Clinical Trial News Archive - November 2020
November 2, 2020
- First Healthy Volunteer Dosed in Symvivo’s Phase 1 Clinical Trial of bacTRL-Spike™, an Oral COVID-19 Vaccine Candidate
- Novavax Announces Facility Expansion to Support Global Vaccine Development
- CureVac Reports Positive Interim Phase 1 Data for its COVID-19 Vaccine Candidate CVnCoV
November 3, 2020
- GW Pharmaceuticals Initiates Pivotal Phase 3 Study of Nabiximols for Multiple Sclerosis-Associated Spasticity
- Bristol Myers Squibb Announces Deucravacitinib (BMS-986165) Demonstrated Superiority to Placebo and Otezla® (apremilast) in Pivotal Phase 3 Psoriasis Study
- CEPI Extends Partnership with Clover Biopharmaceuticals to Fund COVID-19 Vaccine Candidate Through Global Phase 2/3 Study to Licensure
November 4, 2020
November 5, 2020
November 6, 2020
November 7, 2020
November 9, 2020
- CNS Pharmaceuticals Announces Adaptive Trial Design For Berubicin Phase 2 Clinical Trial To Be Submitted for FDA Review
- Supernus Provides Regulatory Updates for SPN-812 and SPN-830
- Tezepelumab NAVIGATOR Phase 3 Trial Met Primary Endpoint Of A Statistically Significant And Clinically Meaningful Reduction In Exacerbations In A Broad Population Of Patients With Severe Asthma
- ViiV Healthcare Announces Investigational Injectable Cabotegravir is Superior to Oral Standard of Care for HIV Prevention in Women
- Bristol Myers Squibb Presents Late-Breaking Phase 2 Data Demonstrating the Safety and Efficacy of Deucravacitinib (BMS-986165) in Patients with Psoriatic Arthritis
- Pfizer and BioNTech Announce Vaccine Candidate Against COVID-19 Achieved Evidence of Efficacy in First Interim Analysis from Phase 3 Study
- Novavax COVID-19 Vaccine Granted Fast Track Designation by U.S. FDA
- ImmunityBio’s hAd5 COVID-19 Vaccine Candidate Stimulates Memory T-Cell Recall in Patients Infected with SARS-CoV-2
- Lilly's Neutralizing Antibody Bamlanivimab (LY-CoV555) Receives FDA Emergency Use Authorization for the Treatment of Recently Diagnosed COVID-19
November 10, 2020
- Tezepelumab NAVIGATOR Phase III Trial Met Primary Endpoint of a Statistically Significant and Clinically Meaningful Reduction in Exacerbations in a Broad Population of Patients with Severe Asthma
- Verrica Pharmaceuticals Announces Positive Topline Results in Phase 2 Clinical Study of VP-102 in Patients with External Genital Warts (CARE-1)
- Inventiva Receives Positive FDA Feedback to Advance its Lead Drug Candidate Lanifibranor into Pivotal Phase III in NASH
- CureVac Publishes Detailed Interim Data from the Phase 1 Study of its COVID-19 Vaccine Candidate CVnCoV
- ImmunityBio, NantKwest Announce Positive Interim Phase 1 Safety Data of hAd5 COVID-19 Vaccine Dose Study
- Rafael Pharmaceuticals Receives FDA Fast Track Designation for CPI-613® (devimistat) for the Treatment of Pancreatic Cancer
November 11, 2020
- Pfizer Announces Positive Results from Fifth Phase 3 Trial of Abrocitinib, Evaluating Safety and Efficacy Across Different Dosing Regimens
- Pfizer and BioNTech Reach an Agreement to Supply the EU With 200 Million Doses of Their BNT162b2 mRNA-Based Vaccine Candidate Against SARS-CoV-2
- The First Interim Data Analysis of the Sputnik V Vaccine Against COVID-19 Phase III Clinical Trials in the Russian Federation Demonstrated 92% Efficacy
- Brazil's National Health Surveillance Agency Authorizes Resumption of the Phase III Clinical Trial of CoronaVac™
- Samsung Bioepis Announces One-Year Results from Phase 3 Study of SB11, a Proposed Biosimilar to Lucentis® (ranibizumab)
- Moderna Has Completed Case Accrual for First Planned Interim Analysis of its mRNA Vaccine Against COVID-19 (mRNA-1273)
November 12, 2020
- Medicago and GSK Announce Start of Phase 2/3 Clinical Trials of Adjuvanted COVID-19 Vaccine Candidate
- Update on CALAVI Phase II Trials for Calquence in Patients Hospitalised with Respiratory Symptoms of COVID-19
- CureVac’s COVID-19 Vaccine Candidate, CVnCoV, Suitable for Standard Fridge Temperature Logistics
November 13, 2020
- New Novartis Analyses for Investigational Inclisiran Demonstrate Consistently Effective and Sustained LDL-C Reduction at Month 17, Regardless of Age and Gender
- GSK Presents Phase 2b Data on Linerixibat for the Treatment of Cholestatic Pruritus in Primary Biliary Cholangitis (PBC)
- Swissmedic Begins Rolling Review of Moderna’s mRNA Vaccine Against COVID-19 (mRNA-1273)
November 14, 2020
November 15, 2020
- Johnson & Johnson Initiates Second Global Phase 3 Clinical Trial of its Janssen COVID-19 Vaccine Candidate
- Gilead and Novo Nordisk Present New Data from Proof-of-Concept Trial in NASH
