Clinical Trial News Archive - November 2020
November 2, 2020
November 3, 2020
November 4, 2020
November 5, 2020
November 6, 2020
November 9, 2020
- 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
- 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)
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
- 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
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
- Swissmedic Begins Rolling Review of Moderna’s mRNA Vaccine Against COVID-19 (mRNA-1273)
November 14, 2020
November 15, 2020
November 16, 2020
- Pfizer Update On Our U.S. COVID-19 Vaccine Candidate Distribution Preparedness
- 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
- 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
November 19, 2020
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
November 25, 2020
- 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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