanoma
- Endeavor BioMedicines Doses First Patient in Phase 2 Clinical Trial of Taladegib (ENV-101) for Idiopathic Pulmonary Fibrosis
- Pfizer and BioNTech Receive First U.S. FDA Emergency Use Authorization of a COVID-19 Vaccine Booster
- Pregnant Women Who Receive COVID-19 Vaccination Pass Protection from the Virus to Their Newborns
September 23, 2021
- Valneva Continues Expansion of Clinical Trials of its Inactivated COVID-19 Vaccine Candidate VLA2001
- BioVaxys Prepares for Groundbreaking Study on reduced ACE2 binding capabilities of Hapten-modified SARS-CoV-2 proteins
- Results from Novavax NanoFlu Influenza Vaccine Phase 3 Clinical Trial Published in The Lancet Infectious Diseases
September 24, 2021
September 25, 2021
September 27, 2021
- Acurx Announces New Microbiome Data from Its Phase 2a Clinical Trial of Ibezapolstat for CDI in a Scientific Poster Presentation at IDWeek 2021 Conference
- Lipidor announces approval to start Phase III clinical study of drug candidate AKP02 for treatment of psoriasis
- CyanVac and Blue Lake Biotechnology Announce First Participant Dosed in a Phase 1 Clinical Trial to Evaluate its CVXGA1 Intranasal COVID-19 Vaccine
- Pfizer Starts Global Phase 2/3 EPIC-PEP Study of Novel COVID-19 Oral Antiviral Candidate for Post-Exposure Prophylaxis in Adults
September 28, 2021
- FDA Grants Priority Review to ViiV Healthcare’s New Drug Application for Cabotegravir Long-Acting for Prevention of HIV
- Sanofi announces positive Phase 1/2 study interim results for its first mRNA-based vaccine candidate
- Pfizer and BioNTech Submit Initial Data to U.S. FDA From Pivotal Trial of COVID-19 Vaccine in Children 5 to <12 Years of Age
- Pfizer Starts Study of mRNA-Based Next Generation Flu Vaccine Program
- Valneva and Pfizer Report Further Positive Phase 2 Results, Including Booster Response, for Lyme Disease Vaccine Candidate
September 29, 2021
- NuCana Receives Fast Track Designation from the U.S. Food and Drug Administration for Acelarin® (NUC-1031) for the Treatment of Biliary Tract Cancer
- Janssen Announces Start of Phase 3 Trial for Investigational Respiratory Syncytial Virus (RSV) Vaccine in Older Adults
- U.S. FDA Accepts Filings for Amicus’ AT-GAA for the Treatment of Pompe Disease
- New Research Supports the Use of Saliva Biomarkers for Sports-Related Concussion
- Ferring Presents Complete Data across Five RBX2660 Trials Demonstrating Consistent and Durable Efficacy in Recurrent C. difficile Infection, as Well as Multiple Analyses Demonstrating Positive Shifts in Microbiome Properties
- New Bimekizumab Two-Year Data in Moderate to Severe Plaque Psoriasis Presented at the 30th European Academy of Dermatology and Venereology Congress
September 30, 2021
- Lilly's Tirzepatide Led to Greater Improvements in Liver Fat Content Compared to Insulin Degludec in Adults with Type 2 Diabetes in SURPASS-3 MRI Sub-Study
- Lilly's Tirzepatide Led to Greater Time in Range Compared to Insulin Degludec in Adults with Type 2 Diabetes in SURPASS-3 CGM Sub-Study
- Alzinova receives approval to start the first clinical study with the oligomer-specific ALZ-101 vaccine in patients with Alzheimer's disease
- New REGEN-COV (casirivimab and imdevimab) Data Show Supportive Results in Patients Hospitalized with COVID-19
- Reata Pharmaceuticals Plans NDA Submission for Omaveloxolone in First Quarter of 2022 Following Completion of Pre-NDA Meeting with FDA
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