- Gilead and Novo Nordisk Present New Data from Proof-of-Concept Trial in NASH
November 16, 2020
- Pfizer Update On Our U.S. COVID-19 Vaccine Candidate Distribution Preparedness
- INOVIO Announces Initiation of Phase 2 Segment of its Phase 2/3 Clinical Trial for its COVID-19 DNA Vaccine Candidate, INO-4800; Trial Will Be Funded by the U.S. Department of Defense
- Bristol Myers Squibb Provides Regulatory Update on Lisocabtagene Maraleucel (liso-cel)
- Moderna Announces Longer Shelf Life for its COVID-19 Vaccine Candidate at Refrigerated Temperatures
- Moderna’s COVID-19 Vaccine Candidate Meets its Primary Efficacy Endpoint in the First Interim Analysis of the Phase 3 COVE Study
- Promising Interim Results from Clinical Trial of NIH-Moderna COVID-19 Vaccine
November 17, 2020
- ViiV Healthcare Receives FDA Breakthrough Therapy Designation for Investigational, Long-Acting Cabotegravir for HIV prevention
- Moderna Announces Supply Agreement with United Kingdom Government to Supply mRNA Vaccine Against COVID-19 (mRNA-1273) if Approved for Use
- European Medicines Agency Begins Rolling Review of Moderna’s mRNA Vaccine Candidate Against COVID-19 (mRNA-1273)
- CytoDyn Files Protocol with U.S. FDA for Phase 2 Clinical Trial for COVID-19 Patients with Long-Hauler Symptoms
November 18, 2020
- Pfizer and BioNTech Conclude Phase 3 Study of COVID-19 Vaccine Candidate, Meeting All Primary Efficacy Endpoints
- FDA Grants Priority Review for Avalglucosidase Alfa, a Potential New Therapy for Pompe Disease
- Rilzabrutinib Granted FDA Fast Track Designation for Treatment of Immune Thrombocytopenia
- Gilead Announces Investigational Long-Acting HIV-1 Capsid Inhibitor, Lenacapavir, Achieves Primary Endpoint in Phase 2/3 Study in Heavily Treatment-Experienced People Living With HIV
- Samsung Bioepis and Biogen Announce FDA Filing Acceptance of SB11, A Proposed Biosimilar Referencing Lucentis® (ranibizumab)
November 19, 2020
- Acurx Announces Positive Phase 2A Clinical Trial Results for Ibezapolstat in C. difficile Infection at Prominent International Conference
- GSK and MMV Present Positive Data on Treatment for Plasmodium vivax Malaria in Children from 6 Months up to 15 Years of Age
- Baricitinib and Remdesivir Combination Receives Emergency Use Authorization from the FDA for the Treatment of Hospitalized Patients with COVID-19
November 20, 2020
- Pfizer and BioNTech to Submit Emergency Use Authorization Request Today to the U.S. FDA for COVID-19 Vaccine
- Lilly's Neutralizing Antibody Bamlanivimab (LY-CoV555) Receives Interim Authorization from Health Canada as a Treatment for COVID-19
- FDA Announces Advisory Committee Meeting to Discuss COVID-19 Vaccine Candidate
November 21, 2020
November 23, 2020
- AB201 Development as a Potential Treatment for COVID-19 Receives U.S. FDA Fast Track Designation
- Merck Advances Phase 3 Trial to Evaluate Investigational Islatravir as Once-Monthly Oral PrEP for Women at High Risk for Acquiring HIV-1
- AZD1222 Vaccine Met Primary Efficacy Endpoint in Preventing COVID-19
- Arizona BioTech Company Successfully Completes Pre-Clinical Testing for Vaccine Alternative to Prevent COVID-19 Infection, Ready for Human Trials
- GSK Starts Phase 3 Study of RSV Maternal Candidate Vaccine
November 24, 2020
November 25, 2020
- RhoVac's Prostate Cancer Drug Candidate, RV001, is granted Fast Track Designation by the FDA
- Polaryx Therapeutics Receives Both Rare Pediatric Disease and Orphan Drug Designations for the Treatment of GM2 Gangliosidosis With PLX-300
- FDA: Remdesivir (Veklury) Approval for the Treatment of COVID-19 - The Evidence for Safety and Efficacy
- Moderna Announces the European Commission’s Approval of Advance Purchase Agreement for Initial 80 Million Doses of mRNA Vaccine Against COVID-19 (mRNA-1273)
- FDA Defers Approval of DaxibotulinumtoxinA for Injection in Glabellar Lines Due to COVID-19 Related Travel Restrictions Impacting Manufacturing Site Inspection
- BioNTech and Fosun Pharma Announce the Start of a Phase 2 Clinical Trial of Lead mRNA COVID-19 Vaccine BNT162b2 in China
November 29, 2020
November 30, 2020
- Novavax Announces COVID-19 Vaccine Clinical Development Progress
- Moderna Announces Primary Efficacy Analysis in Phase 3 COVE Study for Its COVID-19 Vaccine Candidate and Filing Today with U.S. FDA for Emergency Use Authorization
- Moderna Announces Primary Efficacy Analysis in Phase 3 COVE Study for Its COVID-19 Vaccine Candidate and Filing Today with U.S. FDA for Emergency Use Authorization
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