Clinical Trial News Archive - September 2021
September 1, 2021
- 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
September 2, 2021
September 5, 2021
September 7, 2021
September 9, 2021
- 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
- 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
- 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 14, 2021
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
- 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
- Emergency Use Authorization for Lilly's Bamlanivimab and Etesevimab Administered Together Expanded to Include Post-Exposure Prophylaxis for COVID-19
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
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
September 20, 2021
- Datopotamab Deruxtecan Shows Encouraging Tumor Response in Patients with Advanced Non-Small Cell Lung Cancer with Actionable Genomic Alterations
- 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
- Pfizer and BioNTech Receive First U.S. FDA Emergency Use Authorization of a COVID-19 Vaccine Booster
September 28, 2021
- FDA Grants Priority Review to ViiV Healthcare’s New Drug Application for Cabotegravir Long-Acting for Prevention of HIV
- 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
September 29, 2021
- U.S. FDA Accepts Filings for Amicus’ AT-GAA for the Treatment of Pompe Disease
- 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
- 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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